Clinical Insights

New Drug/Vaccine Approval

Qfitlia™ (fitusiran) Injection – New Drug Approval – March 28, 2025 – The US Food and Drug Administration (FDA) has approved Qfitlia™ (fitusiran), the first antithrombin-lowering (AT) therapy for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients (aged 12 or older) with hemophilia A or B with or without factor VIII or IX inhibitors. The approval is based on data from the ATLAS phase 3 studies that demonstrated clinically meaningful bleed protection as measured by annualized bleeding rates (ABR) across hemophilia patients with or without inhibitors. <Read More>

Vykat™ XR FDA Approval History – New Drug Approval – March 26, 2025 – Soleno Therapeutics, Inc. (NASDAQ: SLNO), a biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, announced that the U.S. Food and Drug Administration (FDA) has approved Vykat XR™ (diazoxide choline) extended-release tablets, previously referred to as DCCR, for the treatment of hyperphagia in adults and children 4 years of age and older with Prader-Willi syndrome (PWS). Soleno expects Vykat XR™ to be available in the U.S. beginning in April 2025. <Read More> 

Blujepa™ (gepotidacin) Tablets – New Drug Approval – March 25, 2025 – GSK plc (LSE/NYSE: GSK) announced that the US Food and Drug Administration (FDA) has approved Blujepa™ (gepotidacin) for the treatment of female adults (≥40 kg) and paediatric patients (≥12 years, ≥40 kg) with uncomplicated urinary tract infections (uUTIs) caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus and Enterococcus faecalis. Discovered by GSK scientists, Blujepa™ is a first-in-class oral antibiotic with a novel mechanism of action that is part of GSK’s infectious diseases portfolio. <Read More> 

Gozellix® (gallium Ga 68 gozetotide) Injection Kit – New Drug Approval – March 20, 2025 – Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) announces that the United States (U.S.) Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Gozellix® (TLX007-CDx, kit for the preparation of gallium-68 (68Ga) gozetotide injection), Telix’s next-generation PSMA-PET imaging agent for prostate cancer. <Read More> 

Arbli™ (losartan potassium) Oral Suspension – New Drug Approval – March 13, 2025 – Scienture Holdings, Inc. NASDAQ: SCNX), a holding company for existing and planned pharmaceutical operating companies focused on providing enhanced value to patients, physicians and caregivers through developing, bringing to market, and distributing novel specialty products to satisfy unmet market needs, is pleased to announce the U.S. Food and Drug Administration (FDA) has approved SCN-102, one of the products being developed by Scienture, LLC, a wholly owned subsidiary of Scienture Holdings, Inc., with the brand name Arbli™ (losartan potassium) Oral Suspension, 10 mg/mL. <Read More>

Encelto™ (revakinagene taroretcel-lwey) Intravitreal Implant - formerly NT-501 – New Drug Approval – March 5, 2025 – Neurotech Pharmaceuticals, Inc., a private biotech company focused on developing transformative therapies for chronic eye diseases, announced that the U.S. Food and Drug Administration (FDA), has approved Encelto™ (revakinagene taroretcel-lwey) for the treatment of Macular Telangiectasia type 2 (MacTel). <Read More> 

New Indication / Dosage / Formulation Approval

Pluvicto® (lutetium lu 177 vipivotide tetraxetan) Injection – New Label Expansion – March 28, 2025 – Novartis announced that the US Food and Drug Administration (FDA) approved Pluvicto® (lutetium Lu 177 vipivotide tetraxetan) for patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with an androgen receptor pathway inhibitor (ARPI) therapy and are considered appropriate to delay chemotherapy. <Read More> 

Imfinzi® (durvalumab) Injection – New Label Expansion – March 28, 2025 - AstraZeneca’s Imfinzi® (durvalumab) in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by Imfinzi® as adjuvant monotherapy after radical cystectomy (surgery to remove the bladder) has been approved in the US for the treatment of adult patients with muscle-invasive bladder cancer (MIBC). <Read More> 

Cabometyx® (cabozantinib) Tablets – New Label Expansion – March 26, 2025 - Exelixis, Inc. (Nasdaq: EXEL) announced that the U.S. Food and Drug Administration (FDA) has approved Cabometyx® (cabozantinib) for the treatment of 1) adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors (pNET); and 2) adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated extra-pancreatic NET (epNET). <Read More> 

Egrifta WR™ (tesamorelin) Injection – New Label Expansion – March 25, 2025 - Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a commercial-stage biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s supplemental Biologics License Application (sBLA) for the F8 formulation of tesamorelin for injection. The Company will commercialize the new formulation under the tradename Egrifta WR™. <Read More>

Amvuttra® (vutrisiran) Injection – New Label Expansion – March 20, 2025 - Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced the U.S. Food and Drug Administration (FDA) approval of the supplemental New Drug Application (sNDA) for its RNAi therapeutic, Amvuttra® (vutrisiran), for the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality, cardiovascular hospitalizations and urgent heart failure visits. <Read More> 

Fabhalta® (iptacopan) Capsules – New Label Expansion – March 20, 2025 - Novartis announced that oral Fabhalta® (iptacopan) has received U.S. Food and Drug Administration (FDA) approval for the treatment of adults with C3 glomerulopathy (C3G), to reduce proteinuria, making it the first and only treatment approved for this condition. <Read More>

Tremfya® (guselkumab) Injection – New Label Expansion – March 20, 2025 - Johnson & Johnson (NYSE: JNJ) announced that the U.S. Food and Drug Administration (FDA) has approved Tremfya® (guselkumab), the first and only IL-23 inhibitor offering both subcutaneous (SC) and intravenous (IV) induction options, for the treatment of adults with moderately to severely active Crohn’s disease (CD), a chronic inflammatory condition of the gastrointestinal tract. <Read More> 

Keytruda® (pembrolizumab) for Injection – New Label Expansion – March 19, 2025 -  The Food and Drug Administration granted traditional approval to pembrolizumab (Keytruda®, Merck) with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1). <Read More> 

Iluvien® (fluocinolone acetonide) Intravitreal Implant – New Label Expansion – March 12, 2025 - ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) (ANI or the Company) announced that the U.S. Food and Drug Administration (FDA) has approved an expanded label for Iluvien® (fluocinolone acetonide intravitreal implant) that includes an indication for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye (NIU-PS). The approval also includes other updates to the label including to the Warnings and Precautions section. <Read More> 

Furoscix® (furosemide) Injection – New Label Expansion – March 6, 2025 - scPharmaceuticals Inc. (Nasdaq: SCPH) (the “Company”), a pharmaceutical company committed to revolutionizing cardiorenal healthcare through patient-centric innovations, announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for Furoscix® to expand the indication to include treatment of edema in patients with chronic kidney disease (CKD). <Read More>

neffy® (epinephrine) Nasal Spray – New Label Expansion – March 5, 2025 - ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves from allergic reactions that could lead to anaphylaxis, announced that the U.S. Food and Drug Administration (FDA) has approved neffy® 1 mg (epinephrine nasal spray) for the treatment of Type I Allergic Reactions, including anaphylaxis, in children who are aged 4 years and older and weigh 15 to < 30 kilograms (33 to < 66 lb.). This approval represents the first significant innovation in the delivery of epinephrine for this patient population in more than 35 years. <Read More> 

Tevimbra® (tislelizumab-jsgr) Injection – New Label Expansion – March 4, 2025 – BeiGene, Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company that intends to change its name to BeOne Medicines Ltd., announced the U.S. Food and Drug Administration (FDA) has approved Tevimbra® (tislelizumab-jsgr), in combination with platinum-containing chemotherapy, for the first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1). <Read More> 

New Drug Shortage

March 28, 2025

• Carboplatin Injection (Discontinuation)

• Ursodiol Tablet (Discontinuation)

March 24, 2025

• Hydrocortisone Cream (Discontinuation)

• Montelukast Sodium Granule (Discontinuation)

March 18, 2025

• Travoprost Solution/Drops (Discontinuation)

March 17, 2025

• Glipizide Tablet, Extended Release (Discontinuation)

March 5, 2025

• Ibandronate Sodium Injection (Discontinuation)

• Ibutilide Fumarate Injection (Discontinuation)

March 4, 2025

• Amlodipine Besylate; Benazepril Hydrochloride Capsule (Discontinuation)

Updated Drug Shortage

March 30, 2025

• Bupivacaine Hydrochloride Injection (Currently In Shortage)

• Bupivacaine Hydrochloride, Epinephrine Bitartrate Injection (Currently In Shortage)

• Clindamycin Phosphate Injection (Currently In Shortage)

• Dobutamine Hydrochloride Injection (Currently In Shortage)

• Dopamine Hydrochloride Injection (Currently In Shortage)

• Epinephrine Bitartrate, Lidocaine Hydrochloride Injection (Currently In Shortage)

• Hydrocortisone Sodium Succinate Injection (Currently In Shortage)

• Ketamine Hydrochloride Injection (Currently In Shortage)

• Lidocaine Hydrochloride Injection (Currently In Shortage)

• Methotrexate Sodium Injection (Currently In Shortage)

• Methylprednisolone Acetate Injection (Currently In Shortage)

• Penicillin G Benzathine Injection (Currently In Shortage)

• Sodium Chloride 23.4% Injection (Currently In Shortage)

March 28, 2025

• Carboplatin Injection (Currently In Shortage)

March 27, 2025

• Lisdexamfetamine Dimesylate Capsule (Currently In Shortage)

March 24, 2025

• Amino Acid Injection (Currently In Shortage)

• Dextrose Monohydrate 10% Injection (Currently In Shortage)

• Dextrose Monohydrate 5% Injection (Currently In Shortage)

• Dextrose Monohydrate 70% Injection (Currently In Shortage)

• Lactated Ringers Injection (Currently In Shortage)

• Midazolam Hydrochloride Injection (Currently In Shortage)

• Sodium Chloride 0.9% Injection (Currently In Shortage)

• Sodium Chloride 0.9% Irrigation (Currently In Shortage)

• Sterile Water Irrigant (Currently In Shortage)

• Streptozocin Powder, For Solution (Currently In Shortage)

March 21, 2025

• Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet (Currently In Shortage)

• Nitroglycerin Injection (Currently In Shortage)

New Drug Recall and Safety Alerts

Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL Dr. Reddy’s - New Voluntary Recall – March 13, 2025 – Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY; along with its subsidiaries together referred to as “Dr. Reddy’s”), is recalling one Batch/Lot No: A1540076 of Levetiracetam in 0.75% Sodium Chloride Injection, 1,000 mg/100 mL (10 mg/mL) single-dose infusion bags to the consumer level, in the United States. The product is being recalled because the infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL single-dose bag, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL. <Read More>

New Generic/Biosimilar Approval and Launch

Stoboclo® (denosumab-bmwo) Injection - formerly CT-P41 – New Proliaâ Biosimilar Approval – February 28, 2025 – Celltrion announced that the U.S. Food and Drug Administration (FDA) has approved Stoboclo® (CT-P41, denosumab-bmwo) and Osenvelt® (CT-P41, denosumab-bmwo), biosimilars referencing Prolia® (denosumab) and Xgeva® (denosumab) respectively for all indications of reference products. <Read More> 

Osenvelt® (denosumab-bmwo) Injection - formerly CT-P41 – New Xvegaâ Biosimilar Approval – February 28, 2025 – Celltrion announced that the U.S. Food and Drug Administration (FDA) has approved Stoboclo® (CT-P41, denosumab-bmwo) and Osenvelt® (CT-P41, denosumab-bmwo), biosimilars referencing Prolia® (denosumab) and Xgeva® (denosumab) respectively for all indications of reference products. <Read More>

Conexxence® (denosumab-bnht) Injection – New Prolia® Biosimilar Approval – March 25, 2025 – Fresenius announced that the Biologics License Application (BLA) for the denosumab biosimilars Conexxence® (denosumab-bnht) and Bomyntra® (denosumab-bnht) of its operating company Fresenius Kabi has been approved by the U.S. Food and Drug Administration (FDA). These denosumab biosimilars are approved for all indications of the reference products: Prolia® (denosumab) and Xgeva® (denosumab), respectively. In addition, Fresenius’ operating company has reached a Global Settlement with Amgen concerning its denosumab biosimilars. <Read More> 

Bomyntra® (denosumab-bnht) Injection – New Xvegaâ Biosimilar Approval – March 25, 2025 – Fresenius announced that the Biologics License Application (BLA) for the denosumab biosimilars Conexxence® (denosumab-bnht) and Bomyntra® (denosumab-bnht) of its operating company Fresenius Kabi has been approved by the U.S. Food and Drug Administration (FDA). These denosumab biosimilars are approved for all indications of the reference products: Prolia® (denosumab) and Xgeva® (denosumab), respectively. In addition, Fresenius’ operating company has reached a Global Settlement with Amgen concerning its denosumab biosimilars. <Read More>

Clinical and Pharmacy News

The Key to Solving Medication Errors is at the Intersection of Technology and Standards  – April 1, 2025 – By integrating industry standards into e-prescribing software, prescribing organizations can reduce errors to improve patient outcomes and lessen the burden of medication-related errors on healthcare systems. Here’s a look at the new National Council for Prescription Drug Programs (NCPDP) Sig Standard aimed at improving prescription accuracy. 1.5 million people are affected by medication errors each year, posing a significant risk to patients’ safety and increasing healthcare costs. While providers do everything in their power to prevent medication errors, interoperability and lack of visibility into a patient’s medication history can cause serious challenges. <Read More> 

Medical Gaslighting Tops List of Highest Patient Safety Risks – March 28, 2025 – The risks associated with medical professionals dismissing patient, family and caregiver concerns — also called “medical gaslighting” — ranked highest on an annual list of patient safety concerns compiled by the nonprofit organization ECRI. Insufficient governance of AI in health care, the viral spread of medical misinformation, and medical errors and delays in care resulting from cybersecurity breaches also were listed as significant concerns. <Read More>

AI Can Help Doctors Give Intravenous Nutrition to Preemies, Stanford Medicine Study Finds  – March 25, 2025 – An algorithm that learned from tens of thousands of nutrition prescriptions for premature babies could reduce medical errors and better identify what nutrients the smallest patients need. Artificial intelligence can improve intravenous nutrition for premature babies, a Stanford Medicine study has shown. The study, which published March 25 in Nature Medicine, is among the first to demonstrate how an AI algorithm can enable doctors to make better clinical decisions for sick newborns. <Read More> 

Pharmacy Benefit Managers Lining Pockets at Expense of Patients, Say Lawmakers – March 25, 2025 – Third-party companies known as pharmacy benefit managers, which administer prescription drug benefits for health insurance plans, employers, and other organizations including governments, are driving up prescription drug costs, putting small pharmacies out of business, and interfering in the relationship between doctors and their patients, says Sen. Rochelle Nguyen, a Democrat from Las Vegas and the sponsor of Senate Bill 316, a measure that seeks to reform PBMs.  Nevadans are being deprived of “life-changing and life-saving prescription drugs and often have to make difficult decisions based on what they can and cannot afford,” Nguyen told members of the Senate Committee on Labor and Commerce during a hearing Monday, adding escalating prescription prices are just one component of high costs. “This isn’t a magic pill that’s going to solve all our health care problems.” <Read More> 

Spending Growth on GLP-1s Outpaces Specialty Drugs: Evernorth Study – March 25, 2025 – Spending on GLP-1 drugs continues to rise, after outpacing trends among specialty drugs for the first time in 2023, according to a new report from Evernorth. Pharmaceutical spending overall has grown significantly in recent years, but it has accelerated since semaglutide earned approval for chronic weight management in 2021. Afterward, the rate of annual growth rose from 2.1% in 2021 to 12.8% in 2024, according to the report. Specialty pharmacy has traditionally been the key source of growth in pharmacy spend. For comparison, in 2019, spending for traditional medications decreased by 5% while spending on specialty drugs grew by 11.5%. <Read More> 

How Health Systems Can Thrive in Navigating the Specialty Pharmacy Landscape  – March 24, 2025 – Specialty pharmacies must meet complex requirements, introducing administrative requirements that can be challenging for health systems to manage internally. Here some strategies that can be employed. The demand for specialty medications is on the rise in the United States as people living with complex health conditions increasingly rely on new treatments and therapies to manage their health. By partnering with an advisory service, health systems can take advantage of established expertise to evaluate and choose from among the breadth and complexity of potential solutions for operating and optimizing an integrated specialty pharmacy. <Read More>

DEA Warns of Electronic Prescription Fraud – March 21, 2025 – The Drug Enforcement Administration (DEA) recently alerted healthcare providers to a concerning trend: hackers tapping into patient electronic health records (EHRs) to steal doctors’ DEA registration numbers. Armed with those numbers, the thieves have been able to generate tens of thousands of bogus prescriptions and sell them online, the agency explained in a YouTube video. “Electronic prescription fraud is a real emerging trend that we’re seeing all across the country,” said Erin Hager, a DEA diversion investigator in the Phoenix-Tucson Tactical Division Squad. “What’s happening is … bad actors … who have been conducting prescription drug fraud are now utilizing the internet and electronic health record platforms to create electronic prescriptions that they can then send nationwide.” <Read More> 

Ensitrelvir Reduced the Risk for COVID-19 by 67% – March 14, 2025 – Ensitrelvir, an antiviral being developed to prevent COVID-19, reduced the risk of developing the infection by 67% in uninfected people after exposure to SARS-CoV-2 compared with placebo at day 10, according to results presented at CROI 2025, held in San Francisco (abstract 200). The SCORPIO-PEP (Stopping COVID-19 pRogression with early Protease InhibitOr treatment–Post-Exposure Prophylaxis) trial assessed 2,387 study participants, who were 12 years of age and older with a negative screening test for SARS-CoV-2 infection and no symptoms at the time of enrollment. The participants were exposed to a person living in the household who developed symptomatic COVID-19. In this double-blind trial, study participants were randomly assigned to receive 125 mg of ensitrelvir or placebo, once daily, and began prophylaxis within 72 hours of symptom onset in the household member with COVID-19, according to Frederick Hayden, MD, a professor emeritus at the University of Virginia School of Medicine, in Charlottesville. <Read More> 

340B in the News

The Case for 340B Done Right – March 30, 2025 – The federal 340B Drug Pricing Program, which requires pharmaceutical manufacturers participating in Medicaid to sell outpatient drugs at discounted prices to healthcare organizations that care for many uninsured and low-income patients, is facing intense scrutiny and calls for reform. The program’s intent has always been to stretch limited federal resources to reduce the price of outpatient pharmaceuticals and expand health services to our most vulnerable communities. In too many cases, that’s just not what’s happening, and in recent weeks, the media has been shining a spotlight on some of the most cynical deployment of these funds towards profits over patients. <Read More>

