New Drug/Vaccine Approval

Wainua™ (eplontersen) Injection – New Orphan Drug Approval – December 21, 2023 – Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced that the U.S. Food and Drug Administration (FDA) has approved Ionis and AstraZeneca's Wainua™ (eplontersen) for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults, commonly referred to as hATTR-PN or ATTRv-PN. Wainua™ is the only approved medicine for the treatment of ATTRv-PN that can be self-administered via an auto-injector. <Read More> Filsuvez® (birch triterpenes) Topical Gel - formerly Oleogel-S10 – New Drug Approval – December 19, 2023 - Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people affected by rare diseases, announced that the U.S. Food and Drug Administration (FDA) approved Filsuvez® (birch triterpenes) topical gel for the treatment of partial thickness wounds in patients 6 months and older with Junctional Epidermolysis Bullosa (JEB) and Dystrophic Epidermolysis Bullosa (DEB). Filsuvez® is the first approved treatment for wounds associated with JEB, a rare, moderate-to-severe form of EB with blisters beginning in infancy. Filsuvez® joined the Chiesi portfolio as part of the agreement reached during the acquisition of Amryt Pharma in January of this year. <Read More> Alyglo™ (Immune Globulin Intravenous, Human-stwk) 10% Liquid – New Drug Approval – December 17, 2023 – GC Biopharma USA, Inc. announced that the US Food and Drug Administration (FDA) has approved Alyglo™ (immune globulin intravenous, human-stwk) 10% Liquid, formerly referred to as “G5107B,” for the treatment of adult patients aged 17 years and older with primary humoral immunodeficiency (PI). The Alyglo™ pivotal phase 3 clinical study followed FDA guidance for the treatment of patients with PI. <Read More>

New Indication/Dosage/Formulation Approval

Tarpeyo® (budesonide) – New Label Expansion – December 20, 2023 - Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”), announced that the U.S. Food and Drug Administration (FDA) has approved Tarpeyo® (budesonide) delayed release capsules to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression. Tarpeyo® was first approved in December 2021 under accelerated approval, based on the surrogate marker of proteinuria. Marking a significant milestone, Tarpeyo® is now the first fully FDA-approved treatment for IgAN based on a measure of kidney function. <Read More> Padcev® (enfortumab vedotin-ejfv) and Keytruda® (pembrolizumab) – New Label Expansion – December 15, 2023 – Astellas Pharma Inc. (TSE:4503) and Pfizer Inc. (NYSE: PFE) announced that on December 15, 2023 the U.S. Food and Drug Administration (FDA) has approved Padcev® (enfortumab vedotin-ejfv, an antibody-drug conjugate [ADC]) with Keytruda® (pembrolizumab, a PD-1 inhibitor) for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC). This combination is the first approved to offer an alternative to platinum-containing chemotherapy, the current standard of care in first-line la/mUC. <Read More> Adbry® (tralokinumab-ldrm) Injection – New Label Expansion – December 14, 2023 – LEO Pharma Inc. announced that the U.S. Food and Drug Administration (FDA) has expanded the approval of Adbry® (tralokinumab-ldrm) to include pediatric patients aged 12-17 years with moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Adbry® is the first and only FDA-approved biologic that specifically binds to and inhibits the interleukin (IL)-13 cytokine, one of the key drivers of AD signs and symptoms. <Read More> Nexletol® (bempedoic acid) and Nexlizet® (bempedoic acid and ezetimibe) Tablets – New Label Expansion – December 13, 2023 – Esperion (NASDAQ: ESPR) announced that the U.S. Food and Drug Administration (FDA) has approved an updated LDL-cholesterol lowering indication for Nexletol® and Nexlizet® to include the treatment of primary hyperlipidemia as a qualifier for existing approved populations. Additionally, the maximally tolerated qualifier for statin use has been removed, and the prior limitation of use stating “the effect of Nexlizet® or Nexletol® on cardiovascular morbidity and mortality has not been determined” has also been removed. <Read More>  Trogarzo® (ibalizumab-uiyk) Injection – New Label Expansion – December 12, 2023 – Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, announced that the United States Food and Drug Administration (FDA) has approved the company’s Labelling Prior Approval Supplement to include a 2000-mg intravenous (IV) push loading dose for Trogarzo® (ibalizumab-uiyk). IV push is a method by which the undiluted medication is “pushed” by syringe for faster administration into the body’s circulation and is designed to make Trogarzo® administration easier and more convenient for people with HIV and their health care providers. As a result, more clinics will be able to initiate new patients and provide ongoing treatment. <Read More>

New Drug Shortage

December 28, 2023

• Bupropion Hydrochloride Tablet, Extended Release (Discontinuation)

December 27, 2023

• NIFEDIPINE CAPSULE (Discontinuation)

• Technetium TC-99M Pyrophosphate Kit Injection (Currently in Shortage)

December 21, 2023

• Sodium Acetate Injection (Currently in Shortage)

December 20, 2023

• Methotrexate Sodium Injection (Currently in Shortage)

December 19, 2023

• Somatropin Injection (Currently in Shortage)

Updated Drug Shortage

January 02, 2024

• Cisplatin Injection (Currently in Shortage)

• Lisdexamfetamine Dimesylate Capsule (Currently in Shortage)

December 28, 2023

• Azacitidine Injection (Currently in Shortage)

• Carboplatin Injection (Currently in Shortage)

• Cefixime Capsule (Currently in Shortage)

• Cisplatin Injection (Currently in Shortage)

• Clonazepam Tablet (Currently in Shortage)

• Conivaptan Hydrochloride Injection (Currently in Shortage)

• Dexmedetomidine Hydrochloride Injection (Currently in Shortage)