HHS Files Brief in 340B Rebate Model Case – March 17, 2025 – The Department of Health and Human Services said its decision to prevent drug companies from implementing a 340B rebate model “was within its statutory authority,” according to a department brief filed March 17 with the U.S. District Court for the District of Columbia. In addition, the brief said the drug companies’ “proposed cash rebate models would have upended the way the 340B Program has operated for more than thirty years” and the agency’s decision to prevent the models from being implemented was “not arbitrary and capricious.” The HHS brief is in cases brought by Eli Lilly, Bristol Meyers Squibb and Novartis. <Read More> 

New Drug/Vaccine Approval

Miudella® (copper) Intrauterine System – New Drug Approval – February 24, 2025 - Sebela Women’s Health Inc., a part of Sebela Pharmaceuticals, announced that the U.S. Food and Drug Administration (FDA) granted approval of Miudella® (copper intrauterine system) for the prevention of pregnancy in females of reproductive potential for up to three years. Miudella® is a next-generation, hormone-free, low-dose copper intrauterine device or IUD, the first to be approved by the FDA in the United States in over 40 years. <Read More> 

Ctexli™ (chenodiol) Tablets – New Drug Approval – February 21, 2025 - The U.S. Food and Drug Administration approved Ctexli™ (chenodiol) for the treatment of cerebrotendinous xanthomatosis (CTX) in adults. Ctexli™ is the first FDA-approved drug to treat CTX, a very rare lipid storage disease. <Read More> 

Romvimza™ (vimseltinib) Capsules – New Drug Approval – February 14, 2025 - The Food and Drug Administration approved vimseltinib (Romvimza™, Deciphera Pharmaceuticals, LLC), a kinase inhibitor, for adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity. <Read More> 

Penmenvy™ (meningococcal groups A, B, C, W, and Y vaccine) Lyophilized Powder for Injection – New Vaccine Approval – February 14, 2025 - GSK plc (LSE/NYSE: GSK) announced that the US Food and Drug Administration (FDA) has approved Penmenvy™ (Meningococcal Groups A, B, C, W, and Y Vaccine) for use in individuals aged 10 through 25 years. The vaccine targets five major serogroups of Neisseria meningitidis (A, B, C, W, and Y) which commonly cause invasive meningococcal disease (IMD).  <Read More> 

Vimkunya™ (chikungunya vaccine, recombinant) Injection – New Vaccine Approval – February 14, 2025 - Bavarian Nordic A/S (OMX: BAVA) announced that the U.S. Food and Drug Administration (FDA) has approved Vimkunya™ (Chikungunya Vaccine, Recombinant) for injection, the first virus-like particle (VLP) single-dose chikungunya vaccine in the U.S. for persons 12 years of age and older. The FDA approved Vimkunya™ under Priority Review, based on results from two phase 3 clinical trials which enrolled more than 3,500 healthy individuals 12 years of age and older. <Read More> 

Gomekli™ (mirdametinib) Capsules and Tablets for Oral Suspension – New Drug Approval – February 11, 2025 - The Food and Drug Administration approved mirdametinib (Gomekliä, SpringWorks Therapeutics, Inc.), a kinase inhibitor, for adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection. <Read More> 

Emblaveo™ (avibactam and aztreonam) Lyophilized Powder for Injection – New Drug Approval – February 7, 2025 - AbbVie (NYSE: ABBV) announced that the U.S. Food and Drug Administration (FDA) has approved Emblaveo™ (aztreonam and avibactam), as the first and only fixed-dose, intravenous, monobactam/β-lactamase inhibitor combination antibiotic. It is approved in combination with metronidazole, for patients 18 years and older who have limited or no alternative options for the treatment of complicated intra-abdominal infections (cIAI), including those caused by the following susceptible Gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Enterobacter cloacae complex, Citrobacter freundii complex, and Serratia marcescens. <Read More> 

Onapgo™ (apomorphine hydrochloride) Subcutaneous Infusion Device - formerly SPN-830 – New Infusion Device Approval – February 4, 2025 - Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, announced that the U.S. Food and Drug Administration (FDA) approved Onapgo™ (apomorphine hydrochloride) injection, formerly known as SPN-830, as the first and only subcutaneous apomorphine infusion device for the treatment of motor fluctuations in adults with advanced Parkinson’s disease (PD). Supernus will make Onapgo™ available in the second quarter of 2025 with a support team of experts, including a robust nurse education program, and access support at launch. <Read More> 

New Indication / Dosage / Formulation Approval

TNKase® (tenecteplase) Lyophilized Powder for Injection – New Label Expansion – March 3, 2025 - Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced that the U.S. Food and Drug Administration (FDA) has approved TNKase® (tenecteplase), a thrombolytic or clot-dissolving agent, for the treatment of acute ischemic stroke (AIS) in adults. This approval of TNKase® marks Genentech’s second approval for stroke, reinforcing the company's long-standing dedication to advancing stroke care as the developer of the only two FDA-approved medicines for AIS, TNKase® and Activase® (alteplase). <Read More> 

Odactra® (house dust mite allergen extract) Sublingual Tablets – New Label Expansion – February 27, 2025 - ALK (ALKB:DC / OMX: ALK B) announced that the US Food and Drug Administration (FDA) has approved ALK’s Odactra® tablet for use in young children with house dust mite (HDM) allergy Odactra® is now indicated to treat HDM-induced allergic rhinitis, with or without conjunctivitis, in children aged five through 11, in addition to patients aged 12 through 65. Odactra® is an allergy immunotherapy (AIT) tablet which dissolves under the tongue and helps patients reduce their allergy symptoms and their reliance on symptomatic medication. <Read More> 

Sublocade® (buprenorphine) Sustained-Release Injection – New Label Expansion – February 24, 2025 - Indivior PLC (Nasdaq/LSE: INDV), a global leader in addiction treatment, announced that the U.S. Food and Drug Administration (FDA) has approved label changes for Sublocade® including a rapid initiation protocol and alternative injection sites, marking a significant advancement in the treatment of moderate to severe opioid use disorder (OUD). Key label changes include:  1) Rapid initiation Protocol: Healthcare providers can now initiate treatment with Sublocade® after a single dose of transmucosal buprenorphine and a one-hour observation period to confirm tolerability, 2) Alternative Injection Sites: Sublocade® can now be administered subcutaneously in the abdomen, thigh, buttock, or back of the upper arm, offering patients and healthcare providers increased flexibility in treatment administration. <Read More> 

Izervay™ (avacincaptad pegol) Intravitreal Solution – New Label Expansion – February 12, 2025 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) announced the U.S. Food and Drug Administration (FDA) approved expanded U.S. Prescribing information for Izervay™ (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). As a result, Izervay™ is now approved without a limitation on duration of dosing—providing physicians and patients with greater flexibility when managing GA. <Read More> 

Evrysdi® (risdiplam) Powder for Oral Solution and Oral Tablets – New Label Expansion – February 12, 2025 - Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced that the U.S. Food and Drug Administration (FDA) has approved a New Drug Application (NDA) for an Evrysdi® (risdiplam) tablet for people living with spinal muscular atrophy (SMA). Evrysdi® is the only non-invasive disease-modifying treatment for SMA. The 5 mg Evrysdi® tablet can either be swallowed whole or dispersed in water. <Read More> 

Adcetris® (brentuximab vedotin) Injection – New Label Expansion – February 12, 2025 - Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Adcetris® (brentuximab vedotin) in combination with lenalidomide and a rituximab product for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy who are not eligible for autologous hematopoietic stem cell transplantation (auto-HSCT) or chimeric antigen receptor (CAR) T-cell therapy. <Read More>  

Susvimo® (ranibizumab) Injection for Intravitreal Use via Ocular Implant – New Label Expansion – February 4, 2025 - Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced that the U.S. Food and Drug Administration (FDA) has approved Susvimo® (ranibizumab injection) 100 mg/mL for the treatment of diabetic macular edema (DME), a leading cause of vision loss in adults with diabetes, affecting more than 29 million adults worldwide. Susvimo® is the first and only FDA-approved treatment shown to maintain vision in people with DME with fewer treatments than standard-of-care eye injections. Susvimo® is now available to U.S. retina specialists and their patients with DME. <Read More> 

Ozempic® (semaglutide) Injection – New Label Expansion – January 28, 2025 - Novo Nordisk announced that the U.S. Food and Drug Administration (FDA) has approved Ozempic® to reduce the risk of kidney disease worsening, kidney failure (end-stage kidney disease), and death due to cardiovascular disease in adults with type 2 diabetes and chronic kidney disease (CKD). This approval, along with its existing indications for adults with type 2 diabetes to improve glycemic control and to reduce the risk of major cardiovascular events in adults also with known heart disease, establishes Ozempic® (semaglutide) injection 0.5 mg, 1 mg, or 2 mg as the most broadly indicated glucagon-like peptide-1 receptor agonist (GLP-1 RA) in its class. <Read More> 

Leqembi® (lecanemab-irmb) Injection – New Label Expansion – January 26, 2025 - Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced that the U.S. Food and Drug Administration (FDA) has approved the Supplemental Biologics License Application (sBLA) for once every four weeks lecanemab-irmb (U.S. brand name: Leqembi®) intravenous (IV) maintenance dosing. Leqembi® is indicated for the treatment of Alzheimer's disease (AD) in patients with mild cognitive impairment (MCI) or mild dementia stage of disease (collectively referred to as early AD) in the U.S. After 18 months of once every two weeks initiation phase, a transition to the maintenance dosing regimen of 10 mg/kg once every four weeks may be considered or the regimen of 10 mg/kg once every two weeks may be continued. <Read More> 

New Drug Shortage

March 4, 2025

• Amlodipine Besylate; Benazepril Hydrochloride Capsule (Discontinuation)

March 3, 2025

• Acyclovir Ointment (Discontinuation)

• Adalimumab-adbm Injection (Discontinuation)

• Bacitracin Ophthalmic Ointment (Currently In Shortage)

• Dapagliflozin; Saxaglipitin Hydrochloride Tablet (Discontinuation)

February 28, 2025

• Methylphenidate Film, Extended Release (Currently In Shortage)

• Pimecrolimus Cream (Discontinuation)

February 26, 2025

• Tolterodine Tartrate Capsule, Extended Release (Discontinuation)

• Tolterodine Tartrate Tablet (Discontinuation)

February 20, 2025

• Silodosin Capsule (Discontinuation)

Updated Drug Shortage

March 4, 2025

• Cromolyn Sodium Concentrate (Currently In Shortage)

• Flurazepam Hydrochloride Capsule (Currently In Shortage)

March 3, 2025

• Methylphenidate Film, Extended Release (Currently In Shortage)

February 28, 2025

• Cefotaxime Sodium Powder, for Solution (Currently In Shortage)

• Dexmedetomidine Hydrochloride Injection (Currently In Shortage)

February 27, 2025

• Triamcinolone Acetonide Injection (Currently In Shortage)

February 26, 2025

• Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine

• Saccharate, Dextroamphetamine Sulfate Tablet (Currently In Shortage)

• Bupivacaine Hydrochloride Injection (Currently In Shortage)

• Bupivacaine Hydrochloride, Epinephrine Bitartrate Injection (Currently In Shortage)

• Clonazepam Tablet (Currently In Shortage)

• Dobutamine Hydrochloride Injection (Currently In Shortage)

• Epinephrine Bitartrate, Lidocaine Hydrochloride Injection (Currently In Shortage)

• Hydrocortisone Sodium Succinate Injection (Currently In Shortage)

• Hydromorphone Hydrochloride Injection (Currently In Shortage)

• Lidocaine Hydrochloride Injection (Currently In Shortage)

• Lorazepam Injection (Currently In Shortage)

• Methotrexate Sodium Injection (Currently In Shortage)

• Methylprednisolone Acetate Injection (Currently In Shortage)

• Midazolam Hydrochloride Injection (Currently In Shortage)

• Morphine Sulfate Injection (Currently In Shortage)

• Penicillin G Benzathine Injection (Currently In Shortage)

• Quinapril Hydrochloride Tablet (Currently In Shortage)

• Quinapril/Hydrochlorothiazide Tablet (Currently In Shortage)

• Riluzole Oral Suspension (Currently In Shortage)

• Sodium Bicarbonate Injection (Currently In Shortage)

• Sodium Chloride 0.9% Injection (Currently In Shortage)

• Sodium Chloride 23.4% Injection (Currently In Shortage)

• Sterile Water Injection (Currently In Shortage)

New Drug Recall and Safety Alerts

Phenylephrine 40 mg Added to 0.9% Sodium Chloride 250 mL in 250 mL Excel Bags by Central Admixture Pharmacy Services (CAPS) - New Voluntary Recall – February 24, 2025 - Central Admixture Pharmacy is recalling three lots of Phenylephrine 40 mg added to 0.9% Sodium Chloride 250 mL in 250 mL Excel Bags (NDC: 71285-6092-1) to the hospital level. The product is being recalled because CAPS was notified by their raw material supplier of the detection of visible black particulate matter in a single sealed vial of Phenylephrine Hydrochloride. <Read More>

Potassium Chloride Injection, 20 mEq and Potassium Chloride Injection, 10 mEq by ICU Medical – New Voluntary Recall – February 13, 2025 – ICU Medical, Inc. is voluntarily recalling one lot each of Potassium Chloride Inj. bags with overwrap labels 10mEq, packaged in cases of Potassium Chloride Inj. 20 mEq, to the user level. ICU medical has received a customer complaint which states that bags of Potassium Chloride Inj. 20 mEq have incorrect overwrap labels which state Potassium Chloride Inj. 10 mEq. <Read More> 

New Generic/Biosimilar Approval and Launch

Ospomyv™ (denosumab-dssb) Injection – New Prolia® Biosimilar Approval – February 16, 2025 - Samsung Bioepis Co., Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for Ospomyv™ (denosumab-dssb; SB16; 60 mg pre-filled syringe) and Xbryk™ (denosumab-dssb; SB16; 120 mg vial), biosimilars referencing Prolia® and Xgeva® respectively. In addition, the FDA granted a provisional determination for both Ospomyv™ and Xbryk™'s interchangeability designation. <Read More>

Xbryk™ (denosumab-dssb) Injection – New Xgeva® Biosimilar Approval – February 16, 2025 - Samsung Bioepis Co., Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for Ospomyv™ (denosumab-dssb; SB16; 60 mg pre-filled syringe) and Xbryk™ (denosumab-dssb; SB16; 120 mg vial), biosimilars referencing Proliaâ and Xgeva® respectively. In addition, the FDA granted a provisional determination for both Ospomyv™ and Xbryk™'s interchangeability designation. <Read More> 

Merilog™ (insulin aspart-szjj) Injection – New Novolog® Biosimilar Approval – February 14, 2025 - The U.S. Food and Drug Administration approved Merilog™ (insulin-aspart-szjj) as biosimilar to NovoLog (insulin aspart) for the improvement of glycemic control in adults and pediatric patients with diabetes mellitus. Merilog™, a rapid-acting human insulin analog, is the first rapid-acting insulin biosimilar product approved by the FDA. As a rapid-acting insulin, Merilog™ helps to lower mealtime blood sugar spikes to improve control of blood sugar in people with diabetes. The approval is for both a 3 milliliter (mL) single-patient-use prefilled pen and a 10 milliliter (mL) multiple-dose vial. <Read More>

Clinical and Pharmacy News

ASTRO Issues Clinical Guideline on Radiation Therapy for Anal Cancer – February 27, 2025 - A new clinical guideline from the American Society for Radiation Oncology (ASTRO) provides guidance on the use of radiation therapy to treat adult patients with primary squamous cell carcinoma of the anal canal and anal margin. The guideline, ASTRO’s first for anal cancer, is published in Practical Radiation Oncology. Although anal cancer is relatively rare compared with colon or rectal cancers, incidence and mortality rates have risen steadily over the past 2 decades, particularly among adults in their 50s. An estimated 10,540 Americans are diagnosed with anal cancer each year, mostly frequently Black men and White women. Overall, women are more than twice as likely as men to develop the disease. <Read More>

Eli Lilly to Expand US Pharma Manufacturing With Four New Sites – February 27, 2025 – Eli Lilly has announced plans to expand its domestic medicine production in the US by establishing four new pharmaceutical manufacturing sites. The move increases the company’s total US capital expansion commitments to more than $50bn since 2020. Three of the four sites will concentrate on active pharmaceutical ingredients manufacturing, aiming to reshore essential small molecule chemical synthesis capabilities and reinforce the company’s supply chain. <Read More> 

How AI Drug Manufacturing is Changing the Game – February 26, 2025 – In drug discovery, companies face a long timeline and steep costs to receive drug approvals. The likelihood of getting to market successfully is less than 10%, according to a 2022 study. “Even small advancements in time-to-lead optimization and improvements in the likelihood of clinical success are important to addressing the thousands of diseases that today have no known treatment or cure,” writes Anthony Costa, NVIDIA director of digital biology, in a HealthTech article. Artificial intelligence helps with process control during drug production and can speed up time to market. Drug discovery and drug manufacturing are both part of pharma AI. <Read More> 

J&J Sues Samsung Bioepis Over ‘Surreptitious’ Breach of Stelaraâ Biosimilar Contract – February 25, 2025 – Johnson & Johnson (J&J) has sued Samsung Bioepis over a ‘concealed plan’ to supply an unnamed health conglomerate with a private label biosimilar version of blockbuster Stelera (ustekinumab). According to the lawsuit filed on 24 February in New Jersey, J&J alleges that Samsung Bioepis has conducted a “surreptitious and deliberate breach” that “threatens irreparable harm to Janssen” in the time since the existing settlement was reached. Developed by subsidiary Janssen, now J&J Innovative Medicine, Stelara has been J&J’s top selling drug since 2019, bringing in peak sales of $11bn in 2023. It is used to treat multiple inflammatory skin and bowel conditions. <Read More> 

How Modern Technology is Shaping the Future of Pharmacy Benefit Management – February 24, 2025 – The pharmacy benefits management (PBM) industry is at a turning point. While 70% of the market still relies on decades-old systems from the big three PBMs, modern technology is quickly transforming the landscape.  ’s cloud-based platforms provide real-time data, advanced analytics and seamless integration into the broader healthcare ecosystem. These innovations enable health plans to respond faster, improve member adherence and optimize benefit management. The shift to modern technology is redefining how organizations manage pharmacy benefits. <Read More> 

FDA Declares End to Semaglutide Shortage; Clock Ticking on Compounded Versions – February 24, 2025 – In the wake of the FDA’s Feb. 21, 2025 announcement declaring an end to the semaglutide (Ozempicâ/Wegovyâ, Novo Nordisk) shortage, stakeholders in the compounding arena offered their take on the agency’s decision and how it may affect patients’ ability to access—and afford—the blockbuster weight-loss medication. The most immediate result of the action will be to dramatically limit the ability of compounding pharmacies to make their own versions of semaglutide. The FDA announcement gave 503A compounders 60 calendar days to stop production of “essentially a copy” of the GLP-1 medications until April 22 this year; 503B compounders were given 90 days, until May 22. <Read More> 