• Disopyramide Phosphate Capsule (Currently in Shortage)

• Fluconazole Injection (Currently in Shortage)

• Methyldopa Tablet, Film Coated (Currently in Shortage)

• Metronidazole Injection (Currently in Shortage)

• Quinapril/Hydrochlorothiazide Tablet (Currently in Shortage)

• Sulfasalazine Tablet (Currently in Shortage)

• Trimethobenzamide Hydrochloride Capsule (Currently in Shortage)

• Trimethobenzamide Hydrochloride Capsule (Discontinuation)

• Valproate Sodium Injection (Currently in Shortage)

December 27, 2023

• Fentanyl Citrate Injection (Currently in Shortage)

• Heparin Sodium Injection (Currently in Shortage)

• Hydromorphone Hydrochloride Injection (Currently in Shortage)

• Morphine Sulfate Injection (Currently in Shortage)

• Sodium Bicarbonate Injection (Currently in Shortage)

• Somatropin Injection (Currently in Shortage)

• Sufentanil Citrate Injection (Currently in Shortage)

December 22, 2023

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

• Carboplatin Injection (Currently in Shortage)

• Midazolam Hydrochloride Injection (Currently in Shortage)

• Morphine Sulfate Injection (Currently in Shortage)

• Semaglutide Injection (Currently in Shortage)

• Sodium Acetate Injection (Currently in Shortage)

• Sodium Bicarbonate Injection (Currently in Shortage)

December 21, 2023

• Gentamicin Sulfate Injection (Currently in Shortage)

• Nitroglycerin Injection (Currently in Shortage)

• Parathyroid Hormone Injection (Currently in Shortage)

• Sodium Acetate Injection (Currently in Shortage)

• Sucralfate Tablet (Currently in Shortage)

New Drug Recall and Safety Alerts

4.2% Sodium Bicarbonate Injection, 8.4% Sodium Bicarbonate Injection, and Atropine Sulfate Injection by Hospira, Inc. – New Voluntary Recall – December 26, 2023 – Hospira, Inc., a Pfizer company, is voluntarily recalling the lots listed in the table below of 4.2% Sodium Bicarbonate Injection, USP Abboject® Glass Syringe, 5 mEq/10 mL; 8.4% Sodium Bicarbonate Injection, USP Lifeshield® Abboject® Glass Syringe, 50 mEq/50 mL; and Atropine Sulfate Injection, USP Lifeshield® Abboject® Glass Syringe, 1 mg/10 mL to the user level. The recall was initiated due to the potential for presence of glass particulate matter, identified during product inspection. <Read More> Americaine® 20% Benzocaine Topical Anesthetic Spray by Insight Pharmaceuticals – New Voluntary Recall – December 22, 2023 – Insight Pharmaceuticals, a Prestige Consumer Healthcare Inc. company (“Insight”), is voluntarily recalling one lot of Americaine® 20% Benzocaine Topical Anesthetic Spray to the consumer level. While benzene is not an ingredient in any Americaine® 20% Benzocaine Topical Anesthetic Spray products, a recent review by our manufacturer and their third-party lab found that a sample from one lot of the product showed a low level of benzene came from the propellant that sprays the product out of the can. <Read More> Bleomycin for Injection, USP 15 Units Single Dose Onco-Tain™ Glass Fliptop Vial by Hospira, Inc. – New Voluntary Recall – December 22, 2023 - Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of Bleomycin for Injection, USP 15 units Single Dose Onco-Tain™ Glass Fliptop Vial, lot BL12206A, to the user level. The recall was initiated due to a confirmed customer report for the presence of glass particulate within a single vial. <Read More>

New Generic/Biosimilar Approval and Launch

Condylox Gel 0.5%® - New Generic Approval – December 4, 2023 – Hyloris Pharmaceuticals SA (Euronext Brussels: HYL), a specialty biopharma company committed to addressing unmet medical needs through reinventing existing medications, announced that its partner Padagis US LLC has received final approval from the United States Food & Drug Administration (FDA) on its abbreviated New Drug Application (ANDA) for Podofilox Gel, the first drug product generic to Condylox Gel 0.5%® in the U.S. Podofilox Gel is an antimycotic drug for the topical treatment of external genital and perianal warts. <Read More>