Twenty Drug Interactions You Should Know About – February 21, 2025 – One of the scariest moments of my life happened in 2022 when my father, Tom Donvito, then 75 and unaware of any allergies, experienced an anaphylactic reaction to a hornet sting. After he passed out, my panicked mother called 911, but when the emergency medical technicians arrived, the shot of epinephrine they gave my dad didn’t work – and neither did the second. Why? My dad was on beta blockers, which reduce the effectiveness of epinephrine. Luckily, doctors were able to stabilize him at the hospital. Looking back now, my father doesn’t remember if there was a warning on the safety insert that came with his beta blockers. The EMTs didn’t ask if he was on beta blockers either. <Read More>  

Amazon Joins Forces With Memorial Sloan Kettering for AI-Powered Drug Discovery – February 19, 2025 – Amazon Web Services (AWS) and US-based Memorial Sloan Kettering Cancer Center (MSK) have announced a partnership to leverage artificial intelligence (AI), high-performance computing (HPC), and cloud technology to accelerate cancer research and drug discovery. AWS is one of the world’s largest cloud providers, recently reporting a $107.6bn in segment sales in 2024. The partnership will focus on building a longitudinal data resource for cancer research at MSK, a cancer treatment and research institution based in New York City. <Read More>

How PBMs Limit Access to MS Therapies – February 18, 2025 - The rising cost of specialty medications has long been a challenge for patients with chronic diseases, particularly those living with multiple sclerosis. The Federal Trade Commission’s January 2025 report sheds light on how pharmacy benefit managers are driving up prices, increasing barriers to access, and limiting competition in the specialty drug market. According to the report, pharmacy benefit managers (PBMs) marked up specialty generic drugs by hundreds or even thousands of percent, generating $7.3 billion in revenue over five years. This price inflation disproportionately affects multiple sclerosis (MS) patients, who rely on specialty generics such as Ampyraâ to manage symptoms and maintain their quality of life. However, instead of benefiting from the cost savings generics are supposed to offer, these patients often find their medications out of reach. <Read More> 

Pharmacy Benefit Managers Raised Prices by Over 1,000% on Specialty Drugs – February 14, 2025 – Reporters covering the cost of prescription drugs should be aware of two reports from the Federal Trade Commission on pharmacy benefit managers (PBMs): the first on July 9 and the second on Jan. 14. In the latest report, “Specialty Generic Drugs: A Growing Profit Center for Vertically Integrated Pharmacy Benefit Managers,” the FTC staff reported that the three largest PBMs drove up the price of specialty generic drugs for patients with cancer, multiple sclerosis, HIV and pulmonary hypertension by more than 1,000% in some cases and by hundreds of percent in other cases. Together, the nation’s three largest PBMs manage 79% of all prescription drug claims for some 270 million Americans, the FTC staff noted in the July report, “Pharmacy Benefit Managers: The Powerful Middlemen Inflating Drug Costs and Squeezing Main Street Pharmacies.” <Read More> 

The Remarkable Evolution of HIV/AIDS Treatment – February 14, 2025 – HIV/AIDS was a death sentence. Until LGBT people, people living with HIV, and allies demanded action and pushed the scientific establishment to address the crisis. What followed is nothing short of extraordinary. First came the discovery that AZT (azidothymidine), a drug previously abandoned as a failed cancer treatment, suppressed HIV replication in a petri dish without killing normal cells. Under significant pressure from activists and the public, the FDA fast-tracked testing and review, and approved the drug to treat AIDS in 1987. It worked. <Read More> 

LAAO or DOAC? Mayo Clinic AI Helps Guide Treatment of AFib Patients – February 14, 2025 – Researchers have developed a new artificial intelligence (AI) algorithm that can identify atrial fibrillation (AFib) patients who may benefit from left atrial appendage occlusion (LAAO). The group shared its findings in JACC: Clinical Electrophysiology. “Lifelong oral anticoagulation is recommended for stroke prevention in most patients with AFib, and clinical guidelines recommend direct oral anticoagulant (DOAC) in preference to warfarin in most patients,” wrote first author Che Ngufor, PhD, an AI specialist with Mayo Clinic, and colleagues. “However, oral anticoagulation increases the risk of bleeding and the adherence to lifelong drug therapy is poor, leaving many patients undertreated. Transcatheter LAAO offers an attractive alternative to lifelong drug therapy, but how to select the best candidates for LAAO remains unclear in everyday clinical practice.” <Read More> 

Identifying Weak Planks on the Bridge to Medication Safety – February 12, 2025 – A new review of all 50 state boards of pharmacy regulations by the Institute for Safe Medication Practices has shown that only one or two boards provided detailed guidance for pharmacy drug labeling, ISMP presenters noted at the NASP 2024 Annual Meeting & Expo, in Nashville, Tenn. “Most boards have just generalized, high-level suggestions outside listing requirements for a legal label,” said Jennifer Young, PharmD, BCPS, CSP, a medication safety specialist with ISMP, who noted that an ISMP fellow prepared the pharmacy board review in preparation for the NASP presentation. “I’ve worked in a variety of places in my career, and in each pharmacy, sometimes each store, they had their own preferences and nuances.” <Read More>

340B in the News

The 340B Reimbursement Battle: What Hospitals and Insurers Need to Know – February 12, 2025 – The U.S. Supreme Court’s ruling in American Hospital Association (“AHA”) v. Becerra (2022) sent shockwaves through the 340B drug pricing program when it held that CMS’ reduction of reimbursement for drugs purchased under the 340B program was not permitted by law. The Supreme Court chose not to address potential remedies and remanded the case back to the D.C. District Court for further proceedings on how to correct the underpayments. Instead of vacating the unlawful reimbursement rates, the District Court decided to remand without vacatur, allowing HHS the opportunity to remediate its underpayments. AHA v. Becerra (2023). <Read More> 

New Drug/Vaccine Approval

Journavx™ (suzetrigine) Tablets - formerly VX-548 – New Drug Approval – January 30, 2025 - The U.S. Food and Drug Administration approved Journavx™ (suzetrigine) 50 milligram oral tablets, a first-in-class non-opioid analgesic, to treat moderate to severe acute pain in adults. Journavx™ reduces pain by targeting a pain-signaling pathway involving sodium channels in the peripheral nervous system, before pain signals reach the brain. Journavx™ is the first drug to be approved in this new class of pain management medicines. <Read More> 

Symbravo™ (meloxicam and rizatriptan) Tablets - formerly AXS-07 – New Drug Approval – January 30, 2025 - Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, announced that the U.S. Food and Drug Administration (FDA) has approved Symbravo® (meloxicam and rizatriptan) for the acute treatment of migraine with or without aura in adults. Symbravo® represents a novel multi-mechanistic approach to treating migraine that targets multiple pathways underlying a migraine attack. <Read More> 

Grafapex™ (treosulfan) Lyophilized Powder for Injection – New Drug Approval – January 22, 2025 - Medexus Pharmaceuticals (TSX: MDP) (OTCQX: MEDXF) is pleased to provide a business update regarding the successful completion of the regulatory review process for Grafapex™ (treosulfan) for injection with the US Food and Drug Administration and, in addition, to announce preliminary estimates of the company's operating and financial results for the company's third fiscal quarter ended December 31, 2024 (which remain subject to completion of Medexus's financial closing procedures). All dollar amounts in this news release are in US dollars unless specified otherwise. <Read More> 

Datroway® (datopotamab deruxtecan-dlnk) Lyophilized Powder for Injection – New Drug Approval – January 17, 2025 - The Food and Drug Administration approved datopotamab deruxtecan-dlnk (Datroway®, Daiichi Sankyo, Inc.), a Trop-2-directed antibody and topoisomerase inhibitor conjugate, for adult patients with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC1+ or IHC2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease. <Read More> 

Opdivo® Qvantig™ (nivolumab and hyaluronidase-nvhy) Subcutaneous Injection – New Drug Approval – December 27, 2024 - The Food and Drug Administration approved nivolumab and hyaluronidase-nvhy (Opdivo® Qvantig™, Bristol Myers Squibb Company) for subcutaneous injection across approved adult, solid tumor nivolumab (Opdivo®, Bristol Myers Squibb Company) indications as monotherapy, monotherapy maintenance following completion of Opdivo® plus Yervoy® (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib. <Read More> 

Alhemo® (concizumab-mtci) Injection – New Drug Approval – December 20, 2024 - The U.S. Food and Drug Administration has approved Alhemo® (concizumab-mtci) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A with factor VIII inhibitors or hemophilia B with factor IX inhibitors. Alhemo® is injected subcutaneously (under the skin) daily. <Read More> 

Alyftrek™ (deutivacaftor, tezacaftor and vanzacaftor) – New Drug Approval – December 20, 2024 - Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced that the U.S. Food and Drug Administration (FDA) has approved Alyftrek™ (vanzacaftor/tezacaftor/deutivacaftor), a once-daily next-in-class triple combination cystic fibrosis transmembrane conductance regulator (CFTR) modulator for the treatment of cystic fibrosis (CF) in people 6 years and older who have at least one F508del mutation or another mutation in the CFTR gene that is responsive to Alyftrek™. <Read More> 

Tryngolza™ (olezarsen) Injection – New Drug Approval – December 19, 2024 - The U.S. Food and Drug Administration has approved Tryngolza™ (olezarsen), used with diet, to reduce triglycerides (TG) in adults with familial chylomicronemia syndrome (FCS). This is a first-in-class approval, meaning Tryngolza™ uses a new mechanism of action, or works differently in the body, than other therapies currently used to treat FCS. Tryngolza™ is injected subcutaneously (under the skin) once per month. <Read More> 

Symvess™ (acellular tissue engineered vessel-tyod) for Surgical Vascular Implantation – New Drug Approval – December 19, 2024 - The U.S. Food and Drug Administration approved Symvess™, the first acellular tissue engineered vessel indicated for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization (restoration of blood flow) is needed to avoid imminent limb loss, and autologous vein graft is not feasible. Vascular trauma occurs when a blood vessel is injured such as a rupture of an artery in the extremities, which can lead to serious, life-threatening complications such as hemorrhage or blood clotting. <Read More> 

Ryoncil® (remestemcel-L-rknd) Cell Suspension for Intravenous Infusion – New Drug Approval – December 18, 2024 - The FDA approved remestemcel-L-rknd (brand name Ryoncil®), an allogeneic bone marrow-derived mesenchymal stromal cell therapy, for steroid-refractory acute graft versus host disease in pediatric patients 2 months of age and older. Ryoncil® is the first FDA-approved mesenchymal stromal cell therapy. <Read More> 

Ensacove™ (ensartinib) Capsules – New Drug Approval – December 18, 2024 - The Food and Drug Administration approved ensartinib (Ensacove™, Xcovery Holdings, Inc.) for adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not previously received an ALK-inhibitor. <Read More> 

Crenessity™ (crinecerfont) Capsules and Oral Solution – New Drug Approval – December 13, 2024 - The U.S. Food and Drug Administration approved Crenessity™ (crinecerfont) to be used together with glucocorticoids (steroids) to control androgen (a testosterone-like hormone) levels in adults and pediatric patients 4 years of age and older with classic congenital adrenal hyperplasia (CAH). <Read More>  

Unloxcyt™ (cosibelimab-ipdl) Injection – New Drug Approval – December 13, 2024 - The Food and Drug Administration approved cosibelimab-ipdl (Unloxcyt™, Checkpoint Therapeutics, Inc.), a programmed death ligand-1 (PD-L1) blocking antibody, for adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation. <Read More> 

Bizengri® (zenocutuzumab-zbco) Injection – New Drug Approval – December 4, 2024 - The Food and Drug Administration granted accelerated approval to zenocutuzumab-zbco (Bizengri®, Merus N.V.) for adults with the following:  1) advanced, unresectable, or metastatic non-small cell lung cancer (NSCLC) harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy, or 2) advanced, unresectable, or metastatic pancreatic adenocarcinoma harboring a NRG1 gene fusion with disease progression on or after prior systemic therapy. This represents the first FDA approval of a systemic therapy for patients with NSCLC or pancreatic adenocarcinoma harboring an NRG1 gene fusion. <Read More> 

Attruby™ (acoramidis) Tablets – New Drug Approval – November 25, 2024 - The U.S. Food and Drug Administration has approved Attruby™ (acoramidis) to treat adults with cardiomyopathy (disorder that affects heart muscle) of wild-type or variant (hereditary) transthyretin-mediated amyloidosis (ATTR-CM) to reduce death and hospitalization related to heart problems. ATTR-CM is a rare and serious disease that affects the heart muscle. In patients with ATTR-CM, there is a build-up of protein deposits in the heart, causing the walls of the heart to become stiff, and making the left ventricle unable to properly relax and fill with blood (called cardiomyopathy). As the condition progresses, the heart can become unable to pump blood out adequately, causing heart failure. <Read More> 

Imkeldi™ (imatinib mesylate) Oral Solution – New Drug Approval – November 22, 2024 - Shorla Oncology (‘Shorla’), a U.S.-Ireland specialty pharmaceutical company, announced that the FDA has approved Imkeldi™ (imatinib) oral solution, the first oral liquid form of imatinib to treat certain forms of leukemia and other cancers. “We are thrilled to offer an oral solution option for patients with leukemia and other cancers, a meaningful advancement for thousands in need,” said Sharon Cunningham, chief executive officer of Shorla. “Oral solutions may ensure more precise and consistent dosing, offering a convenient alternative to compounding for patients who have difficulty swallowing or require dosing tailored to body surface area.” <Read More> 

Rapiblyk™ (landiolol) Lyophilized Powder for Injection – New Drug Approval – November 22, 2024 - AOP Orphan Pharmaceuticals GmbH (AOP Health), based in Vienna, Austria, announced that the U.S. Food and Drug Administration (FDA) has granted regulatory approval for Rapiblyk™ (landiolol) in the hospital critical care setting for the treatment of the severe heart condition supraventricular tachycardia (atrial fibrillation and atrial flutter). The approval is based on clinical studies which demonstrated that Rapiblyk™ (landiolol) enables rapid management of the heart rate with minimal reduction of blood pressure. The approval will provide patients in the U.S. with a new treatment option and is an important step for AOP Health in bringing its mission to help patients and make an impact on rare diseases and critical care to the United States for the first time. <Read More> 

New Indication/Dosage/Formulation Approval

Enhertu® (fam-trastuzumab deruxtecan-nxki) Injection – New Label Expansion – January 28, 2025 – AstraZeneca and Daiichi Sankyo’s Enhertu® (trastuzumab deruxtecan) has been approved in the US for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determined by a Food and Drug Administration (FDA)-approved test, that has progressed on one or more endocrine therapies in the metastatic setting. <Read More> 

Ozempic® (semaglutide) Injection – New Label Expansion – January 28, 2025 – Novo Nordisk announced that the U.S. Food and Drug Administration (FDA) has approved Ozempic® to reduce the risk of kidney disease worsening, kidney failure (end-stage kidney disease), and death due to cardiovascular disease in adults with type 2 diabetes and chronic kidney disease (CKD). This approval, along with its existing indications for adults with type 2 diabetes to improve glycemic control and to reduce the risk of major cardiovascular events in adults also with known heart disease, establishes Ozempic® (semaglutide) injection 0.5 mg, 1 mg, or 2 mg as the most broadly indicated glucagon-like peptide-1 receptor agonist (GLP-1 RA) in its class. <Read More> 

Leqembi® (lecanemab-irmb) Injection – New Label Expansion – January 27, 2025 – Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (NASDAQ: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced that the U.S. Food and Drug Administration (FDA) has approved the Supplemental Biologics License Application (sBLA) for once every four weeks lecanemab-irmb (U.S. brand name: Leqembi®) intravenous (IV) maintenance dosing. Leqembi® is indicated for the treatment of Alzheimer's disease (AD) in patients with mild cognitive impairment (MCI) or mild dementia stage of disease (collectively referred to as early AD) in the U.S. After 18 months of once every two weeks initiation phase, a transition to the maintenance dosing regimen of 10 mg/kg once every four weeks may be considered or the regimen of 10 mg/kg once every two weeks may be continued. <Read More> 

Spravato® (esketamine) Nasal Spray – New Label Expansion – January 17, 2025 – Johnson & Johnson (NYSE: JNJ) announced the U.S. Food and Drug Administration (FDA) approval of a supplemental New Drug Application (sNDA) for Spravato® (esketamine) CIII nasal spray, making this innovative treatment the first and only monotherapy for adults living with major depressive disorder (MDD) who have had an inadequate response to at least two oral antidepressants. <Read More> 

Lumakras® (sotorasib) Tablets – New Label Expansion – January 16, 2025 – The Food and Drug Administration approved sotorasib (Lumakras®, Amgen Inc.) with panitumumab (Vectibix®, Amgen Inc.) for adult patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC), as determined by an FDA-approved test, who have received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. <Read More> 

Calquence® (acalabrutinib) Capsules and Tablets – New Label Expansion – January 16, 2025 – AstraZeneca’s Calquence® (acalabrutinib) in combination with bendamustine and rituximab has been approved in the US for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation. The approval was granted by the Food and Drug Administration (FDA) after securing Priority Review. It was based on results from the ECHO Phase III trial which were presented at the European Hematology Association 2024 Congress. <Read More> 

Omvoh® (mirikizumab-mrkz) Injection – New Label Expansion – January 15, 2025 – Eli Lilly and Company (NYSE: LLY) announced that the U.S. Food and Drug Administration (FDA) has approved Omvoh® (mirikizumab-mrkz) for the treatment of moderately to severely active Crohn's disease in adults. Omvoh® is now approved in the U.S. for two types of inflammatory bowel disease (IBD), following its October 2023 approval as a first-in-class treatment for moderately to severely active ulcerative colitis (UC) in adults. <Read More> 

Niktimvo™ (axatilimab-csfr) Injection – New Label Expansion – January 15, 2025 – Incyte (NASDAQ:INCY) and Syndax Pharmaceuticals (Nasdaq:SNDX) announced that the U.S. Food and Drug Administration (FDA) has approved Niktimvo™ (axatilimab-csfr) in 9 mg and 22 mg vial sizes. The Companies expect product to be available for order in the U.S. in early February. Niktimvo™ is approved for the treatment of chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg (88.2 lbs). Niktimvo™ is the first and only FDA-approved prescription treatment for chronic GVHD that targets CSF-1R to reduce the drivers of inflammation and fibrosis. <Read More>

Tevimbra® (tislelizumab-jsgr) Injection – New Label Expansion – December 26, 2024 – BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company that intends to change its name to BeOne Medicines Ltd., announced the U.S. Food and Drug Administration (FDA) has approved Tevimbra® (tislelizumab-jsgr), in combination with platinum and fluoropyrimidine-based chemotherapy, for the first-line treatment of unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma (G/GEJ) in adults whose tumors express PD-L1 (≥1). <Read More> 