Clinical and Pharmacy News

A Popular Asthma Inhaler is Leaving Pharmacy Shelves. Here's What You Need to Know – December 30, 2023 – Some asthma patients may start out the new year scrambling for their go-to inhaler – at least that's the concern as Flovent, a popular drug, leaves store shelves starting in January. Earlier this year, drugmaker GSK announced it's discontinuing Flovent in 2024. There is a generic version to take its place, but some doctors worry patients could be left in the lurch as they sort out how to get the new medication covered by insurance. <Read More> Controlled Substance Transfers: Ensuring Internal Management From Site to Site – December 22, 2023 – Controlled substance transfers are occurring at a higher rate as health systems create their own ecosystems to combat medication shortages. Whenever medications are purchased from any entity, a process must be followed that allows for tracing the medications with ease. When it comes to controlled substances, every individual vial, syringe, or bag must be easily tracked. When pharmacies order medication from traditional distributors, the process is rather automated and straight forward. However, when alternative or home-grown methods of acquiring controlled substances are utilized, additional review of the ordering process, completion of forms, transportation, and receipt of the medication must be put under the microscope to ensure the Code of Federal Regulations (CFR) Title 21 and state regulations are followed. <Read More> Senate Inquiry Reveals Widespread Flaws in Maintaining Pharmacy Customer Data Privacy – December 22, 2023 – Results of a new inquiry conducted by the Senate Finance Committee revealed major flaws regarding how pharmacy chains protect, or fail to protect, customer data. The inquiry, helmed by Senate Finance Committee Chair Ron Wyden (D, Oregon), Representative Pramila Jayapal (D, Washington), and Representative Sara Jacobs (D, California), found that unless a state law is established that requires it, major pharmacy chains do not need a warrant to share prescription data and other health records with law enforcement agencies. The pharmacies to which these findings apply include household names such as CVS Health, Walgreens Boots Alliance, Cigna, Optum Rx, Walmart Stores, the Kroger Company, Rite Aid Corporation, and Amazon Pharmacy. <Read More> FDA Warns Consumers Not to use Counterfeit Ozempic® (semaglutide) Found in U.S. Drug Supply Chain – December 21, 2023 - FDA continues to investigate counterfeit Ozempic® (semaglutide) injection 1 milligram (mg) in the legitimate U.S. drug supply chain and has seized thousands of units of the product. The agency advises wholesalers, retail pharmacies, health care practitioners and patients to check the product they have received and not distribute, use, or sell products labeled with lot number NAR0074 and serial number 430834149057 as pictured below. Some counterfeit products may still be available for purchase. <Read More> The Role of Pharmacists in HIV Care Continues to Expand – December 21, 2023 – HIV affects 1.2 million people in the United States. Despite the development of effective agents for treatment and prevention of HIV, current rates of viral suppression, pre-exposure prophylaxis and linkage to care fall short of the goals set by the CDC for ending the HIV epidemic. Additionally, the presence of pharmacists in specialty settings, including HIV, has expanded in recent years. Clinical pharmacists are essential components of the interdisciplinary team by providing comprehensive medication management to this complex patient population. <Read More>

340B in the News

AHA Files Friend-of-the-Court Brief Defending Louisiana 340B Contract Pharmacy Law – December 27, 2023 – AHA filed a friend-of-the-court brief in support of a Louisiana law that prohibits drug companies from denying Louisiana hospitals the same 340B discounts for drugs dispensed at community pharmacies that would be provided via in-house pharmacies. PhRMA and AstraZeneca challenged the state law as preempted by the federal law that created the 340B program, and AHA asserts that their challenge should be rejected. “PhRMA and AstraZeneca cannot demonstrate that Congress intended to create or occupy any field through its 340B legislation,” the brief states. <Read More>

New HRSA 340B Program Resource Asserts Agency’s Position on “Patient” Definition – December 21, 2023 – On December 14, 2023, Health Resources & Services Administration (HRSA) announced a new resource on the 340B Program website compiling resources associated with the 340B Program definition of “patient.” The website is available here. While the HRSA website compiling patient definition resources is new, none of the content is new. The website only provides links to existing HRSA and Apexus materials. The website makes clear that HRSA’s position is that it continues to rely on its 1996 guidance in interpreting the 340B Statute’s use of the term “patient.” The timing of this new resource page in connection with last month’s decision in the Genesis case is likely not coincidental, as many 340B covered entities and other 340B Program stakeholders have been closely evaluating the 340B Program definition of “patient” following that decision. <Read More>

New Drug/Vaccine Approval

Zelsuvmi™ (berdazimer sodium) Topical Gel – New Drug Approval – January 5, 2024 - Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announced that the U.S. Food and Drug Administration (FDA) has approved Zelsuvmi™ (berdazimer topical gel, 10.3%) for the treatment of molluscum contagiosum (molluscum) in adults and pediatric patients one year of age and older. The FDA approved Zelsuvmi™ as the first novel drug for the treatment of molluscum infections. Zelsuvmi™ is the first and only topical prescription medication that can be applied by patients, parents, or caregivers at home, outside of a physician's office, or other medical setting to treat this highly contagious viral skin infection. <Read More>

New Indication/Dosage/Formulation Approval

Zoryve® (roflumilast) Cream and Foam – New Label Expansion – January 15, 2024 – Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage company focused on developing meaningful innovations in immuno-dermatology, announced the U.S. Food and Drug Administration (FDA) has approved the new drug application (NDA) for Zoryve® (roflumilast) topical foam, 0.3% for the treatment of seborrheic dermatitis in individuals 9 years of age and older. <Read More> Yescarta® (axicabtagene ciloleucel) Suspension for Intravenous Infusion – New Label Expansion – December 21, 2023 – Kite, a Gilead Company (Nasdaq: GILD), announced that the U.S. Food and Drug Administration (FDA) has approved a label update for Yescarta® (axicabtagene ciloleucel) to include the overall survival (OS) primary analysis from the landmark Phase 3 ZUMA-7 study showing a statistically significant improvement for Yescarta® in OS versus standard of care (SOC) as second-line treatment with curative intent for patients with relapsed or refractory large B-cell lymphoma (R/R LBCL) within 12 months of completion of first-line therapy. <Read More> Brukinsa® (zanubrutinib) Capsules – New Label Expansion – December 21, 2023 – BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, announced the U.S. Food and Drug Administration (FDA) has approved a label update for Brukinsa® (zanubrutinib) to include superior progression-free survival (PFS) results from the Phase 3 ALPINE trial comparing Brukinsa® against Imbruvica® (ibrutinib) in previously treated patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL). <Read More>

New Drug Shortage

January 8, 2024

• Carboplatin Injection (Currently in Shortage)

Updated Drug Shortage

January 09, 2024

• Triamcinolone Acetonide Injection (Currently in Shortage)

• Valproate Sodium Injection (Discontinuation)

January 08, 2024

• Liraglutide Injection (Currently in Shortage)

January 05, 2024

• Cisplatin Injection (Currently in Shortage)

January 02, 2024

• Dextrose Monohydrate, Lidocaine Hydrochloride Anhydrous Injection (Currently in Shortage)

• I.V. Fat Emulsion (Currently in Shortage)

• Lisdexamfetamine Dimesylate Capsule (Currently in Shortage)

• Mannitol Injection (Currently in Shortage)

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

New Drug Recall and Safety Alerts

Vancomycin IV Bags, Phenylephrine IV Bags, and Fentanyl IV Bags by Leiters Health - New Voluntary Recall – January 8, 2024 – Leiters Health is voluntarily recalling 33 lots of products listed below to the user level. The recalled batches of vancomycin IV bags, phenylephrine IV bags, and fentanyl IV bags are being recalled due to the potential for superpotency because they may contain twice the labeled amount of drug. <Read More>

New Generic/Biosimilar Approval and Launch

Udenyca® Onbody™ (pegfilgrastim-cbqv) Injection Kit – New Biosimilar Approval for Neulasta® Onpro® (pegfilgrastim) – December 26, 2023 – Coherus BioSciences, Inc. (Coherus, Nasdaq: CHRS), a commercial-stage biopharmaceutical company focused on the research, development and commercialization of innovative immunotherapies to treat cancer, announced that the U.S. Food and Drug Administration (FDA) approved Udenyca® Onbody™, the company's on-body injector (OBI) presentation of Udenyca® (pegfilgrastim-cbqv), a pegfilgrastim biosimilar administered the day after chemotherapy to decrease the incidence of infection as manifested by febrile neutropenia. <Read More>

Clinical and Pharmacy News

How Pharmacists Can Successfully Navigate the FDA’s New DSCSA Stabilization Policy – January 9, 2024 – In August, the FDA issued a 1-year stabilization policy on the final enhanced drug distribution security requirements under the DSCSA. What exactly does that mean for pharmacists? The Drug Supply Chain Security Act (DSCSA) was set into motion nearly 10 years ago, becoming law on November 27, 2013. The law aims to help the FDA protect consumers from exposure to drugs that may be harmful by improving the detection of potentially dangerous drugs in the US supply chain. The DSCSA outlines steps that manufacturers, wholesalers, and dispensers need to follow to achieve electronic tracing of products at the package level as they are distributed. <Read More> Adapting to the FDA's Phenylephrine Status Change in OTC Cold and Congestion Medications – January 8, 2024 – The realm of OTC medications, often considered a quick and accessible remedy for common ailments, is currently undergoing a transformative phase. The catalyst for this change is the revised status of phenylephrine, a key ingredient in numerous OTC cold and congestion medications, as mandated by the FDA. Phenylephrine, a nasal decongestant, has long been used to alleviate nasal congestion in various OTC formulations. Its mechanism involves narrowing blood vessels in the nasal passages, effectively reducing swelling and facilitating easier breathing. Widely used and believed to be safe and effective, phenylephrine has been a staple ingredient in many cold and congestion medications available without a prescription. However, only 38% of the phenylephrine dose is bioavailable after ingestion, resulting in insufficient concentration to reach systemic circulation, and hence ineffective when taken orally. <Read More> Three Methods for Effectively Training the Next Generation of Pharmacy Leaders – January 8, 2024 – To develop the next generation of pharmacy leaders, pharmacists should receive effective training from the beginning of their careers. Training the next generation of health care leaders is crucial for the future of pharmacy, which is an ever-changing and ever-expanding field. Pharmacists are an important facet of health care leadership and, to develop the next generation of pharmacy leaders, these professionals require training from the beginning of their careers. To support this need, there are a few methods of training available. <Read More> Colorado System Turns to Apprenticeships to Ease Tech Shortage – January 3, 2024 – Children's Hospital Colorado did not have the resources to pay pharmacy techs more or create a training program, so it established apprenticeships to solve the workforce shortage. Hospitals have dealt with a pharmacy tech shortage for at least a decade. In 2021, the turnover rate was 20%, and 1 in 10 pharmacy directors said they had lost 40% or more of their pharmacy technicians, according to a Jan. 2 post from the American Society of Health-System Pharmacists. In the post-pandemic landscape, occupational burnout and costs of living have risen while pharmacy tech pay has stagnated. Jennifer Hamner, PharmD, director of pharmacy professional development at the health system, said a pharmacy technician who was leaving Children's Hospital told her he made more money working for Uber. <Read More>

340B in the News

Increasing Transparency in the 340B and Medicaid Drug Rebate Programs – January 9, 2024 – Recent court rulings have thrust the 340B Drug Pricing Program back in the headlines, and it is worth examining some of the lesser-known aspects of how this program interacts with state and federal Medicaid dollars, specifically through the Medicaid Drug Rebate Program (MDRP). While well-intentioned and created with bipartisan support, both initiatives have now morphed, decades later, into an opaque tapestry—and as such, are facing increasing scrutiny from lawmakers and the public. Here, we make a case that the MDRP can be used as one avenue for reforming 340B by increasing transparency to ensure it continues to meet the intent of the original legislation. <Read More> FDA Authorizes Florida's Drug Importation Program – January 5, 2024 – The FDA authorized the Florida Agency for Health Care Administration’s drug importation program to enable Florida to import bulk quantities of certain prescription drugs from Canada, which the state claims will lower drug costs. The ASHP, however, opposes state importation of drugs from Canada because it could disrupt the pharmacist-patient relationship, particularly for patients with complex medication regimens, and because it is not a meaningful response to drug pricing, the association said. “This drug importation proposal is not a real solution. The Canadian market cannot supply anywhere close to the amount of medication needed to bring down U.S. drug prices. Patients also need to know that this approach undermines the protections that pharmacists and physicians rely on to keep our drug supply safe,” said Tom Kraus, ASHP vice president of government relations. <Read More> AHA Comments on Proposed Medicare Advantage Policies for 2025 – January 5, 2024 – AHA Jan. 5 voiced strong support for Centers for Medicare & Medicaid Services proposals to increase oversight and enhance consumer protections in the Medicare Advantage program for contract year 2025, which would strengthen data collection and reporting, MA appeals rights and processes, and network adequacy for behavioral health services. AHA also urged CMS to ensure that MA plans accurately report appeals measures data used to calculate star ratings and plan utilization management committees conduct an annual health equity analysis. In addition, AHA pressed CMS to make hospitals whole for past MA underpayments to 340B hospitals and establish guardrails on the use of AI tools that may facilitate automatic claim denials. <Read More> Once Again, Gilead Attacks the Healthcare Safety Net – January 4, 2024 - Gilead Sciences furthers its assault on safety-net healthcare providers by expanding its 340B contract pharmacy restrictions to include clinics that serve the poor with in-house pharmacies.  AIDS Healthcare Foundation condemns the maneuver driven entirely by Gilead’s greed.  The drug maker will increase profits by limiting access to branded hepatitis C medications available at legally mandated 340B prices.  Wrapping itself in the flag of transparency, Gilead aims to reduce the number of prescriptions it must sell at the 340B discount price to access the lucrative, taxpayer-subsidized Medicaid prescription drug market. <Read More>