Zepbound® (tirzepatide) Injection – New Label Expansion – December 20, 2024 – Eli Lilly and Company (NYSE: LLY) announced the U.S. Food and Drug Administration (FDA) approved Zepbound® (tirzepatide) as the first and only prescription medicine for adults with moderate-to-severe obstructive sleep apnea (OSA) and obesity. Zepbound® may help adults with moderate-to-severe obstructive sleep apnea and obesity improve their sleep disorder. It should be used with a reduced-calorie diet and increased physical activity. <Read More>  

Braftovi® (encorafenib) Capsules – New Label Expansion – December 20, 2024 – Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) has approved Braftovi® (encorafenib) in combination with cetuximab (marketed as Erbitux®) and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-approved test. <Read More> 

Trikafta® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) Tablets and Oral Granules – New Label Expansion – December 20, 2024 – Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced the U.S. Food and Drug Administration (FDA) has approved the expanded use of Trikafta® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) for the treatment of people with cystic fibrosis (CF) ages 2 and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation that is responsive to Trikafta® based on clinical and/or in vitro data. In addition, safety information on liver injury and liver failure has been updated from warnings and precautions to a boxed warning. With this approval, 94 additional non-F508del CFTR mutations have been added to the Trikafta® label, and approximately 300 additional people with CF in the U.S. are now eligible for a medicine to treat the underlying cause of their disease for the first time. <Read More> 

Imcivree® (setmelanotide) Injection – New Label Expansion – December 20, 2024 – Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a commercial-stage biopharmaceutical company focused on transforming the lives of patients living with rare neuroendocrine diseases, announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for Imcivree® (setmelanotide) to include children as young as 2 years old. Imcivree® is indicated to reduce excess body weight and maintain weight reduction long-term in patients 2 years of age and older with syndromic or monogenic obesity due to Bardet-Biedl syndrome (BBS) or genetically confirmed pro-opiomelanocortin (POMC), including proprotein convertase subtilisin/kexin type 1 (PCSK1), deficiency or leptin receptor (LEPR) deficiency. <Read More> 

Gemtesa® (vibegron) Tablets – New Label Expansion – December 18, 2024 – Sumitomo Pharma America, Inc. (SMPA) announced that the U.S. Food and Drug Administration (FDA) has approved Gemtesa® (vibegron), a beta-3 (β3) adrenergic receptor agonist, dosed once-daily (75 mg), for the treatment of men with overactive bladder (OAB) symptoms, such as urge urinary incontinence, urgency, and urinary frequency, who are receiving pharmacological therapy for benign prostatic hyperplasia (BPH). This approval marks Gemtesa® as the first and only β3 agonist approved to treat patients living with OAB and being treated for BPH. It is currently available for prescription in the U.S. <Read More> 

Nemluvio® (nemolizumab) for Injection – New Label Expansion – December 13, 2024 – Galderma announced that the United States (U.S.) Food and Drug Administration (FDA) has approved Nemluvio® (nemolizumab) for the treatment of patients 12 years and older with moderate-to-severe atopic dermatitis, in combination with topical corticosteroids (TCS) and/or calcineurin inhibitors (TCI) when the disease is not adequately controlled with topical prescription therapies. This follows the recent U.S. FDA approval of Nemluvio® for subcutaneous injection for the treatment of adults with prurigo nodularis in August 2024. <Read More> 

Vtama® (tapinarof) Cream – New Label Expansion – December 12, 2024 – Organon (NYSE: OGN), a global healthcare company with a mission to improve the health of women throughout their lives, announced that the U.S. Food and Drug Administration (FDA) has approved Vtama® (tapinarof) cream, 1%, an aryl hydrocarbon receptor agonist, for an additional indication of the topical treatment of atopic dermatitis (AD) in adults and pediatric patients 2 years of age and older. Organon received the FDA approval prior to its extended target action date (PDUFA) of March 12, 2025. <Read More> 

Imfinzi® (durvalumab) Injection – New Label Expansion – December 4, 2024 – AstraZeneca’s Imfinzi® (durvalumab) has been approved in the US for the treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. The approval was granted by the Food and Drug Administration (FDA) after securing Priority Review and Breakthrough Therapy Designation. It was based on results from the ADRIATIC Phase III trial which were presented during the Plenary Session of the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and subsequently published in the New England Journal of Medicine. <Read More> 

Acetadote® (acetylcysteine) Injection – New Label Expansion – November 26, 2024 – Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX), a specialty pharmaceutical company focused on delivering high-quality products to improve patient care, announced the FDA has approved a supplemental New Drug Application (sNDA) for its Acetadote® (N-acetylcysteine for injection) product. Acetadote® is an intravenous (IV) formulation of N-acetylcysteine (NAC) indicated to prevent or lessen liver injury after ingestion of potentially toxic quantities of acetaminophen. <Read More> 

Bimzelx® (bimekizumab-bkzx) Injection – New Label Expansion – November 20, 2024 – UCB, a global biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has approved Bimzelx® (bimekizumab-bkzx) for the treatment of adults with moderate to severe hidradenitis suppurativa (HS). Bimekizumab-bkzx is the first and only approved medicine designed to selectively inhibit interleukin 17F (IL-17F) in addition to interleukin 17A (IL-17A). <Read More>  

New Drug Shortage

January 31, 2025

• Epoprostenol Sodium Injection (Discontinuation)

January 30, 2025

• Ramipril Capsule (Discontinuation)

January 28, 2025

• Donepezil Hydrochloride Tablet (Discontinuation)

• Lidocaine Ointment (Discontinuation)

• Lidocaine Ointment (Discontinuation)

• Teriflunomide Tablet (Discontinuation)

January 27, 2025

• Bendamustine Hydrochloride Injection (Discontinuation)

January 24, 2025

• Peginterferon alfa-2a Injection (Currently In Shortage)

Updated Drug Shortage

January 28, 2025

• Amoxapine Tablet (Resolved)

January 27, 2025

• Atropine Sulfate Injection (Currently In Shortage)

• Bupivacaine Hydrochloride Injection (Currently In Shortage)

• Bupivacaine Hydrochloride, Epinephrine Bitartrate Injection (Currently In Shortage)

• Clindamycin Phosphate Injection (Currently In Shortage)

• Dexmedetomidine Hydrochloride Injection (Currently In Shortage)

• Dextrose 50% Injection (Currently In Shortage)

• Dextrose Monohydrate 5% Injection (Currently In Shortage)

• Dobutamine Hydrochloride Injection (Currently In Shortage)

• Dopamine Hydrochloride Injection (Currently In Shortage)

• Epinephrine Bitartrate, Lidocaine Hydrochloride Injection (Currently In Shortage)

• Etomidate Injection (Currently In Shortage)

• Heparin Sodium Injection (Currently In Shortage)

• Hydrocortisone Sodium Succinate Injection (Currently In Shortage)

• Hydromorphone Hydrochloride Injection (Currently In Shortage)

• Ketamine Hydrochloride Injection (Currently In Shortage)

• Lidocaine Hydrochloride Injection (Currently In Shortage)

• Lorazepam Injection (Currently In Shortage)

• Methotrexate Sodium Injection (Currently In Shortage)

• Methylprednisolone Acetate Injection (Currently In Shortage)

• Midazolam Hydrochloride Injection (Currently In Shortage)

• Morphine Sulfate Injection (Currently In Shortage)

• Penicillin G Benzathine Injection (Currently In Shortage)

• Sodium Acetate Injection (Currently In Shortage)

• Sodium Bicarbonate Injection (Currently In Shortage)

• Sodium Chloride 0.9% Injection (Currently In Shortage)

• Sodium Chloride 23.4% Injection (Currently In Shortage)

• Sterile Water Injection (Currently In Shortage)

January 24, 2025

• Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet (Currently In Shortage)

• Dopamine Hydrochloride Injection (Currently In Shortage)

• Etomidate Injection (Currently In Shortage)

• Fentanyl Citrate Injection (Currently In Shortage)

• Hydromorphone Hydrochloride Injection (Currently In Shortage)

• Ketamine Hydrochloride Injection (Currently In Shortage)

• Leucovorin Calcium Injection (Currently In Shortage)

• Lidocaine Hydrochloride Injection (Currently In Shortage)

• Midazolam Hydrochloride Injection (Currently In Shortage)

• Morphine Sulfate Injection (Currently In Shortage)

• Promethazine Hydrochloride Injection (Currently In Shortage)

January 23, 2025

• Amoxapine Tablet (Currently In Shortage)

• Amoxicillin Powder, For Suspension (Currently In Shortage)

• Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet (Currently In Shortage)

• Azacitidine Injection (Currently In Shortage)

• Carboplatin Injection (Currently In Shortage)

• Clonazepam Tablet (Currently In Shortage)

• Hydromorphone Hydrochloride Injection (Currently In Shortage)

• Lisdexamfetamine Dimesylate Capsule (Currently In Shortage)

• Mefloquine Hydrochloride Tablet (Currently In Shortage)

• Methotrexate Sodium Injection (Currently In Shortage)

• Methylphenidate Hydrochloride Tablet, Extended Release (Currently In Shortage)

• Oxazepam Capsule (Currently In Shortage)

• Streptozocin Powder, For Solution (Currently In Shortage)

January 22, 2025

• Dexmedetomidine Hydrochloride Injection (Currently In Shortage)

• Vecuronium Bromide Injection (Resolved)

New Drug Recall and Safety Alerts

Fentanyl Transdermal System 25 mcg/h by Alvogen – New Voluntary Recall – January 31, 2025 - Alvogen, Inc. is voluntarily recalling one lot of Fentanyl Transdermal System 25 mcg/h transdermal patches to the consumer level. The reason for the recall is that there is a potential that patches could be multi-stacked, adhered one on top of the other, in a single product pouch. This transdermal system is manufactured by Kindeva Drug Delivery L.P., Northridge, CA and is distributed by Alvogen, Inc. as a private label distributor. <Read More>

Phenylephrine Hydrochloride Injection, USP, 10 mg/ mL (Pharmacy Bulk Package) by Provepharm Inc. – New Voluntary Recall – January 24, 2025 - Provepharm Inc. is voluntarily recalling lot number 24020027; Expiry Date December 2025 of Phenylephrine hydrochloride Injection, USP, 10 mg/ mL (Pharmacy Bulk Package) at the hospital/institutional level. This recall was initiated based on a customer complaint from a pharmacy after observing a visible black particulate matter found in a single-sealed vial of the product. <Read More> 

New Generic/Biosimilar Approval and Launch

Avtozma® (tocilizumab-anoh) Injection – New Actemra® Biosimilar Approval – January 30, 2025 - Celltrion announced that the U.S. Food and Drug Administration (FDA) has approved Avtozma® (CT-P47, tocilizumab-anoh) in both an intravenous (IV) and subcutaneous (SC) formulation as a biosimilar to Actemra®. Avtozma® is indicated for the treatment of multiple diseases including rheumatoid arthritis (RA), giant cell arteritis (GCA), polyarticular juvenile idiopathic arthritis (pJIA), systemic juvenile idiopathic arthritis (sJIA) and coronavirus disease (COVID-19). <Read More> 

Steqeyma® (ustekinumab-stba) Injection – New Stelara® Biosimilar Approval – December 17, 2024 - Celltrion announced that the U.S. Food and Drug Administration (FDA) has approved Steqeyma® (ustekinumab-stba), a biosimilar to Stelara® (ustekinumab), for subcutaneous injection or intravenous infusion in adult and pediatric patients with plaque psoriasis and psoriatic arthritis, as well as adult patients with Crohn's disease and ulcerative colitis. <Read More>  

Yesintek™ (ustekinumab-kfce) Injection – New Stelara® Biosimilar Approval – November 29, 2024 – Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), announced that the U.S. Food and Drug Administration (FDA) has approved Yesintek™ (ustekinumab-kfce), a biosimilar to the reference product, Stelara® (ustekinumab). <Read More> 

Clinical and Pharmacy News

Guidelines Call for Widespread Type 1 Diabetes Screening in Children – February 4, 2025 – A University of Florida Health physician-scientist led an international team of Type 1 diabetes experts who recently developed new treatment guidelines emphasizing wider screening for the disease among children and adolescents in the general population before symptoms arise. That would include screening the young relatives of those with Type 1 diabetes, such as siblings, because they are at higher genetic risk of developing diabetes. The effort was led by Michael Haller, M.D., chief of pediatric endocrinology in the UF College of Medicine's Department of Pediatrics and a member of the UF Diabetes Institute. The guidelines cover screening, staging, and strategies to preserve beta cell function in children and adolescents with Type 1 diabetes. <Read More> 

Trump Tariffs Will Escalate Costs and Disrupt the Medical Supply Chain, Industry Execs Warn – February 3, 2025 – Double-digit tariffs, if they take effect as proposed, threaten to escalate healthcare costs, disrupt supply chains and create affordability challenges for patients, healthcare executives say. President Donald Trump on Saturday signed executive orders intending to impose sweeping tariffs on the country’s three largest trading partners. The Trump administration imposed 25% tariffs on imports from Canada and Mexico plus a 10% tariff on Chinese imports. <Read More> 

Automated Follow-up Alerts Pharmacists to Cancer Patients’ Needs – January 28, 2025 – Early automated follow-up of cancer patients can help pharmacists more efficiently manage side effects of oral oncolytic medications, according to data presented at the ASHP Midyear 2024 Clinical Meeting & Exhibition, in New Orleans (poster 4-058). To improve adverse event (AE) detection and prevention, a team from Vanderbilt University Medical Center’s Specialty Pharmacy, in Nashville Tenn., sent an electronic early monitoring questionnaire to patients who were starting oral anticancer treatment. The questionnaire, distributed via the patient portal inbox, “resulted in higher [rates of], and faster time to, pharmacists identifying and addressing AEs from newly initiated oral anticancer therapy in patients who responded compared to those who did not respond or were in the usual-care arm,” explained presenter Brooke Looney, PharmD, CSP, the oncology/hematology clinical lead at Vanderbilt. <Read More> 

AI’s Potential in Women’s Health Exciting, Says Gates Foundation Leader – January 21, 2025 – The health disparity between women and men is a pressing global challenge, experts highlighted in a discussion at the World Economic Forum Annual Meeting 2025 in Switzerland. Despite comprising half the global population, women spend 25% more of their lives in poor health compared to men, according to a 2024 report by the World Economic Forum and McKinsey Health Institute. Addressing this gap could not only improve millions of lives, but also add at least $1trn to the global economy annually by 2040, said Anita Zaidi, president of gender equality at the Bill & Melinda Gates Foundation, quoting the report. Innovations in artificial intelligence (AI), digital health tools, and cross-sector collaboration are expected to help bridge this disparity. <Read More> 

Will PBM Reform Save Pharmacies From Closing? – January 15, 2025 – In May 2024, nearly 90% of pharmacies were closed for a day as thousands of pharmacists protested over “over drug shortages, pharmacy closures and fears medications could be sold online, as well as higher pay.” More recently in November 2024, pharmacy owners voted in favor of cutting hours and stopping home deliveries in a protest over funding. Given multiple recent news articles saying that pharmacies are struggling amid problems caused by pharmacy benefit managers (PBMs) , you might not be surprised by these examples. However, these two news stores are not from the U.S. They are from France and the United Kingdom — two countries that do not have the large PBMs that are frequently criticized in America. <Read More> 

Despite Risks and Scant Evidence, Muscle Relaxants Still Used to Treat Chronic Pain – January 14, 2025 – The CDC has guidelines recommending that clinicians avoid using opioids to manage chronic noncancer pain. Now data published in JAMA Network Open indicate that as physicians heed opioid guidelines, prescriptions for skeletal muscle relaxants (SMRs) for chronic pain have risen—despite risks posed by SMRs and a lack of evidence supporting their long-term use (JAMA Network Open 2024;7[9]:e2434835). “This means that, when thinking about using muscle relaxants for chronic pain conditions, we should be vigilant and cautious,” said study author Benjamin J. Oldfield, MD, an internal medicine/pediatric specialist at the Yale School of Medicine, in New Haven, Conn. “As physicians, it may not be the right option to prescribe, and to continue to refill, muscle relaxants for the majority of chronic pain conditions.” <Read More> 

Drugmakers Hiked Prices for Hundreds of Drugs in Early January – January 14, 2025 – Drugmakers raised the list prices on 575 name-brand drugs in just the first two days of the new year, according to drug price research firm 46brooklyn. Drugs for diabetes, HIV, cancer saw price hikes, among others. For years a 10% annual price hike was fairly normal, but they've started coming down in recent years. This year's median price hike so far is only 4%, says Antonio Ciaccia, CEO of 46brooklyn. "While it's early, if that number held throughout the year, that would make it the lowest median price increase in over a decade," says Ciaccia. January is typically a popular time to raise prices on brand name drugs, but companies can raise them throughout the year. There could even be more later this month, he says. <Read More> 

Clearing the Path for New Uses for Generic Drugs – January 9, 2025 – Repurposing generic drugs as new treatments for life-threatening diseases is an exciting yet largely overlooked opportunity due to a lack of market-driven incentives. The low profit margins for generic drugs mean that pharmaceutical companies rarely invest in research, regulatory efforts, and marketing for new uses. Nonprofit organizations and other non-commercial non-manufacturers are increasing efforts to repurpose widely available generic drugs and rapidly expand affordable treatment options for patients. <Read More> 

Pharmacological Treatment in Autism: A Proposal for Guidelines on Common Co-Occurring Psychiatric Symptoms – January 7, 2025 – The prevalence of autism spectrum disorder (ASD) has surged, with an estimated 1 in 36 eight-year-olds in the United States meeting criteria for ASD in 2020. Autistic individuals face elevated rates of co-occurring medical, psychiatric, and behavioral conditions compared to non-autistic individuals. The rising ASD-patient demand is increasingly outpacing the capacity of ASD-specialty clinics, resulting in urgent need for autism-competent providers in general practice settings. This work aims to empower healthcare providers, especially primary care providers (PCPs), with guidelines for the recognition and safe pharmacologic management of common co-occurring psychiatric and behavioral conditions in ASD. <Read More> 

Senate Introduces Bipartisan Bill to Ban Co‑ownership of Pharmacies and Pharmacy Benefits Managers – December 13, 2024 – Senators Elizabeth Warren, D-Mass., and Josh Hawley, R-Mo., introduced in the Senate the Patients Before Monopolies Act (PBM Act), a bill “[t]o prohibit pharmacy benefit managers and pharmacies from being under common ownership, and for other purposes.” The PBM Act would make it unlawful for any person to “own, operate, control, or direct the operation of” any type of pharmacy if that person also “own[s], operate[s], or control[s]” an insurance company or pharmacy benefits manager (PBM). This bill follows nearly a year of heightened government scrutiny of PBMs and allegations of harm resulting from vertical integration and price fixing. If passed, the PBM Act would prevent PBMs and payors from being in a position of control over pharmacies through which they can affect the competitive harms alleged. <Read More> 