New Drug/Vaccine Approval

Balversa® (erdafitinib) Tablets – New Label Expansion – January 19, 2024 – The Food and Drug Administration approved erdafitinib (Balversa®, Janssen Biotech) for adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations, as determined by an FDA-approved companion diagnostic test, whose disease has progressed on or after at least one line of prior systemic therapy. Erdafitinib is not recommended for the treatment of patients who are eligible for and have not received prior PD-1 or PD-L1 inhibitor therapy. This approval amends the indication previously granted under accelerated approval for patients with mUC with susceptible FGFR3 or FGFR2 alterations after prior platinum-containing chemotherapy. <Read More> Casgevy™ (exagamglogene autotemcel) Suspension for Intravenous Infusion – New Label Expansion – January 16, 2024 – Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced that the U.S. Food and Drug Administration (FDA) has approved Casgevy™ (exagamglogene autotemcel [exa-cel]), a CRISPR/Cas9 gene-edited cell therapy, for the treatment of transfusion-dependent beta thalassemia (TDT) in patients 12 years and older. “On the heels of the historic FDA approval of Casgevy™ for sickle cell disease, it is exciting to now secure approval for TDT well ahead of the PDUFA date,” said Reshma Kewalramani, M.D., Chief Executive Officer and President of Vertex. “TDT patients deserve new, potentially curative treatment options, and we look forward to bringing Casgevy™ to eligible patients who are waiting.” <Read More>

New Indication/Dosage/Formulation Approval

No new update.

New Drug Shortage

January 12, 2024

• Lisdexamfetamine Dimesylate Capsule (Currently in Shortage)

Updated Drug Shortage

January 22, 2024

• Amoxicillin Powder, For Suspension (Currently in Shortage)

• Conivaptan Hydrochloride Injection (Discontinuation)

• Heparin Sodium Injection (Currently in Shortage)

• Multi-Vitamin Infusion (Adult and Pediatric) Injection (Resolved)

• Rocuronium Bromide Injection (Currently in Shortage)

January 19, 2024

• Bupivacaine Hydrochloride Injection (Currently in Shortage)

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

• Dobutamine Hydrochloride Injection (Currently in Shortage)

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

• Fentanyl Citrate 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)

• Mannitol 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 14.6% Injection (Currently in Shortage)

• Sodium Chloride 23.4% Injection (Currently in Shortage)

• Sufentanil Citrate Injection (Currently in Shortage)

• Tirzepatide Injection (Currently in Shortage)

January 18, 2024

• Bupivacaine Hydrochloride Injection (Currently in Shortage)

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

• Chloroprocaine Hydrochloride Injection (Currently in Shortage)

• Dexamethasone Sodium Phosphate Injection (Currently in Shortage)

• Dextrose Monohydrate Injection (Currently in Shortage)

• Dopamine Hydrochloride Injection (Currently in Shortage)

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

• Fentanyl Citrate Injection (Currently in Shortage)

• Fludarabine Phosphate Injection (Currently in Shortage)

• Gentamicin Sulfate Injection (Currently in Shortage)

• Heparin Sodium Injection (Currently in Shortage)

• Hydromorphone Hydrochloride Injection (Currently in Shortage)

• Ketorolac Tromethamine Injection (Currently in Shortage)

• Lidocaine Hydrochloride Injection (Currently in Shortage)

• Mepivacaine Hydrochloride Injection (Currently in Shortage)

• Methotrexate Sodium Tablet (Currently in Shortage)

• Rocuronium Bromide Injection (Currently in Shortage)

• Ropivacaine Hydrochloride 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 Phosphate, Dibasic, Anhydrous, Sodium Phosphate, Monobasic, Monohydrate Injection (Currently in Shortage)

• Sucralfate Tablet (Currently in Shortage)

• Vinblastine Sulfate Injection (Currently in Shortage)

January 17, 2024

• Albuterol Sulfate Solution (Currently in Shortage)

• Azacitidine Injection (Currently in Shortage)

• Capecitabine Tablet (Currently in Shortage)

• Erythromycin Ointment (Currently in Shortage)

• Methotrexate Sodium Injection (Currently in Shortage)

• Sterile Water Injection (Currently in Shortage)

January 16, 2024

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

• Lisdexamfetamine Dimesylate Capsule (Currently in Shortage)

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

• Penicillin G Benzathine Injection (Currently in Shortage)

January 15, 2024

• Amphetamine Aspartate Monohydrate, Amphetamine Sulfate,

• Carboplatin Injection (Currently in Shortage)

• Cisplatin Injection (Currently in Shortage)

• Ketamine Hydrochloride Injection (Currently in Shortage)

• Sodium Bicarbonate Injection (Currently in Shortage)

• Sodium Chloride 0.9% Irrigation (Currently in Shortage)

• Sodium Pyrophosphate Injection (Currently in Shortage)

New Drug Recall and Safety Alerts

Multiple Eyedrops by Kilitch Healthcare India Limited - New Voluntary Recall Correction – January 22, 2024 – Kilitch Healthcare India Limited is issuing an amendment in the last Nationwide press release dated November 13, 2023 issued for nationwide recall of various eye drops. There are corrections in product NDC No for the below mentioned products. These products were distributed nationwide to wholesalers, retailers, and via the product distributor, Velocity Pharma LLC. <Read More>

New Generic/Biosimilar Approval and Launch

No new update.

Clinical and Pharmacy News

All it Takes is a Conversation: Deprescribing Benzodiazepines in Older Adults – January 19, 2024 – Benzodiazepines have proven effective in managing anxiety and insomnia, but they heighten risk of falls, cognitive impairment, functional decline, and mortality among older adults. Prescribing medications and intensifying therapeutic regimens are often at the forefront of optimizing patient care. However, patients can accumulate a plethora of medications and such polypharmacy can cause adverse effects and even, potentially, the development of new conditions and diseases. Benzodiazepines have proven effective in managing anxiety and insomnia, but they heighten risk of falls, cognitive impairment, functional decline, and mortality among older adults, as well as avoidable hospitalizations. Regardless of their risks and the availability of safer first-line treatments for anxiety and insomnia, benzodiazepines are still one of the most commonly prescribed medication classes in the United States, being given to almost 10% of Medicare beneficiaries. <Read More> How Specialty Pharmacies Can Increase Access Through Patient Financing – January 16, 2024 – More than 4 in 10 Americans are concerned that prescription drug costs will lead to bankruptcy or debt.1 One-third of respondents to the same study said the cost of their prescription medications rose last year. For those living with rare, chronic, or complex diseases who require specialty pharmaceuticals, cost-related concerns can be even greater. Specialty medications are costly, have a more complex benefit structure, and follow strict payer utilization management parameters that complicate patients’ ability to access prescribed therapy. For these reasons, it’s essential that health care providers across the patient journey demystify the costs of treatment and provide solutions to overcome the financial barriers, helping to ensure patients can access the care and treatments they want and need. <Read More> Study Finds High HIV Viral Loads Associated With Higher Recombination Rates, May Influence Viral Evolution – January 12, 2024 – According to research published in Molecular Biology and Evolution, HIV populations in people with higher viral loads also have higher rates of viral recombination. In effect, it is easier for the virus to diversify when there are more viral loads of HIV in the blood. Due to HIV’s high rate of recombination—which allows the exchange of genetic information across strains of the virus and drives the evolution of HIV—it has been difficult to combat the virus. Further, recombination is an evolutionary driver and allows organisms to remove destructive mutations and instead combine helpful ones. According to the authors, understanding the factors that influence recombination rates in HIV can help broadly reveal the potential effects that recombination has on the viral evolution. <Read More> Ninety Percent of Pain Patients Have Trouble Filling Opioid Prescriptions – January 11, 2024 – Nine out of ten pain patients with an opioid prescription in the United States experienced delays or problems in the past year getting their prescription filled at a pharmacy, according to a large new survey by Pain News Network.  Nearly 20% of patients were not able to get their opioid medication, even after contacting multiple pharmacies. Over 2,800 pain patients participated in PNN’s online survey. Many were so frustrated with pharmacists being unable or unwilling to fill their opioid prescriptions that they turned to other substances for pain relief or contemplated suicide. “My medication helps my pain be at a level I can tolerate. When I can't get it, I honestly feel like ending my life due to the pain. I wish they'd stop to realize there are those of us with a legitimate need,” one patient told us. <Read More> CVS Will Close Some Target Pharmacy Locations – January 11, 2024 – CVS will close dozens of pharmacies located inside of Target stores in early 2024, a company spokesperson said on Thursday. The closures come as retail pharmacy chains in the US face increasing difficulties with their prescriptions business, workforces and more. CVS will shutter the pharmacies between February and April of this year as part of the Rhode Island-based company’s plan to space out stores and pharmacies more, said Amy Thibault, spokesperson for CVS Pharmacy, in an email to CNN. The closures are “based on our evaluation of changes in population, consumer buying patterns and future health needs to ensure we have the right pharmacy format in the right locations for patients,” she said. <Read More> AMCP Report Illustrates Benefits of Managed Care Pharmacy – January 10, 2024 – Due to the increasing prevalence of managed care pharmacies (MCPs) and the lack of widespread understanding of their benefits, the Academy of Managed Care Pharmacy (AMCP) released a report that aims to explain how delivering pharmacy benefits through a managed care organization (MCO) improves patient health, titled “Access, Affordability, and Outcomes: The Value of Managed Care Pharmacy.” Most people in the United States with private health insurance have their pharmacy benefits managed by an insurer through an MCP. Furthermore, MCP is the dominant method for Medicaid recipients to receive prescription benefits and is growing among Medicare patients. In 2022, 45% of Medicare patients were enrolled in an MCP Medicare Advantage Plan. <Read More> Medicare Reimbursement Hits New Low – January 10, 2024 – Medicare historically reimburses hospitals below the cost of providing care to patients, but payments to hospitals fell to a record low in 2022, according to new data provided by the American Hospital Association. Four things to know:  1) An AHA analysis published Jan. 10 shows that Medicare paid 82 cents for every dollar hospitals spent on care for Medicare patients in 2022 — the most recent year for which data is available, 2) Medicare underpayments to hospitals hit $99.2 billion in 2022, almost two and a half times the amount in 2012, according to the report… <Read More>