Drugmakers and Pharmacists Battle Over Who Gets to Make Obesity Drugs – December 12, 2024 – Ozempic® and similar drugs for Type 2 diabetes and weight loss are in such high demand that the drugmakers have had a hard time keeping up. So compounding pharmacies stepped in to fill the gap, making their own versions of the drugs for more than two years. The compounded versions are especially popular as cheaper alternatives for people whose insurance doesn't cover them. But now the brand name manufacturers are pushing the compounding pharmacies to stop. Novo Nordisk and Eli Lilly are moving to end compounding of their medicines for good. <Read More> 

Pharmacists’ Key Role in the Management of Humira Biosimilars – November 27, 2024 – The introduction of adalimumab (Humira®, AbbVie) biosimilars to the US market in 2023 brought significant changes for providers, patients, and pharmacies. Since its introduction in 2002, Humira has been one of the world’s bestselling drugs for treating inflammatory conditions…Pharmacists have been challenged in managing the complexity of switching patients from the reference product to various biosimilars, including navigating clinical appropriateness, education, insurance, affordability, and several practical hurdles. We aim to provide an update on what is new, what we have learned over the past 12 months, and what we are anticipating in the Humira biosimilar market. <Read More> 

ASTRO Releases Updated Guidelines for Treating Locally Advanced Rectal Cancer – November 25, 2024 – The American Society for Radiation Oncology (ASTRO) issued an updated clinical guideline for physicians who use radiation therapy to treat patients with locally advanced rectal cancer. This update incorporates new data on patient selection and best practices from several practice-changing clinical trials published since the prior guideline was issued in 2020. The updated ASTRO guideline is published in Practical Radiation Oncology. <Read More> 

Top Three Pharmacy Benefit Managers Will Face FTC in Joint Trial for Insulin Rebate Cases – November 20, 2024 – Administrative Law Judge D. Michael Chappell ordered that the country’s largest pharmacy benefit managers (PBMs) have to face the FTC together in an administrative case. The case alleges that the three largest PBMs―Caremark, Express Scripts and OptumRX―used unfair rebate schemes to artificially inflate the price of insulin. In mid-October, the PBMs each moved for separate proceedings, arguing that a consolidated trial could create confusion. The judge held that the factual differences in each of the cases were “minimal and manageable.” Judge Chappell noted that many of the respondents’ arguments regarding confusion of the evidence cited to authority regarding jury trials, but the current case is a bench trial. <Read More> 

Market Trends to Watch for Health Systems and Their Specialty Pharmacies – November 18, 2024 – The overall market for specialty medications has grown dramatically over the past decade, and that trend is expected to continue for at least the next five years. Health systems, patients and pharmacies will experience shifting market dynamics that add challenges to providing specialty care, including price increases, an aging population driving increased utilization and a growing wave of innovative therapies that add new patients to the specialty pool. In response, health systems have sharpened their focus on integrating specialty pharmacy care to now include pharmacy needs within their hospitals to help improve patient outcomes and experiences. <Read More> 

Management of Stage III Non–Small Cell Lung Cancer: ASCO Guideline Rapid Recommendation Update Clinical Insights – November 18, 2024 – Stage III non–small cell lung cancer (NSCLC) is a highly heterogeneous disease with a range of treatment options that have been highlighted in the ASCO guidelines (Figs 1 and 2).1-3 Historically, treatment was largely determined by resectability and nodal extent, without personalization on the basis of molecular subtype. Several recent trials favor molecular profile–guided precision therapy of both resectable and unresectable stage III NSCLC: highlighting the need for guideline-concordant biomarker testing for all patients with stage III NSCLC. In addition, new data address incorporation of perioperative immunotherapy, expanding treatment options for patients with resectable disease. This article provides additional context and insight into common clinical situations encountered by oncologists with a review of recent trials that update the standard of care for both resectable and unresectable stage III NSCLC. <Read More>

340B in the News

New Administration’s Impact on 340B Program: TBD – January 16, 2025 – How could the second Trump administration affect the federal 340B Drug Pricing Program? It’s yet to be determined, according to policy experts. Predicting how the election could ultimately affect the program “is above my pay grade,” joked Maureen Testoni, JD, the president and CEO of 340B Health, a nonprofit organization representing more than 1,500 hospitals and health systems that participate in the 340B program. However, during President-elect Donald Trump’s prior term, “we didn’t see a lot of action on 340B,” she said in a Nov. 19 press briefing. Early on in that administration, Medicare cut its reimbursement for Part B 340B drugs by nearly 30% and redistributed the money through higher payments for nondrug services to all hospitals paid under the Medicare Outpatient Prospective Payment System, Ms. Testoni said. But hospital associations sued over the cuts, and the U.S. Supreme Court overturned them in 2022. <Read More> 

New Drug/Vaccine Approval

Revuforj™ (revumenib) Tablets – New Drug Approval –November 15, 2024 – The Food and Drug Administration approved revumenib (Revuforj™, Syndax Pharmaceuticals, Inc.), a menin inhibitor, for relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation in adult and pediatric patients 1 year and older. Efficacy was evaluated in a single-arm cohort of an open-label, multicenter trial (SNDX-5613-0700, NCT04065399; AUGMENT-101) in 104 adult and pediatric patients (at least 30 days old) with relapsed or refractory (R/R) acute leukemia with a KMT2A translocation. <Read More> Kebilidi™ (eladocagene exuparvovec-tneq) Suspension for Intraputaminal Infusion - New Drug Approval – November 13, 2024 – The U.S. Food and Drug Administration approved Kebilidi™ (eladocagene exuparvovec-tneq), an adeno-associated virus vector-based gene therapy indicated for the treatment of adult and pediatric patients with aromatic L-amino acid decarboxylase (AADC) deficiency. Kebilidi™ is the first FDA-approved gene therapy for treatment of AADC deficiency. <Read More> Aucatzyl™ (obecabtagene autoleucel) Suspension for Intravenous Infusion – New Orphan Drug Approval –November 8, 2024 – The Food and Drug Administration approved obecabtagene autoleucel (Aucatzyl™, Autolus Inc.), a CD19-directed genetically modified autologous T cell immunotherapy, for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Efficacy was evaluated in FELIX (NCT04404660), an open-label, multicenter, single-arm trial that enrolled adults with relapsed or refractory CD19-positive B-cell ALL. Enrolled patients were required to have relapsed following a remission lasting 12 months or less, relapsed or refractory ALL following two or more prior lines of systemic therapy, or disease that was relapsed or refractory 3 or more months after allogeneic stem cell transplantation. <Read More> Danziten™ (nilotinib tartrate) Tablets – New Drug Approval – November 7, 2024 – Azurity Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved Danziten™, the first and only nilotinib with no mealtime restrictions indicated for adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase and adult patients with chronic phase (CP) and acute phase (AP) resistant or intolerant to prior therapy that included imatinib. “Danziten™ offers a new nilotinib treatment option with the equivalent efficacy to Tasigna®, but without the fasting requirements of Tasigna®,” said Richard Blackburn, CEO of Azurity Pharmaceuticals, Inc. <Read More> Emrosi™ (minocycline hydrochloride) Extended-Release Capsules - formerly DFD-29 – New Drug Approval – November 4, 2024 – Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical”), a commercial-stage pharmaceutical company that primarily focuses on selling and marketing U.S. Food and Drug Administration (“FDA”)-approved prescription pharmaceutical products for the treatment of dermatological conditions, announced that the FDA has approved Emrosi™ (Minocycline Hydrochloride Extended Release Capsules, 40 mg), formerly referred to as DFD-29, for the treatment of inflammatory lesions of rosacea in adults. Emrosi™ was developed in collaboration with Dr. Reddy’s Laboratories Ltd. <Read More>

New Indication/Dosage/Formulation Approval

Scemblix® (asciminib) Tablets – New Label Expansion –October 29, 2024 - Novartis announced that Scemblix® (asciminib) was granted accelerated approval by the US Food and Drug Administration (FDA) for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP). The accelerated approval is based on major molecular response rate (MMR) at week 48 from the ASC4FIRST Phase III trial that compared once daily Scemblix® to all other investigator-selected (IS) standard of care (SoC) tyrosine kinase inhibitors (TKIs) (imatinib, nilotinib, dasatinib, and bosutinib). In the study, Scemblix® demonstrated superior MMR rates in both primary endpoints at week 48 vs. IS SoC TKIs and imatinib alone. Continued approval for the newly diagnosed indication may be contingent upon verification and description of clinical benefit from confirmatory evidence. <Read More> RoxyBond™ (oxycodone hydrochloride) Tablets – New Label Expansion – October 29, 2024 – Protega Pharmaceuticals Inc., an innovative specialty pharmaceutical company focused on responsible pain management and the development of novel abuse-deterrent products, announced that the U.S. Food and Drug Administration (FDA) has approved Roxybond™ (oxycodone hydrochloride) immediate-release (IR) CII 10 mg tablet for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Roxybond™ is the first and only FDA-approved abuse-deterrent IR 10 mg oxycodone formulation that is expected to reduce abuse by intranasal and intravenous routes. <Read More> Jylamvo™ (methotrexate) Oral Solution – New Label Expansion – October 29, 2024 – Shorla Oncology (‘Shorla’), a U.S.-Ireland specialty pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has expanded the approval of Jylamvo™ (methotrexate) to include the treatment of pediatric patients with acute lymphoblastic leukemia (ALL) and polyarticular juvenile idiopathic arthritis (pJIA). With this approval, Jylamvo™ is currently the only oral liquid methotrexate on the market approved for both adult and pediatric indications. <Read More>

New Drug Shortage

November 18, 2024

• Metronidazole Injection (Currently In Shortage)

November 13, 2024

• Flurbiprofen Tablet (Discontinuation)

• Isosorbide Mononitrate Tablet (Discontinuation)

November 7, 2024

• Aminocaproic Acid Tablet (Discontinuation)

November 4, 2024

• Albuterol Sulfate Syrup (Discontinuation)

• Hydroxocobalamin Injection (Currently In Shortage)

• Ondansetron Hydrochloride Tablet (Discontinuation)

November 1, 2024

• Sodium Bicarbonate Injection (Currently In Shortage)

Updated Drug Shortage

November 18, 2024

• Technetium Tc-99m Sodium Pertechnetate Generator (Resolved)

November 14, 2024

• Penicillin G Benzathine Injection (Currently In Shortage)

October 18, 2024

• Amino Acid Injection (Currently in Shortage)

• Dextrose Monohydrate Injection (Currently in Shortage)

• Lidocaine Hydrochloride Injection (Currently in Shortage)

• Sterile Water Injection (Currently in Shortage)

November 12, 2024

• Bupivacaine Hydrochloride Injection (Currently In Shortage)

• Bupivacaine Hydrochloride, Epinephrine Bitartrate Injection (Currently In Shortage)

• Dextrose Monohydrate 5% Injection (Currently In Shortage)

• Epinephrine Bitartrate, Lidocaine Hydrochloride Injection (Currently In Shortage)

• Hydrocortisone Sodium Succinate Injection (Currently In Shortage)

• Lidocaine Hydrochloride Injection (Currently In Shortage)

• Methotrexate Sodium Injection (Currently In Shortage)

• Methylprednisolone Acetate Injection (Currently In Shortage)

• Penicillin G Benzathine Injection (Currently In Shortage)

• Sodium Chloride 0.9% Injection (Currently In Shortage)

• Sodium Chloride 23.4% Injection (Currently In Shortage)

• Somatropin Injection (Currently In Shortage)

• Sterile Water Injection (Currently In Shortage)

• Technetium Tc-99m Pyrophosphate Kit Injection (Currently In Shortage)

November 7, 2024

• Lactated Ringers Injection (Currently In Shortage)

November 6, 2024

• Bupivacaine Hydrochloride Injection (Currently In Shortage)

• Dexamethasone Sodium Phosphate Injection (Currently In Shortage)

• Dexmedetomidine Hydrochloride Injection (Currently In Shortage)

• Ketamine Hydrochloride Injection (Currently In Shortage)

• Lidocaine Hydrochloride Injection (Currently In Shortage)

• Lorazepam Injection (Currently In Shortage)

• Ropivacaine Hydrochloride Injection (Currently In Shortage)

New Drug Recall and Safety Alerts

Clonazepam Orally Disintegrating Tablets, USP (C-IV) by Endo - Voluntary Recall Expansion – November 18, 2024 – Endo, Inc. (OTCQX: NDOI) (“Endo”) announced that one of its operating subsidiaries, Endo USA, Inc., is expanding its previously announced voluntary recall of Clonazepam Orally Disintegrating Tablets, USP (C-IV) due to potential product carton strength mislabeling. Specifically, Endo’s ongoing investigation has identified the possibility that the Clonazepam product lots listed below contain a limited number of cartons printed with the incorrect strength and National Drug Code (NDC) code due to an error by a third-party packager. The blister strips and tablets inside the product pack reflect the correct strength for the lot. <Read More>

New Generic/Biosimilar Approval and Launch

No new update.

Clinical and Pharmacy News

Biosimilars: Expanding Options for Inflammatory Disease Treatment – November 15, 2024 – Biologics are mainstays of treatment for many chronic inflammatory conditions. Unfortunately, these drugs often come with high price tags due to the significant costs associated with their development and manufacturing. In recent years, several biosimilar products have been developed, with the goal of increasing competition in the biologics market and reducing the cost of care. The FDA defines a biosimilar product as a biologic medication that is highly similar to and has no clinically meaningful differences from an existing FDA-approved biologic. Biosimilars are approved under an abbreviated licensure pathway created by the Biologics Price Competition and Innovation Act of 2009. <Read More> Future of Medicare Drug Price Negotiations Murky Under Trump – November 15, 2024 – The future of one of President Joe Biden’s key domestic policy achievements — getting Medicare to negotiate drug prices — could either become part of the Biden administration’s legacy, get rolled back by the incoming Congress or be weakened by President-elect Donald Trump’s administration. Trump has remained relatively mum about the drug pricing provisions of the 2022 reconciliation bill and its future appears even murkier now that Republicans will control both the House and Senate. “The Trump campaign articulated no position on drug price negotiation specifically, but congressional Republicans are not fans of this program and introduced legislation to repeal the IRA in its entirety,” said Juliette Cubanski, deputy director of the program on Medicare policy at KFF, a health research organization, referring to the law by its nickname, an abbreviation for the Inflation Reduction Act. <Read More> Amazon Introduces Low Upfront Pricing for a Telehealth Visit With Treatment Plan and Fast, Free Medication for Men's Hair Loss, Eyelash Growth, Anti-Aging, ED, and Motion Sickness for Prime Members – November 14, 2024 – Amazon One Medical Pay-per-visit telehealth service offers customers convenient, high-quality health care for 30+ common conditions (such as pink eye, the flu, or a sinus infection) with on-demand messaging visits (where available) for $29 and video visits for $49 payable by credit card or using a Flexible Spending Account or Health Savings Account card. Following the visit, the clinician sends the customer a personalized treatment plan and prescription (if needed), which customers can fulfill at the pharmacy of their choice. Building on this foundation, Amazon is introducing low, clear upfront pricing for a clinical visit, treatment plan, and fast, free medication delivery for Prime members for a range of common health, beauty, and lifestyle concerns, including anti-aging skincare treatment, men’s hair loss, erectile dysfunction, eyelash growth, and motion sickness. <Read More> AI Poised to Improve Trial Recruitment and Drug Adherence in Specialty Pharmacy – November 14, 2024 – The growing potential roles of artificial intelligence, including large-language models and generative AI, were a major topic of discussion at the 2024 NASP Annual Meeting & Expo, in Nashville, Tenn., with applications in clinical trial recruitment and patient engagement among the many uses cited. In specialty pharmacy, AI can potentially enhance patient engagement by personalizing communication and support, leading to improved adherence and satisfaction, suggested Michael Gannon, the senior director of product management for Loopback Analytics. The technology could facilitate clinical trial development by streamlining patient screening, identifying suitable candidates more efficiently and accelerating the approval of new therapies, Mr. Gannon noted. <Read More> New UTI Guidelines Offers Treatment Clarity, Reveals Gaps in Knowledge – November 12, 2024 - New recommendations from the WikiGuidelines Group offer strategies for the prevention, diagnosis, and management of urinary tract infections (UTIs) in children and adults. While the guideline covers a range of clinical topics, including prophylaxis and antimicrobial stewardship, many key clinical questions remain unanswered due to a lack of high-quality evidence, according to lead author Zachary Nelson, PharmD, MPH, of HealthPartners and Park Nicollet Health Services, St. Louis Park, Minnesota, and colleagues. “This guideline fills a critical gap by providing pragmatic, broadly applicable recommendations tailored for generalist care and systems-based practice,” Nelson and colleagues wrote in JAMA Network Open. <Read More> Off-Label Semaglutide Linked to Deaths, Hospitalizations Calling for Compounding Regulation – November 8, 2024 – Approximately 10 deaths and 100 hospitalizations in the United States have been linked to use of off-brand, compounded semaglutide (Ozempic®; Novo Nordisk), according to the drug’s manufacturer Novo Nordisk. The report comes after the company called on the FDA to prohibit compounding of semaglutide in October 2024, citing significant safety concerns around use of off-brand products. “Semaglutide products belong on these lists due to the complexities associated with their formulations, delivery mechanisms, dosage forms, achievement of bioavailability, compounding processes, and physicochemical and analytical testing,” the company stated. “We request that FDA convene and consult an advisory committee on compounding to discuss the addition of semaglutide products to both DDC [Demonstrable Difficulties for Compounding] Lists and promulgate regulations adding semaglutide products to the DDC Lists.” <Read More> How Pharmacy Benefit Managers Are Harming Patients—and What Policymarkers Can Do About It – November 7, 2024 – Earlier this year, the Federal Trade Commission (FTC) announced that it had begun taking legal action against the three largest pharmacy benefit managers (PBMs), the third-party companies that manage prescription drug benefits for health insurance companies and employers. In its filing, the FTC accused these PBMs of abusing their market power to inflate the price of insulin and make it harder for patients to afford it. The three PBMs named by the FTC—Caremark Rx, Express Scripts (ESI), and OptumRx—control about 80 percent of the market. The FTC’s action responds to a very real threat: around 30 percent of the U.S. population struggles to afford prescription drugs, and the burden of unaffordable prescription drug prices does not fall equally. <Read More> Study Finds GLP-1s Safe and Effective for Managing Obesity in Patients with IBD – November 6, 2024 – Glucagon-like peptide-1 receptor agonists are well tolerated and effective for weight loss in patients with inflammatory bowel disease, with a safety profile similar to that observed in the general population prescribed these medications, according to data presented at DDW 2024 by a team of researchers from the University of Pennsylvania. Researchers also saw a reduction in C-reactive protein (CRP) levels, although they said more data are needed to fully explain this change. Experts said this study is particularly relevant given that obesity now affects 15% to 40% of people with IBD (Nat Rev Gastroenterol Hepatol 2017;14[2]:110-121). <Read More>

340B in the News

California Votes to Impose 340B Spending Restrictions on Targeted 340B Providers – November 14, 2024 – California is poised to pass a ballot measure aimed at imposing 340B spending restrictions for certain healthcare entities participating in the 340B Program who have historically engaged in spending that is not directly related to patient care and have also owned or operated multifamily dwellings with significant safety issues. <Read More> J&J Sues Federal Government for Halting 340B Rebate Plan – November 13, 2024 – Johnson & Johnson is suing the Biden administration for blocking a controversial change to how the pharmaceutical company divvies out drug discounts to hospitals in a federal savings program. This summer, J&J unveiled a plan to give hospitals after-the-fact rebates for two medications in the program, called 340B, instead of upfront discounts, but paused implementation following threats of government sanctions. The lawsuit filed Tuesday in a district court seeks a ruling finding J&J’s plan legal and allowing the drugmaker to roll out the model. <Read More>

New Drug/Vaccine Approval

Orlynvah™ (sulopenem etzadroxil and probenecid) Tablets – New Drug Approval – October 25, 2024 – The U.S. Food and Drug Administration has approved Orlynvah™ (sulopenem etzadroxil and probenecid) oral tablets for the treatment of uncomplicated urinary tract infection(s) (uUTI) caused by certain bacteria (Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis) in adult women who have limited or no alternative oral antibacterial treatment options. Orlynvah™ is not indicated for the primary or step-down treatment of complicated UTI (cUTI) or complicated intra-abdominal infections (cIAI). Orlynvah™ is taken as one oral tablet twice daily for 5 days. <Read More> Vyloy™ (zolbetuximab-clzb) Injection – New Drug Approval – October 18, 2024 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") announced that the U.S. Food and Drug Administration (FDA) has approved Vyloy™ (zolbetuximab-clzb) in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive as determined by an FDA-approved test. Vyloy™ is the first and only CLDN18.2-targeted therapy approved in the U.S. <Read More> Vyalev™ (foscarbidopa and foslevodopa) Injection – New Drug Approval –October 16, 2024 – AbbVie (NYSE: ABBV) announced that the U.S. Food and Drug Administration (FDA) has approved Vyalev™ (foscarbidopa and foslevodopa) as the first and only subcutaneous 24-hour infusion of levodopa-based therapy for the treatment of motor fluctuations in adults with advanced Parkinson's disease (PD)…The approval was supported by the pivotal Phase 3, 12-week study evaluating the efficacy of continuous subcutaneous infusion of Vyalev™  in adult patients with advanced PD compared to oral immediate-release carbidopa/levodopa (CD/LD IR), along with a 52-week, open-label study which evaluated the long-term safety and efficacy of Vyalev™. <Read More> Hympavzi™ (marstacimab-hncq) Injection – New Drug Approval – October 11, 2024 – Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) has approved Hympavzi™ (marstacimab-hncq) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and pediatric patients 12 years of age and older with hemophilia A (congenital factor VIII deficiency) without factor VIII (FVIII) inhibitors, or hemophilia B (congenital factor IX deficiency) without factor IX (FIX) inhibitors. <Read More> Itovebi™ (inavolisib) Tablets – New Drug Approval – October 10, 2024 – The Food and Drug Administration approved inavolisib (Itovebi™, Genentech, Inc.) with palbociclib and fulvestrant for adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth-factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy. FDA also approved the FoundationOne® Liquid CDx assay as a companion diagnostic device to identify patients with breast cancer for treatment with inavolisib with palbociclib and fulvestrant. <Read More>

New Indication/Dosage/Formulation Approval

Abrysvo® (respiratory syncytial virus vaccine) Injection – New Label Expansion – October 22, 2024 – Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) has approved Abrysvo® (Respiratory Syncytial Virus Vaccine), the company’s bivalent RSV prefusion F (RSVpreF) vaccine, for the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV. Abrysvo® now offers the broadest RSV vaccine indication for adults, which previously included those 60 years and older. Additionally, it remains the only RSV immunization approved for pregnant individuals at 32 through 36 weeks of gestation to protect infants from birth up to 6 months of age. <Read More> Botox® Cosmetic (onabotulinumtoxinA) for Injection – New Label Expansion – October 18, 2024 – Allergan Aesthetics, an AbbVie company (NYSE: ABBV), announced the U.S. FDA approval of Botox® Cosmetic for temporary improvement in the appearance of moderate to severe vertical bands connecting the jaw and neck (platysma bands) in adults. Botox® Cosmetic is the first and only product with four aesthetic indication areas: forehead lines, frown lines, crow's feet lines, and now platysma bands, making it the first product of its kind to go beyond the face. <Read More> Lumryz™ (sodium oxybate) Granules for Extended-Release Oral Suspension – New Label Expansion – October 16, 2024 – Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental new drug application (sNDA) for Lumryz™ for the treatment of cataplexy or EDS in patients 7 years of age and older with narcolepsy. <Read More> Bimzelx® (bimekizumab-bkzx) Injection – New Label Expansion – October 11, 2024 – UCB, a global biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has approved a 2 mL pre-filled syringe and pre-filled autoinjector, each containing 320 mg of Bimzelx® (bimekizumab-bkzx). These new device presentations add to the currently available 1 mL administration options, each containing 160 mg of bimekizumab-bkzx, and mean that patients requiring a 320 mg dose of bimekizumab-bkzx will have options for single-injection administration. “Our goal with these single-injection regimens is to strengthen and expand administration options, increase convenience and enhance the individual patient experience,” said Emmanuel Caeymaex, Executive Vice President, Head of Patient Impact, Chief Commercial Officer, UCB. <Read More> Opdivo® (nivolumab) Injection – New Label Expansion – October 3, 2024 – Bristol Myers Squibb (NYSE: BMY) announced that the U.S. Food and Drug Administration (FDA) approved Opdivo® (nivolumab) for the treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements, for neoadjuvant treatment, in combination with platinum-doublet chemotherapy, followed by single-agent Opdivo® as adjuvant treatment after surgery – otherwise referred to as perioperative therapy, which is used before and after surgery.  The approval is based on results from the CheckMate-77T trial, the company’s second positive Phase 3 randomized trial with an immunotherapy-based combination for the treatment of resectable NSCLC. Opdivo® is now the only PD-1 inhibitor to demonstrate statistically significant and clinically meaningful benefits in this disease versus chemotherapy in both a neoadjuvant-only regimen and as part of a perioperative regimen. <Read More>

New Drug Shortage

October 28, 2024

• Exenatide Synthetic Injectable Suspension, Extended Release (Discontinuation)

October 25, 2024

• Exenatide Synthetic Injection (Discontinuation)

October 24, 2024

• Amoxapine Tablet (Currently in Shortage)

October 22, 2024

• Atomoxetine Hydrochloride Capsule (Discontinuation)

• Telmisartan Tablet (Discontinuation)

October 21, 2024

• Technetium Tc-99m Sodium Pertechnetate Generator (Currently in Shortage)

Updated Drug Shortage

October 24, 2024

• Cisplatin Injection (Resolved)

• Epinephrine Injection, Syringes (Resolved)

October 22, 2024

• Peritoneal Dialysis Solution (Currently in Shortage)

October 18, 2024

• Amino Acid Injection (Currently in Shortage)

• Dextrose Monohydrate Injection (Currently in Shortage)

• Lidocaine Hydrochloride Injection (Currently in Shortage)

• Sterile Water Injection (Currently in Shortage)

October 16, 2024

• Azacitidine Injection (Currently in Shortage)

• Dexmedetomidine Hydrochloride Injection (Currently in Shortage)

• Ketorolac Tromethamine Injection (Currently in Shortage)

• Lactated Ringers Injection (Currently in Shortage)

• Methotrexate Sodium Injection (Currently in Shortage)

October 15, 2024

• Amoxapine Tablet (Currently in Shortage)

• Amoxicillin Powder, For Suspension (Currently in Shortage)

• Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet (Currently in Shortage)

• Azacitidine Injection (Currently in Shortage)

• Chloroprocaine Hydrochloride Injection (Currently in Shortage)

• Clonazepam Tablet (Currently in Shortage)

• Dexamethasone Sodium Phosphate Injection (Currently in Shortage)

• Dextrose Monohydrate Injection (Currently in Shortage)

• Hydromorphone Hydrochloride Injection (Currently in Shortage)

• Isoniazid Tablet (Currently in Shortage)

• Lidocaine Hydrochloride Injection (Currently in Shortage)

• Lisdexamfetamine Dimesylate Capsule (Currently in Shortage)

• Mefloquine Hydrochloride Tablet (Currently in Shortage)

• Methotrexate Sodium Injection (Currently in Shortage)

• Methylphenidate Hydrochloride Tablet, Extended Release (Currently in Shortage)

• Midazolam Hydrochloride Injection (Currently in Shortage)

• Sodium Chloride 0.9% Injection (Currently in Shortage)

• Sterile Water Injection (Currently in Shortage)

• Vinblastine Sulfate Injection (Resolved)

New Drug Recall and Safety Alerts

Ascorbic Acid Solution for Injection (Preservative Free, Non-Corn) 500mg/mL by Staska Pharmaceuticals, Inc. – New Voluntary Recall – October 16, 2024 – Staska Pharmaceuticals, Inc. is voluntarily recalling 1 lot of Ascorbic Acid Solution for Injection (Preservative Free, Non-Corn) 500mg/mL, 50mL vials to the user level. This is due to the presence of glass particulates in one lot of vials used in the production of this batch. <Read More>

New Generic/Biosimilar Approval and Launch

Imuldosa™ (ustekinumab-srlf) Injection – New Biosimilar Approval for Stelara® – October 10, 2024 – Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, Ltd., focused on the development of oncology, immunology, and critical care therapies, announced that the U.S. Food and Drug Administration (FDA) has approved Imuldosa™ (ustekinumab-srlf), a biosimilar to Stelara® (ustekinumab), for the treatment of chronic inflammatory conditions, including psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. The FDA approved Imuldosa™ for all indications of its reference medicine, Stelara®. <Read More>

Clinical and Pharmacy News

Centene Sues CMS Over Medicare Advantage Star Ratings – October 24, 2024 – Centene has joined the list of insurers that are suing the Centers for Medicare and Medicaid Services over the 2025 Medicare Advantage Star Ratings. Centene of Missouri and 10 affiliated plans such as Meridian Health Plan of Michigan and several Wellcare plans filed the lawsuit Tuesday in federal court in Missouri. Centene is suing over one of the measures used by CMS to calculate star ratings, the success rate of calls that CMS interviewers, called secret shoppers, make to the plan through text-to-voice teletypewriter (TTY) services. Secret Shoppers use internet protocol enabled text-to-voice-teletypewriter services (IPTTY) to make these calls. A score is based on the number of successful calls that connect to the plan's call center compared to the number of calls made, the complaint said. CMS held a single call against Centene, the lawsuit said. This call never reached the call center. <Read More> Independent Pharmacies Face Potential Closure Without Stricter PBM Regulation – October 24, 2024 – Several local independent pharmacies warn they may go out of business unless there’s more regulation on pharmacy benefit managers, or PBMs, who play a pivotal role in drug pricing. Lawmakers recently introduced House Bill 9096, also known as the “Pharmacists Fight Back Act,” in the House. The proposed legislation aims to make the prescription drug system more equitable for pharmacies and patients. “Prescription drug prices have gone up, and they have passed those prices along to the patients at the pharmacy counter,” said Trent McLemore, director of pharmacy at Star Discount Pharmacy. He points to PBMs as the main issue. PBMs act as intermediaries between insurance companies and pharmacies, often steering patients toward their own mail-order services for more profitable prescriptions. <Read More> PBM Math: Big Chains are Paid $23.55 to Fill a Blood Pressure Rx. Small Drugstores? $1.51 – October 24, 2024 – While customers at Adams Family Pharmacy picked up their prescriptions on a hot summer day, some stopped in for coffee, ice cream, homemade cake, or cookies. It wasn’t a bake sale, but the sweets bring extra revenue as pharmacist and co-owner Nikki Bryant works to achieve profitability at her business on the town square. Bryant said she is doing all she can to bolster it against a powerful force that threatens her and other independent pharmacists: the middlemen who manage virtually all prescriptions written in the U.S., called pharmacy benefit managers, or PBMs. Serving as brokers among drugmakers, pharmacies, and health insurers, these health care entities have drawn scrutiny from Congress, the Federal Trade Commission, and state legislatures for their role in the increase in drug prices. Bryant and other independent pharmacists say PBMs not only create higher costs but also make it harder for patients to access medications. <Read More> Novo Nordisk Asks US to Stop Compounding Pharmacies From Making Weight-Loss Drug Copies – October 23, 2024 – Novo Nordisk (NOVOb.CO), asked the U.S. Food and Drug Administration to ban compounding pharmacies from making copycat versions of its popular weight-loss and diabetes drugs, which it said were too complex for those manufacturers to produce safely. U.S. regulations allow compounders to copy brand-name medicines that are in short supply by combining, mixing or altering drug ingredients to meet demand. Novo's Wegovy® and diabetes drug Ozempic®, both known chemically as semaglutide, have been in shortage in the U.S. for much of this year. In its submission, the Danish drugmaker asked the FDA to consider placing semaglutide on a list of drugs that, even though they are in shortage, are too complex to be copied. Novo said compounded versions of Wegovy® are being sold in incorrect dosage strengths, have been found to contain unknown impurities, and have been linked to nearly 400 serious adverse events since 2018. <Read More> Pharmacy Comes Full Circle as Site of Care – October 23, 2024 – Historically, pharmacists were community-based healthcare providers who made and prescribed medicines. With rapid shifts in healthcare occurring in the 20th and 21st centuries, pharmacies once again should be considered as low-cost medical homes for patients, panelists said in a presentation at Asembia’s AXS24 Summit, in Las Vegas. Three of them spoke with Specialty Pharmacy Continuum after the meeting…However, payment for pharmacist services is still a significant barrier faced by the industry, panelists said. “We have to reach the inflection point where we have enough payors willing to pay pharmacists for these services, in spite of the fact that [the Centers for Medicare & Medicaid Services] has not yet recognized us as providers,” said Alexandra Broadus, PharmD, the senior director of clinical pharmacy strategy at Walgreens. <Read More> Oscar Health Expands ACA Presence and Chronic Condition Plans – October 23, 2024 – Healthcare insurtech Oscar Health will be expanding its presence on the Affordable Care Act marketplace in 2025 and is introducing new plans for people with multiple chronic conditions. The company will expand into 405 markets across 18 states next year, it said. Oscar is launching a multi-condition plan for members with diabetes, pulmonary and cardiovascular disease – three common conditions impacting ACA members, it said. Internal research showed managing those conditions can lower costs by up to 25%. Benefits of the plan include no out-of-pocket costs for cardiologists, pulmonologists, endocrinologists, screenings and labs, primary and behavioral care, and medications. Members can enroll in Oscar's single-condition plans, Diabetes Care and Breathe Easy, in select states. <Read More> FDA Updates Biosimilars Action Plan – October 21, 2024 – With the April approval of trastuzumab-strf (Hercessi™, Accord BioPharma), a HER2/neu receptor antagonist that is a biosimilar for Herceptin® (Genentech)—the FDA marked its approval of 50 biosimilar agents. At the same time, the agency also updated its Biosimilars Action Plan (BAP), first released in 2018, to reinforce its strategy to further expand biosimilar product availability and use. “The [updated] BAP describes the agency’s high-level vision to encourage innovation and competition for biologics and to facilitate the development of safe and effective biosimilar and interchangeable biosimilar products at potentially lower costs for patients,” said Sarah Yim, MD, the director of the FDA’s Office of Therapeutic Biologics and Biosimilars. <Read More> Reproductive Care, Including Abortion, Facing Challenges – October 17, 2024 – Reproductive care is becoming more difficult for women to access, and that's especially true in the case of abortion care, finds a new Wisp survey. Over the last decade, about 20% of women tried to access abortion services, but a third of them faced barriers ranging from cost to lack of insurance, and legal restrictions in some states. The survey is a snapshot of reproductive care in the aftermath of the 2022 Supreme Court decision to overturn Roe v. Wade, the legal precedent that for decades had enshrined the right to abortion. In a 5-4 vote the Justices ruled that the Constitution does not confer a right to abortion, and that regulating abortion should be reverted back to the states. <Read More> Quantifying the Cost of Specialty Pharmacist Interventions for 'Outside' Prescriptions – October 15, 2024 – Interventions performed by health-system specialty pharmacists (HSSPs) for patients who don’t fill their specialty prescriptions with the system—due to either payor or manufacturer restrictions, or because the patient chooses an outside pharmacy—cost thousands of dollars per month, according to a new study from Vanderbilt University Medical Center (VUMC). “Payor and manufacturer lockouts limit HSSPs’ ability to dispense specialty medications to health-system patients, often limiting patient visibility and increasing workload,” said Autumn Zuckerman, PharmD, VUMC’s director of specialty pharmacy. “We wanted to document the cost of interventions that our pharmacists perform for patients we can’t bill for.” The study focused on patients filling their prescriptions at non-Vanderbilt pharmacies from neurology, hepatology and adult GI/IBD (inflammatory bowel disease) clinics between Jan. 1 and May 31, 2023. <Read More>

340B in the News

No new update.