340B in the News

Tracking Administrative Complexity Within the 340B Drug Pricing Program – January 16, 2024 – Part of the Public Health Service Act of 1992, the 340B Drug Pricing Program lowers drug costs and increases revenues for safety-net health care providers by allowing them to pay heavily discounted prices for prescription drugs, but get reimbursed at full cost. With revenues from the discounted drugs, these safety-net providers can offer discounts on drugs for their patients while also enhancing their care offerings to help achieve the 340B program's goal of "reaching more eligible patients and providing more comprehensive services." The 340B program has grown substantially in the last three decades to include more eligible hospitals and a dramatic expansion in the number of pharmacies contracted via the program to dispense drugs. In the first study of its kind, published in Health Affairs Scholar, the University of Minnesota School of Public Health (SPH) sheds light on a previously unexamined area of the 340B program's growth: third-party administrators (TPAs). <Read More> How Hospitals Hijacked a Drug Discount Program for the Poor – January 10, 2024 – Corporate greed is a powerful motivator. When our lawmakers draft legislation, they really ought to have a special committee to evaluate how corporations might exploit it. No such committee exists, though. And that’s one reason a program enacted in 1992 to give poor and underserved populations better access to costly prescription drugs has turned into a multibillion-dollar boondoggle for hospital mega-chains. It’s high time for Congress to restore the 340B drug discount program to its intended purpose. The 340B program allows hospitals, specified clinics, and other “safety net” providers to purchase outpatient prescription drugs at significant discounts. Theoretically, providers could pass along these savings to their underserved patients by charging them less for medications — or reinvesting in services and facilities for those in need. But nothing requires them to do that. So, very often, they don’t. Instead, they use the discounts to pad their profits. <Read More> How Drug Manufacturers Can Mitigate Trends in Revenue Leakage – January 9, 2024 – The Gross-to-Net (GTN) gap for drug manufacturers in 2022 was $223 billion, a 33.5% increase from 2018, when the total sum of manufacturer GTN reductions for patent-protected, brand name drugs was $167 billion. Misapplied discounts are a major contributor to this growing revenue leakage, which puts financial pressure on drug manufacturers and makes it more difficult to keep down drug prices. This trend isn’t likely to abate soon: Multiple factors are aligning to intensify the impact of misapplied discounts on drug manufacturers over the next two years. For starters, the 340B program, created by Congress more than three decades ago to make drug rebates mandatory, has grown in popularity since the federal government in 2010 allowed an unlimited number of contract pharmacies to participate. <Read More>

New Drug/Vaccine Approval

No new update.

New Indication/Dosage/Formulation Approval

Yescarta® (axicabtagene ciloleucel) Suspension for Intravenous Infusion – New Label Expansion – January 30, 2024 – Kite, a Gilead Company (Nasdaq: GILD), announced that the U.S. Food and Drug Administration (FDA) has approved a manufacturing process change resulting in a shorter manufacturing time for Yescarta® (axicabtagene ciloleucel). With this approval, Kite’s median turnaround time (TAT) in the U.S. is anticipated to be reduced from 16 days to 14 days. <Read More> Gammagard Liquid® (immune globulin infusion (human)) Solution – New Label Expansion – January 26, 2024 – Takeda (TSE:4502/NYSE:TAK) announced that the U.S. Food and Drug Administration (FDA) has approved Gammagard Liquid® [Immune Globulin Infusion (Human) 10% solution] as an intravenous immunoglobulin (IVIG) therapy to improve neuromuscular disability and impairment in adults with chronic inflammatory demyelinating polyneuropathy (CIDP). It can be used as induction therapy, which includes an induction dose followed by maintenance doses. For treatment of CIDP, Gammagard Liquid® has not been studied in immunoglobulin-naive patients nor as maintenance therapy for periods longer than six months. <Read More> Dupixent® (dupilumab) Injection – New Label Expansion – January 25, 2024 – Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi announced that the U.S. Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) for the treatment of pediatric patients aged 1 to 11 years, weighing at least 15 kg, with eosinophilic esophagitis (EoE). Dupixent® is now the first and only medicine approved in the U.S. specifically indicated to treat these patients. This approval expands the initial FDA approval for EoE in May 2022 for patients aged 12 years and older, weighing at least 40 kg. 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> Zynrelef® (bupivacaine and meloxicam) Injection – New Label Expansion – January 23, 2024 – Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company, announced that the U.S. Food and Drug Administration (the "FDA") has approved its supplemental New Drug Application ("NDA") for Zynrelef® (bupivacaine and meloxicam) extended-release solution to expand the indication for soft tissue and orthopedic surgical procedures including foot and ankle, and other procedures in which direct exposure to articular cartilage is avoided. Zynrelef® was previously approved for foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures in adults. <Read More>

New Drug Shortage

February 06, 2024

• Carbamazepine Capsule, Extended Release (Discontinuation)

• Mesalamine Tablet, Delayed Release (Discontinuation)

February 01, 2024

• DOXYCYCLINE HYCLATE CAPSULE (Discontinuation)

January 30, 2024

• Erythromycin Ointment (Currently in Shortage)

• Triazolam Tablet (Discontinuation)

January 26, 2024

• Riluzole Oral Suspension (Currently in Shortage)

• Zolpidem Tartrate Tablet, Extended Release (Discontinuation)

January 24, 2024

• Lidocaine Hydrochloride Solution (Currently in Shortage)

Updated Drug Shortage

February 06, 2024

• Amoxapine Tablet (Currently in Shortage)