New Drug/Vaccine Approval

Flyrcado™ (flurpiridaz F 18) Injection – New Drug Approval – September 27, 2024 – GE HealthCare (Nasdaq: GEHC) announced that the U.S. Food and Drug Administration (FDA) has granted approval of Flyrcado™ (flurpiridaz F 18) injection, a first of its kind positron emission tomography myocardial perfusion imaging (PET MPI) agent, for the detection of coronary artery disease (CAD). Indicated for patients with known or suspected CAD, Flyrcado™ delivers higher diagnostic efficacy compared to single-photon emission computed tomography (SPECT) MPI, the predominant procedure used in nuclear cardiology today. <Read More> Cobenfy™ (xanomeline and trospium chloride) Capsules – New Drug Approval – September 26, 2024 – Bristol Myers Squibb (NYSE: BMY) announced that the U.S. Food and Drug Administration (FDA) has approved Cobenfy™ (xanomeline and trospium chloride), an oral medication for the treatment of schizophrenia in adults. Cobenfy™ represents the first new class of medicine in several decades and introduces a fundamentally new approach to treating schizophrenia by selectively targeting M 1 and M 4 receptors in the brain without blocking D 2 receptors. <Read More> Aqneursa™ (levacetylleucine) Granules for Oral Suspension – New Drug Approval – September 24, 2024 - The U.S. Food and Drug Administration approved Aqneursa™ (levacetylleucine) for the treatment of neurological symptoms associated with Niemann-Pick disease type C (NPC) in adults and pediatric patients weighing at least 15 kilograms. <Read More> Miplyffa™ (arimoclomol) Capsules – New Drug Approval – September 20, 2024 - The U.S. Food and Drug Administration approved Miplyffa™ (arimoclomol), an oral medication for the treatment of Niemann-Pick disease, type C (NPC). Miplyffa™, in combination with the enzyme inhibitor miglustat, is approved to treat neurological symptoms associated with NPC in adults and children 2 years of age and older. Miplyffa™ is the first drug approved by the FDA to treat NPC. <Read More> Ebglyss™  (lebrikizumab-lbkz) injection – New Drug Approval – September 13, 2024 - Eli Lilly and Company (NYSE: LLY) announced the U.S. Food and Drug Administration (FDA) approved Ebglyss™ (lebrikizumab-lbkz), a targeted IL-13 inhibitor, for the treatment of adults and children 12 years of age and older who weigh at least 88 pounds (40 kg) with moderate-to-severe atopic dermatitis (eczema) that is not well controlled despite treatment with topical prescription therapies. Eczema inflammation under the skin can lead to symptoms seen and felt on the outside. Ebglyss™ works by targeting eczema inflammation throughout the body that can lead to dry, itchy and irritated skin. <Read More> Ocrevus Zunovo™ (ocrelizumab & hyaluronidase-ocsq) Injection – New Drug Approval – September 13, 2024 - Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced that the United States Food and Drug Administration (U.S. FDA) has approved Ocrevus Zunovo™ (ocrelizumab & hyaluronidase-ocsq) for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). Ocrevus Zunovo™ is the first and only twice-a-year, healthcare professional (HCP)-administered approximately 10-minute subcutaneous (SC) injection approved for both these forms of multiple sclerosis, giving people living with MS more treatment options. <Read More> Tecentriq Hybreza™ (atezolizumab and hyaluronidase-tqjs) Injection - New Drug Approval – September 12, 2024 - The Food and Drug Administration approved atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza™, Genentech, Inc.) for subcutaneous injection for all the adult indications as the intravenous formulation of atezolizumab (Tecentriq®, Genentech, Inc.), including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), hepatocellular carcinoma (HCC), melanoma, and alveolar soft part sarcoma (ASPS). See the prescribing information for the specific indications. <Read More>

New Indication/Dosage/Formulation Approval

Dupixent® (dupilumab) Injection – New Label Expansion – September 27, 2024 - The US Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) as an add-on maintenance treatment of adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. Dupixent® is the first biologic medicine approved in the US to treat these patients. <Read More> Retevmo® (selpercatinib) Capsules and Tablets – New Label Expansion – September 27, 2024 - The Food and Drug Administration granted traditional approval to selpercatinib (Retevmo®, Eli Lilly and Company) for adult and pediatric patients 2 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy. Selpercatinib received accelerated approval for this indication for patients 12 years of age and older in 2020. <Read More> Tagrisso® (osimertinib) Tablets – New Label Expansion – September 25, 2024 - AstraZeneca’s Tagrisso® (osimertinib)​ has been approved in the US for the treatment of adult patients with unresectable, Stage III epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy (CRT). Tagrisso® is indicated for patients with exon 19 deletions or exon 21 (L858R) mutations, as detected by an FDA-approved test. <Read More> Bimzelx® (bimekizumab-bkzx) Injection – New Label Expansion – September 20, 2024 - UCB, a global biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has approved Bimzelx® (bimekizumab-bkzx) for the treatment of adults with active psoriatic arthritis (PsA), adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation, and adults with active ankylosing spondylitis (AS). Bimekizumab-bkzx is the first approved treatment for these three indications that is designed to selectively inhibit two key cytokines driving inflammatory processes – interleukin 17A (IL-17A) and interleukin 17F (IL-17F). These newly approved indications follow the first U.S. approval for Bimzelx® in October 2023 for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. <Read More> Sarclisa® (isatuximab-irfc) Injection – New Label Expansion – September 20, 2024 - The US Food and Drug Administration (FDA) has approved Sarclisa® (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) as a first line treatment option for adult patients with newly diagnosed multiple myeloma (NDMM) who are not eligible for autologous stem cell transplant (ASCT). Sarclisa® is the first anti-CD38 therapy in combination with standard-of-care VRd to significantly reduce disease progression or death (by 40%) compared to VRd alone for patients with NDMM not eligible for transplant. <Read More> FluMist® (Influenza Virus Vaccine, Live, Intranasal) Nasal Spray – New Label Expansion – September 20, 2024 - FluMist® has been approved in the US as the only self-administered influenza vaccine. FluMist®, a needle-free nasal spray, was approved to be self-administered by adults up to 49 years of age or administered by a parent/caregiver to individuals 2-17 years of age. The approval by the US Food and Drug Administration (FDA) was based on a comprehensive submission, which included results from a usability study demonstrating that individuals over 18 years of age could self-administer or administer FluMist® to eligible individuals 2-49 years of age. <Read More> Rybrevant® (amivantamab-vmjw) Injection – New Label Expansion – September 19, 2024 - Johnson & Johnson (NYSE: JNJ) announced that following a priority review, the U.S. Food and Drug Administration (FDA) has approved Rybrevant® (amivantamab-vmjw) in combination with chemotherapy (carboplatin-pemetrexed) for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations as detected by an FDA-approved test.1 This FDA action converts the May 2021 accelerated approval of Rybrevant® to a full approval based on the confirmatory Phase 3 PAPILLON study. <Read More> Fasenra® (benralizumab) Injection – New Label Expansion – September 17, 2024 - AstraZeneca’s Fasenra® (benralizumab) has been approved in the US for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA). EGPA is a rare, immune-mediated vasculitis that can result in damage to multiple organs, and without treatment, can be fatal. The approval by the US Food and Drug Administration (FDA) was based on positive results from the MANDARA Phase III trial published in The New England Journal of Medicine, which compared the efficacy and safety of Fasenra® to the only approved EGPA treatment, mepolizumab, in patients with relapsing or refractory EGPA. <Read More> Kisqali® (ribociclib) Tablets – New Label Expansion – September 17, 2024 - Novartis announced that the US Food and Drug Administration (FDA) has approved Kisqali® (ribociclib) in combination with an aromatase inhibitor (AI) for the adjuvant treatment of people with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) stage II and III early breast cancer (EBC) at high risk of recurrence, including those with node-negative (N0) disease. <Read More> Keytruda® (pembrolizumab) for Injection – New Label Expansion – September 17, 2024 – Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced the U.S. Food and Drug Administration (FDA) has approved Keytruda®, Merck’s anti-PD-1 therapy, in combination with pemetrexed and platinum chemotherapy, for the first-line treatment of adult patients with unresectable advanced or metastatic malignant pleural mesothelioma (MPM). <Read More> Dupixent® (dupilumab) Injection – New Label Expansion – September 12, 2024 – Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi announced that the U.S. Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) as an add-on maintenance treatment for adolescent patients aged 12 to 17 years with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). This approval expands the initial June 2019 FDA approval in CRSwNP for patients aged 18 years and older. The FDA evaluated Dupixent® for this expanded indication under Priority Review, which is reserved for medicines that represent potentially significant improvements in efficacy or safety in treating serious conditions. <Read More> Tremfya® (guselkumab) Injection – New Label Expansion – September 11, 2024 - Johnson & Johnson (NYSE: JNJ) announced that the U.S. Food and Drug Administration (FDA) has approved Tremfya® (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC), a chronic disease of the large intestine in which the lining of the colon becomes inflamed. Tremfya® is the first and only approved fully-human, dual-acting monoclonal antibody that blocks IL-23 while also binding to CD64, a receptor on cells that produce IL-23. IL-23 is a cytokine secreted by activated monocyte/macrophages and dendritic cells that is known to be a driver of immune-mediated diseases including UC. <Read More>  Filspari® (sparsentan) Tablets - New Label Expansion – September 5, 2024 - Travere Therapeutics, Inc., (Nasdaq: TVTX) announced that the U.S. Food and Drug Administration (FDA) has granted full approval to Filspari® (sparsentan) to slow kidney function decline in adults with primary IgAN who are at risk of disease progression. Filspari® was granted accelerated approval in February 2023 based on the surrogate marker of proteinuria. Full approval is based on positive long-term confirmatory results from the PROTECT Study demonstrating that FILSPARI significantly slowed kidney function decline over two years compared to irbesartan. <Read More>

New Drug Shortage

September 30, 2024

• Irinotecan Hydrochloride Injection (Discontinuation)

September 27, 2024

• Fluconazole Tablet (Discontinuation)

• Voxelotor Tablet (Discontinuation)

September 26, 2024

• Caspofungin Acetate Injection (Discontinuation)

September 25, 2024

• Testosterone Cypionate Injection (Discontinuation)

September 24, 2024

• Fentanyl Citrate Tablet (Discontinuation)

• Fentanyl Citrate Troche/Lozenge (Discontinuation)

• Indium In-111 Chloride Injection (Discontinuation)

Updated Drug Shortage

October 01, 2024

• Sodium Chloride 0.9% Irrigation (Currently In Shortage)

• Sterile Water Irrigant (Currently In Shortage)

September 27, 2024

• Bupivacaine Hydrochloride, Epinephrine Bitartrate Injection (Currently In Shortage)

• Dobutamine Hydrochloride Injection (Currently In Shortage)

• Epinephrine Bitartrate, Lidocaine Hydrochloride Injection (Currently In Shortage)

• Heparin Sodium Injection (Currently In Shortage)

• Hydrocortisone Sodium Succinate Injection (Currently In Shortage)

• Hydromorphone Hydrochloride Injection (Currently In Shortage)

• Lidocaine Hydrochloride Injection (Currently In Shortage)

• Lorazepam Injection (Currently In Shortage)

• Methotrexate Sodium Injection (Currently In Shortage)

• Methylprednisolone Acetate Injection (Currently In Shortage)

• Morphine Sulfate Injection (Currently In Shortage)

• Penicillin G Benzathine Injection (Currently In Shortage)

• Sodium Bicarbonate Injection (Currently In Shortage)

• Sodium Chloride 0.9% Injection (Currently In Shortage)

• Sodium Chloride 23.4% Injection (Currently In Shortage)

September 25, 2024

• Lidocaine Hydrochloride Injection (Currently In Shortage)

• Lorazepam Injection (Currently In Shortage)

• Methotrexate Sodium Injection (Currently In Shortage)

• Methylprednisolone Acetate Injection (Currently In Shortage)

• Promethazine Hydrochloride Injection (Currently In Shortage)

September 24, 2024

• Penicillin G Benzathine Injection (Currently In Shortage)

September 20, 2024

• Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet (Currently In Shortage)

New Drug Recall and Safety Alerts

Veklury® (Remdesivir) for Injection 100 mg/vial by Gilead – New Voluntary Recall – September 20, 2024 - Gilead Sciences, Inc. (Nasdaq: GILD) announced it is issuing a voluntary recall of one lot of Veklury® (remdesivir) for Injection 100 mg/vial, to the consumer level. Gilead received a customer complaint and confirmed the presence of a glass particle in the vial during the company's investigation. <Read More> Atovaquone Oral Suspension by Bionpharma Inc. – New Voluntary Recall – September 17, 2024 - Bionpharma Inc. is voluntarily recalling (1) single Batch (2310083) of Atovaquone Oral Suspension, 750mg per mL to the consumer level. The product was manufactured by CoreRx, Inc. in Clearwater, FL and distributed by Bionpharma Inc. The product was found to be contaminated with Cohnella bacteria. <Read More>

New Generic/Biosimilar Approval and Launch

Otulfi™ (ustekinumab-aauz) Injection – New Biosimilar Approval for Stelara® – September 27, 2024 - Fresenius Kabi, an operating company of Fresenius, specializing in biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs for critical and chronic conditions, and Formycon AG, a leading, independent developer of high-quality biosimilars, announced that the European Commission (EC) granted marketing authorization for its ustekinumab biosimilar candidate, indicated for the treatment of several serious inflammatory diseases. <Read More> Pavblu™ (aflibercept-ayyh) Injection – New Biosimilar Approval for Eylea® – August 23, 2024 - We have approved your BLA for Pavblu™ (aflibercept-ayyh) effective this date. You are hereby authorized to introduce or deliver for introduction into interstate commerce, Pavblu™ under your existing Department of Health and Human Services U.S. License No. 1080. Pavblu™ is indicated for neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), and diabetic retinopathy (DR). <Read More>

Clinical and Pharmacy News

Pfizer to Pull Sickle Cell Drug From Market, Shut Down Trials – September 26, 2024 – Pfizer is pulling the sickle cell disease drug Oxbryta® off the market and ending clinical trials of the medicine around the world due to safety concerns. Clinical data “now indicates that the overall benefit of Oxbryta® no longer outweighs the risk,” Pfizer said Wednesday. The company said data show an imbalance of deaths and vaso-occlusive crises, the excruciating episodes of pain that patients with sickle cell disease experience. The company said it notified regulatory authorities of the results. <Read More> Managing the High Cost of Specialty Medication – September 20, 2024 – Employers and health plans are concerned about managing high-ticket items such as cell and gene therapies, and interested in potential savings from biosimilars, according to a large managed care survey presented at Asembia’s AXS24 Summit, in Las Vegas. The survey, detailed in the Trends in Specialty Drug Benefits Report by the Pharmaceutical Strategies Group (PSG), sampled 185 benefits leaders representing employers, health plans and unions/Taft-Hartley plans covering an estimated 86.6 million lives. Employers made up 68% of respondents and health plans made up 28%. The majority of respondents (73%) used one of the three largest pharmacy benefit managers (PBMs): CVS, Express Scripts or OptumRx. <Read More> FTC Sues Major Pharmacy Benefit Managers Over Insulin Prices – September 20, 2024 – The Federal Trade Commission has filed suit against the three largest pharmacy benefit managers in the country for anticompetitive business practices that artificially inflated the price of life-saving insulin drugs. The agency’s administrative complaint alleges CVS’ Caremark, Cigna’s Express Scripts and UnitedHealth’s Optum Rx steered patients toward higher priced insulin in order to bring in larger rebates from pharmaceutical manufacturers. As a result, patients who weren’t eligible for the lower discounted price faced higher costs, the FTC alleges. Caremark, Express Scripts and Optum Rx together control about 80% of U.S. prescriptions. <Read More> The Role of Clinical Pharmacists in Transforming Therapeutic Drug Monitoring – September 19, 2024 – Personalised medicine, the tailoring of medical treatment to each patient's individual characteristics, is revolutionising healthcare. At the heart of this transformation lies therapeutic drug monitoring (TDM), which measures drug concentrations in patients' blood to optimise therapy and minimise adverse effects. The clinical pharmacist or pharmacologist plays a pivotal role in the TDM laboratory, architecting personalised medication strategies. They are uniquely equipped for their role in the TDM laboratory due to their specialised training and expertise. Their in-depth knowledge of drug mechanisms, interactions, and metabolism allows them to interpret TDM data precisely and nuance. <Read More>

340B in the News

HRSA Issues Final Warning to J&J to Cease Implementation of its 340B Proposed Rebate Program – September 27, 2024 – The Health Resources and Services Administration Sept. 27 sent a final warning letter to Johnson & Johnson urging the company to inform the agency by Monday, Sept. 30 that it would halt its proposed 340B rebate model scheduled to go into effect next month. “As outlined in HRSA’s September 17, 2024, letter, if J&J proceeds with implementing its rebate proposal without Secretarial approval, it will violate section 340B(a)(1) of the Public Health Service Act,” HRSA wrote. “If J&J has not notified HRSA that it is ceasing implementation of its rebate proposal by September 30, 2024, HRSA will begin the process outlined in J&J’s Pharmaceutical Pricing Agreement related to terminating the agreement. In addition, if J&J moves forward with implementation of its rebate proposal, HRSA will initiate a referral to the HHS Office of Inspector General pursuant to 42 U.S.C. § 256b(d)(1)(B)(vi).” <Read More> Hopewell Health Centers Lays Off 35 Employees Because of Drug Manufacturers' Restrictions on a Little-Known Federal Program – September 24, 2024 – Being on Hopewell’s RN care management team was Erin Eddleblute’s dream job. “We were kind of — and this was how our boss referred to it and I loved it — the junk drawer of Hopewell,” Eddleblute said. She and the other RN care managers would work one-on-one with clients on all manner of issues...The team was small — just six people — but Eddleblute said their impact was large. Eddleblute estimates she saw around 250 people a year. And then, suddenly, it was all over…What Eddleblute didn’t understand was that the loss of her job was the direct result of a national sparring match between drug manufacturers and the beneficiaries of an obscure, but vital, initiative called the 340B Drug Pricing Program, which provides medication at a discount for vulnerable populations. The battle had played out far, far away from Eddleblute’s day-to-day life. Now, she was paying the cost. <Read More>

Will Sustained Pressure on the 340B Program Finally Lead to Much Needed Reform? – September 18, 2024 – As we enter into the final months of 2024, new developments in the administration of the 340B Drug Pricing Program signal that additional reform may be on the way. Although recent revisions to the 340B program’s administrative dispute resolution (ADR) process represented a positive development in program reform, many questions remain as to how the Health Resources and Services Administration (HRSA) along with Congress may resolve stakeholder concerns with the drug pricing program’s future. <Read More>

New Drug/Vaccine Approval

Lazcluze™ (lazertinib) Tablets – New Drug Approval – August 19, 2024 – The Food and Drug Administration approved lazertinib (Lazcluze™, Janssen Biotech, Inc.) in combination with amivantamab-vmjw (Rybrevant®, Janssen Biotech, Inc.) for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test. <Read More>

New Indication/Dosage/Formulation Approval

ACAM2000® (Smallpox and Mpox (Vaccinia) Vaccine, Live) – New Label Expansion – August 29, 2024 – Emergent BioSolutions Inc. (NYSE: EBS) announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for the expansion of the indication for ACAM2000®, (Smallpox and Mpox (Vaccinia) Vaccine, Live) to include prevention of mpox disease in individuals determined to be at high risk for mpox infection. The approval is based on previously available human safety data and data from a well-controlled animal study in which ACAM2000® vaccine was shown to be effective in protecting against mpox virus exposure. <Read More>  Spikevax® (Moderna COVID-19 Vaccine) (COVID-19 Vaccine, mRNA) Injection - New Label Expansion – August 22, 2024 – Moderna, Inc. (NASDAQ:MRNA) announced the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Spikevax® (2024-2025 formula) for individuals 12 years and above. Emergency Use Authorization (EUA) for the Moderna's COVID-19 Vaccine (2024-2025 formula) was also granted for individuals 6 months through 11 years of age. Moderna's updated COVID-19 vaccine targets the KP.2 variant of SARS-CoV-2 to help prevent COVID-19 in individuals 6 months of age and older. With the U.S. FDA's decision, Moderna's updated vaccine is expected to be available in the coming days. <Read More> Comirnaty® (COVID-19 Vaccine, mRNA) Injection – New Label Expansion – August 22, 2024 – Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) announced that the U.S. Food and Drug Administration (“FDA”) has approved the supplemental Biologics License Application for individuals 12 years of age and older (Comirnaty® (COVID-19 Vaccine, mRNA), and granted emergency use authorization for individuals 6 months through 11 years of age (Pfizer-BioNTech COVID-19 Vaccine) of the companies’ Omicron KP.2-adapted 2024-2025 Formula COVID-19 vaccine. <Read More> Imfinzi® (durvalumab) Injection – New Label Expansion – August 15, 2024 – The Food and Drug Administration approved durvalumab (Imfinzi®, AstraZeneca) with platinum-containing chemotherapy as neoadjuvant treatment, followed by single-agent durvalumab as adjuvant treatment after surgery for adults with resectable (tumors ≥ 4 cm and/or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. <Read More>

New Drug Shortage

August 28, 2024

• Clobetasol Propionate Spray (Discontinuation)

August 23, 2024

• Indocyanine Green Injection (Currently in Shortage)

August 21, 2024

• Hydrocortisone Probutate Cream (Discontinuation)

August 20, 2024 

• Cyclosporine Solution (Discontinuation)

August 14, 2024 

• Sildenafil Powder, for Suspension (Discontinuation)

Updated Drug Shortage

September 03, 2024

• Atropine Sulfate Injection (Currently in Shortage)

• Furosemide Injection (Currently in Shortage)

• Lisdexamfetamine Dimesylate Capsule (Currently in Shortage)

• Methylprednisolone Acetate Injection (Currently in Shortage)

• Midazolam Hydrochloride Injection (Currently in Shortage)

• Penicillin G Benzathine Injection (Currently in Shortage)

• Sodium Chloride 0.9% Injection (Currently in Shortage)

• Sterile Water Injection (Currently in Shortage)

August 30, 2024

• Remifentanil Hydrochloride Injection (Currently in Shortage)

August 29, 2024

• Oxybutynin Chloride Syrup (Resolved)

August 28, 2024

• Lidocaine Hydrochloride Injection (Currently in Shortage)

• Midazolam Hydrochloride Injection (Currently in Shortage)

• Promethazine Hydrochloride Injection (Currently in Shortage)

August 27, 2024

• Cyclopentolate Hydrochloride Ophthalmic Solution (Currently in Shortage)

New Drug Recall and Safety Alerts

No new update.

New Generic/Biosimilar Approval and Launch

No new update.

Clinical and Pharmacy News

It’s Not Just Big Pharma: Meet the Middlemen Blocking Access to Medication– August 31, 2024 – In 2012, Loretta Boesing received a mail-order shipment of her then-toddler aged son’s immunosuppressant medication, which he takes every 12 hours to prevent his body from rejecting his liver transplant. The medication, which arrived on a 102-degree day, had been shipped in a plastic envelope. Soon after taking the medicine, her son’s body began to reject his liver, leading to a terrifying two-week hospital stay. Boesing transferred his prescription to the hospital pharmacy to avoid similar issues in the future…Boesing discovered that a key player in the health care landscape was to blame for her forced switch to mail-order drugs: pharmacy benefit managers, or PBMs. PBMs operate as middlemen in the health care space, managing the pharmacy benefits that an insurer offers its patients. <Read More> IRA Biosimilar Measure Intended to Boost Uptake so far has 'Limited' Impact: Report – August 29, 2024 – It’s been two years since the Inflation Reduction Act (IRA) was passed, and, while the law's Medicare-negotiated price cuts haven’t yet gone into effect, a change surrounding biosimilar reimbursement rates was instated in 2022. The new provision was meant to dismantle financial disincentives to biosimilar adoption and save the U.S. healthcare system billions of dollars, but has the legislation worked to plan so far? Drug development consultancy Certara sought to find out. In its “Boost or Bust?” report, the company surveyed oncology account staff at 79 healthcare facilities—including a mix of hospitals and community infusion sites—on their use of 17 biosimilar products targeting five reference medicines… <Read More> Management of Pulmonary Arterial Hypertension – August 29, 2024 – Pulmonary arterial hypertension (PAH), a rare disease that falls under the larger umbrella of pulmonary hypertension (PH), is defined as increased pulmonary arterial pressure of at least 20 mm Hg at rest. The arteries in the lung become narrow or blocked, impeding blood flow. This, in turn, increases pulmonary vascular resistance, causing the right side of the heart to work harder to pump blood to the lungs. Over time, the heart muscle weakens, eventually leading to right ventricular failure. <Read More> Pharmacy Standing Order for Narcan Distribution Linked to Reduction in Overdose Deaths –August 29, 2024 – Expanding access to naloxone is a key component of the national strategy to end the opioid crisis in America, and community pharmacies play a central role in distributing this overdose-reversing medication. Prior to naloxone receiving federal approval for over-the-counter availability as Narcan nasal spray in 2023, almost all US states allowed individuals to obtain the life-saving drug at community pharmacies without a prescription through a state authorization known as a standing order. But there remains a limited understanding on whether pharmacy naloxone distribution had any effect on reducing opioid overdose deaths in communities. <Read More> FDA Approves/Authorizes Updated COVID-19 Vaccines; Target KP.2 Omicron Variant of SARS-CoV-2 – August 23, 2024 – The FDA approved and granted emergency use authorization (EUA) for updated mRNA COVID-19 vaccines (2024-2025 formula), which include a monovalent component that corresponds to the omicron variant KP.2 strain of SARS-CoV-2. The mRNA COVID-19 vaccines by Moderna and Pfizer-BioNTech have updated the formula to more closely target circulating variants and to provide better protection against serious consequences of COVID-19, including hospitalization and death, the FDA said in a statement. <Read More>

340B in the News

The Future of the 340B Drug Pricing Program in Modern Health Care– August 30, 2024 – An examination of the 340B Drug Pricing Program's original intent, current challenges, and potential resolutions in today's complex health care landscape. The 340B Drug Pricing Program, established by Congress in 1992, has become a critical component of the US health care system. This federal program requires pharmaceutical manufacturers to provide outpatient drugs at significantly discounted prices to eligible health care organizations, known as covered entities.² As the program enters its fourth decade, it faces numerous challenges that threaten its original mission and impact pharmacy practice. <Read More> HRSA Tells Johnson & Johnson to Nix its Plan for 340B Drug Rebates – August 23, 2024 – The Health Resources & Services Administration has told Johnson & Johnson it cannot use a rebate model to replace upfront discounts in its 340B drug pricing program, according to the American Hospital Association. On Aug. 23, Johnson & Johnson announced that it will change the way it makes 340B pricing available for two of its most popular products, Stelara® and Xarelto®. Starting Oct. 15, J&J said it will require all disproportionate share hospitals participating in the 340B Drug Pricing Program to purchase these drugs at full price and submit data to J&J. Upon verification of the drug's 340B status, the DSH hospitals will receive a rebate for the discounted 340B price. <Read More>

New Drug/Vaccine Approval

Niktimvo™ (axatilimab-csfr) Injection – New Drug Approval – August 14, 2024 – The Food and Drug Administration approved axatilimab-csfr (Niktimvo™, Incyte Corporation), a colony stimulating factor-1 receptor-blocking antibody, for the treatment of chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg. <Read More> Livdelzi® (seladelpar) Capsules – New Drug Approval – August 14, 2024 – Gilead Sciences, Inc. (Nasdaq: GILD) announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Livdelzi® (seladelpar) for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. The use of Livdelzi® is not recommended for people who have or develop decompensated cirrhosis. <Read More> Nemluvio® (nemolizumab) for Injection – New Drug Approval – August 12, 2024 – Galderma announced that the U.S. Food and Drug Administration (FDA) has approved Nemluvio® (nemolizumab) as a pre-filled pen for subcutaneous injection for the treatment of adults with prurigo nodularis. Nemluvio® was granted Breakthrough Therapy Designation in December 2019 and Priority Review in February 2024 by the U.S. FDA – a status reserved for medicines with the potential to significantly improve the treatment of serious conditions. <Read More> neffy® (epinephrine) Nasal Spray – New Drug Approval – August 9, 2024 – The U.S. Food and Drug Administration approved neffy® (epinephrine nasal spray) for the emergency treatment of allergic reactions (Type I), including those that are life-threatening (anaphylaxis), in adult and pediatric patients who weigh at least 30 kilograms (about 66 pounds). <Read More> Yorvipath® (palopegteriparatide) Injection – New Orphan Drug Approval – August 9, 2024 – Ascendis Pharma A/S (Nasdaq: ASND) announced that the U.S. Food & Drug Administration (FDA) has approved Yorvipath® (palopegteriparatide; developed as TransCon PTH) for the treatment of hypoparathyroidism in adults. Yorvipath® is a prodrug of parathyroid hormone (PTH[1-34]), administered once daily, designed to provide continuous exposure to released PTH over the 24-hour dosing period. Hypoparathyroidism is a rare endocrine disease caused by insufficient levels of parathyroid hormone that impact multiple organs and affects an estimated 70,000 to 90,000 people in the United States. <Read More> Zurnai™ (nalmefene hydrochloride) Injection – New Drug Approval – August 7, 2024 – the U.S. Food and Drug Administration approved Zurnai™, the first nalmefene hydrochloride auto-injector for the emergency treatment of known or suspected opioid overdose in adults and pediatric patients 12 years of age and older. The agency approved the first nasal spray formulation of nalmefene in May 2023. <Read More> Lymphir™ (denileukin diftitox-cxdl) for Injection – New Orphan Drug Approval – August 7, 2024 – Citius Pharmaceuticals, Inc. (NASDAQ: CTXR) ("Citius", "Citius Pharma"), announced that the U.S. Food and Drug Administration (FDA) has approved Lymphir™ (denileukin diftitox-cxdl), a novel immunotherapy for the treatment of r/r cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy. Lymphir™ is the only CTCL therapy that targets the interleukin-2 (IL-2) receptor found on malignant T-cells and Tregs. This is the first indication for Lymphir™ and the first FDA-approved product for Citius Pharma. <Read More> Crexont® (carbidopa and levodopa) Extended-Release Capsules – New Drug Approval – August 7, 2024 – Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) announced that the U.S. Food and Drug Administration (FDA) has approved Crexont® (carbidopa and levodopa) extended-release capsules for the treatment of Parkinson’s disease (PD). Crexont® is a novel, oral formulation of carbidopa/levodopa (CD/LD) that combines both immediate-release (IR) granules and extended-release (ER) pellets. <Read More> Voranigo® (vorasidenib) Tablets – New Orphan Drug Approval – August 6, 2024 – The Food and Drug Administration approved vorasidenib (Voranigo®, Servier Pharmaceuticals LLC), an isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitor, for adult and pediatric patients 12 years and older with Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation, following surgery including biopsy, sub-total resection, or gross total resection. <Read More>

New Indication/Dosage/Formulation Approval

Furoscix® (furosemide) Injection – New Label Expansion – August 9, 2024 – scPharmaceuticals Inc. (Nasdaq: SCPH) (the “Company”), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs, announced that the Food and Drug Administration (FDA) has approved its Supplemental New Drug Application (sNDA) seeking to expand the Furoscix® indication for heart failure patients. At approval, Furoscix® was only indicated for the treatment of congestion due to fluid overload in adult patients with New York Heart Association (NYHA) Class II and Class III chronic heart failure. The new indication now includes patients with NYHA Class IV chronic heart failure who represent the most symptomatic patients and those with the greatest limitation on physical activity, comprising approximately 10% of all heart failure patients nationally. <Read More> Fabhalta® (iptacopan) Capsules – New Label Expansion – August 7, 2024 – Novartis announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Fabhalta® (iptacopan), a first-in-class complement inhibitor for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression. This is generally defined as a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/g1. Fabhalta® specifically targets the alternative complement pathway of the immune system. When overly activated in the kidneys, the complement system is thought to contribute to the pathogenesis of IgAN. <Read More> Imfinzi® (durvalumab) Injection – New Label Expansion – August 15, 2024 – AstraZeneca’s Imfinzi® (durvalumab) in combination with chemotherapy has been approved in the US for the treatment of adult patients with resectable early-stage (IIA-IIIB) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. In this regimen, patients are treated with Imfinzi in combination with neoadjuvant chemotherapy before surgery and as adjuvant monotherapy after surgery. <Read More> NexoBrid® (anacaulase-bcdb) Lyophilized Powder for Topical Gel – New Label Expansion – August 15, 2024 – Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, announced that the U.S. Food and Drug Administration (FDA) has approved a pediatric indication for NexoBrid® (anacaulase-bcdb) for eschar removal in pediatric patients with deep partial-thickness and/or full-thickness thermal burns. <Read More>

New Drug Shortage

August 08, 2024

• Bromocriptine Mesylate Tablet (Discontinuation)

August 07, 2024

• Memantine Hydrochloride Capsule, Extended Release (Discontinuation)

Updated Drug Shortage

August 06, 2024

• Carboplatin Injection (Currently in Shortage)

• Semaglutide Injection (Currently in Shortage)

August 05, 2024

• Bupivacaine Hydrochloride Injection (Currently in Shortage)

• Dexamethasone Sodium Phosphate Injection (Currently in Shortage)

• Lidocaine Hydrochloride Injection (Currently in Shortage)

• Methylprednisolone Acetate Injection (Currently in Shortage)

• Rocuronium Bromide Injection (Currently in Shortage)

• Ropivacaine Hydrochloride Injection (Currently in Shortage)

New Drug Recall and Safety Alerts

0.9% Sodium Chloride for Injection USP 1000 mL in E3 Containers – New Voluntary Recall – August 8, 2024 – B. Braun Medical Inc. (B. Braun), is voluntarily recalling two (2) lots of 0.9% Sodium Chloride for Injection USP 1000 mL in E3 containers within the United States to the consumer level. The voluntary recall has been initiated due to the potential for particulate matter and fluid leakage of the respective containers. <Read More>

Heparin Sodium 0.9% Sodium Chloride Injection by Baxter – New Voluntary Recall – August 6, 2024 – Baxter International Inc. (NYSE:BAX) is voluntarily recalling one lot of Heparin Sodium in 0.9% Sodium Chloride Injection to the consumer level due to the potential for elevated endotoxin levels based on issues related to the bacterial endotoxin test specific to lot number N008235. <Read More>

New Generic/Biosimilar Approval and Launch

Enzeevu™ (aflibercept-abzv) Injection – New Biosimilar Approval – August 9, 2024 – Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in generic and biosimilar medicines, announced that the US Food and Drug Administration (FDA) has approved Enzeevu™ (aflibercept-abzv) 2 mg vial kit and pre-filled syringe for intravitreal injection. Enzeevu™ is indicated to improve and maintain visual acuity in patients with neovascular age-related macular degeneration (nAMD). In addition, the FDA provisionally determined Enzeevu™ would be interchangeable with the reference medicine as it is currently subject to an unexpired exclusivity for the first interchangeable biosimilar products. <Read More>

Clinical and Pharmacy News

Why America’s Healthcare System Needs More Pharmacies – August 19, 2024 – Our most frequent interactions with America’s healthcare system aren’t typically at a doctor’s office, hospital, or urgent care center. Rather, we find ourselves—once a month or more—at a counter tucked inside our local pharmacy. These frontline pharmacists and pharmacy techs don’t just fill our prescriptions. They recommend over-the-counter treatments, give us our annual vaccines, talk to us about drug interactions, and much more. Most importantly, they’re always there—available to chat often late into the night without a pre-scheduled appointment or hours-long wait. Sadly, the business of pharmacy is tough and just getting tougher. <Read More> Better Utilization Management Needed For GLP-1 Agonists – August 16, 2024 – Glucagon-like peptide-1 (GLP-1) agonists have garnered significant public interest over the past year, partly due to celebrities using them and posting on social media. However, many patients fare equally well losing weight through lifestyle modifications and less expensive medications such as phentermine, experts from Kaiser Permanente said at AMCP 2024, in New Orleans. They discussed assorted utilization management techniques to ensure GLP-1 agonists are deployed appropriately. <Read More> New International Guidelines Could Boost Accuracy for Cancer Genetic Testing –August 15, 2024 – New international guidelines developed by QIMR Berghofer researchers are expected to improve the accuracy of genetic tests that determine a person's cancer risk. As genetic testing becomes more prevalent, many people want to understand their likelihood of developing cancer. These new guidelines are expected to reduce the number of uncertain test results by up to 85%, helping to avoid unnecessary medical treatment and anxiety. The guidelines apply to testing for BRCA1 and BRCA2 gene variants, which play a crucial role in determining a person's risk of hereditary breast and ovarian cancer and other related cancers. <Read More> Acute Bacterial Arthritis in Children: New Guidelines – August 15, 2024 – A session at the 2024 Pediatric Academic Societies annual meeting reviewed the latest clinical practice guideline for acute bacterial arthritis (ABA) in children, developed by a multidisciplinary panel representing the Pediatric Infectious Diseases Society and the Infectious Diseases Society of America. These guidelines apply to children aged 1 month to 17 years, and the definition of ABA used throughout the guidelines is bacterial infection of joint fluid along with signs of infection. <Read More> How Digital Delivery Can Empower Staff and Shape the Future of Pharmacy –August 13, 2024 – If we can shift the way we deliver information, we can change the entire culture of pharmacy in a way that relieves some of the burden on the pharmacists and improves patient outcomes at the same time. When patients pick up a prescription medication (or have one delivered), two things typically happen. First, the individual is asked if they want counseling from, or have any questions for, the pharmacist. Second, a sheaf of papers is stapled to the bag the medication is placed in. The papers feature information about the type of medication that has been prescribed, what it is for, and side effects to look out for. Isn’t this happening in the wrong order? <Read More>

340B in the News

340B Participation May Hamper Biosimilars Uptake – August 14, 2024 – Are hospitals participating in the federal 340B Drug Pricing Program less motivated to prescribe biosimilars over their higher priced originator products? That’s the conclusion of a recent study published in Health Affairs (2023;42[5]:632-641) that suggests reforms to the drug discount program are needed to nudge hospitals and providers toward using biosimilars. The research, from a trio of health economists, found that in hospital outpatient settings, participating in the 340B program was associated with more hospital-based administrations of biologic medications and less usage of biosimilars. The more frequent use of biologics also yielded increased revenue for 340B program participants. <Read More>