• Azacitidine Injection (Currently in Shortage)

• Capecitabine Tablet (Currently in Shortage)

• Cisplatin Injection (Currently in Shortage)

• Clonazepam Tablet (Currently in Shortage)

• Disopyramide Phosphate Capsule (Currently in Shortage)

• Fludarabine Phosphate Injection (Currently in Shortage)

• Lisdexamfetamine Dimesylate Capsule (Currently in Shortage)

• Methotrexate Sodium Injection (Currently in Shortage)

• Methotrexate Sodium Tablet (Currently in Shortage)

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

• Neomycin Sulfate Tablet (Currently in Shortage)

• Sucralfate Tablet (Currently in Shortage)

• Sulfasalazine Tablet (Currently in Shortage)

February 05, 2024

• Capecitabine Tablet (Currently in Shortage)

• Dulaglutide Injection (Currently in Shortage)

• Liraglutide Injection (Currently in Shortage)

• Methotrexate Sodium Injection (Currently in Shortage)

• Methotrexate Sodium Injection (Discontinuation)

• Methotrexate Sodium Tablet (Currently in Shortage)

• Methyldopa Tablet, Film Coated (Discontinuation)

February 03, 2024

• Amino Acid Injection (Currently in Shortage)

• Dextrose Monohydrate Injection (Currently in Shortage)

• Dextrose Monohydrate, Lidocaine Hydrochloride Anhydrous Injection (Currently in Shortage)

• Mannitol 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)

February 02, 2024

• Lisdexamfetamine Dimesylate Capsule (Currently in Shortage)

February 01, 2024

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

• Atropine Sulfate Injection (Currently in Shortage)

• Chloroprocaine Hydrochloride Injection (Currently in Shortage)

• Dextrose Monohydrate Injection (Currently in Shortage)

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

• Flurazepam Hydrochloride Capsule (Currently in Shortage)

• Gentamicin Sulfate Injection (Currently in Shortage)

• Hydroxypropyl Cellulose (1600000 Wamw) Insert (Currently in Shortage)

• Lidocaine Hydrochloride Solution (Currently in Shortage)

• Lisdexamfetamine Dimesylate Capsule (Currently in Shortage)

• Mannitol Injection (Currently in Shortage)

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

• Midazolam Hydrochloride Injection (Currently in Shortage)

• Nitroglycerin Injection (Currently in Shortage)

• Potassium Chloride Injection (Currently in Shortage)

• Rocuronium Bromide 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)

• Sucralfate Tablet (Currently in Shortage)

• Sulfasalazine Tablet (Currently in Shortage)

• Valproate Sodium Injection (Currently in Shortage)

• Vecuronium Bromide Injection (Currently in Shortage)

• Vinblastine Sulfate Injection (Currently in Shortage)

January 31, 2024

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

New Drug Recall and Safety Alerts

Zenzedi® (dextroamphetamine sulfate tablets, USP) 30 mg by Azurity Pharmaceuticals, Inc. - New Voluntary Recall – January 25, 2024 – Azurity Pharmaceuticals, Inc. is voluntarily recalling one (1) lot (F230169A) of Zenzedi® CII (dextroamphetamine sulfate tablets, USP) 30 mg to the consumer level. The product is being recalled due to a report from a pharmacist in Nebraska who opened a bottle of Zenzedi® 30 mg tablets and found tablets of Carbinoxamine Maleate, an antihistamine drug. Upon learning of the incident, the manufacturer opened a product complaint and an investigation followed. <Read More> Robitussin Honey CF Max Day Adult and Robitussin Honey CF Max Nighttime Adult Products by Haleon – New Voluntary Recall – January 24, 2024 – Haleon is voluntarily recalling eight lots of Robitussin Honey CF Max Day Adult and Robitussin Honey CF Max Nighttime Adult to the consumer level. The product is being recalled due to microbial contamination. <Read More>

New Generic/Biosimilar Approval and Launch

No new update.

Clinical and Pharmacy News

FDA Revises Letter of Authorization for the Emergency Use Authorization for Paxlovid™ – January 29, 2024 – The FDA is announcing a revision to the Paxlovidä emergency use authorization (EUA), stating that Paxlovid™ manufactured and labeled in accordance with the EUA (EUA-labeled Paxlovid™) currently in U.S. distribution will remain authorized for use through the labeled or extended expiration date, as applicable, or through March 8, 2024, whichever is earlier. <Read More> US Pharmacy Benefit Lobby Group Ramps Up Spending as Lawmakers Close in – January 25, 2024 – As U.S. pharmacy benefit companies face scrutiny from lawmakers and regulators, the main group representing them in Washington has nearly doubled its lobbying spend to over $15 million in 2023, a Reuters review of congressional disclosures shows. That puts them behind only the $27 million spent by the Pharmaceutical Research and Manufacturers of America (PhRMA), the usual No. 1 and main lobby group for drugmakers that has tried to deflect criticism for high drug prices by blaming the industry's middlemen, the pharmacy benefit managers (PBMs). <Read More>

340B in the News

Senators Seek Stakeholder Feedback on Draft 340B Legislation – February 2, 2024 – A bipartisan group of senators Feb. 2 released for stakeholder feedback a discussion draft of legislation to clarify in statute Congress’ intent for the 340B program to help safety net providers maintain, improve and expand patient access to health care services by requiring drug manufacturers that participate in Medicaid and Medicare Part B to provide discounts and rebates to covered entities that serve a disproportionate share of low-income and underserved patients. <Read More>

New Drug/Vaccine Approval

Eohilia™ (budesonide) Oral Suspension – New Drug Approval – February 9, 2024 – Takeda (TSE:4502/NYSE:TAK) announced that the U.S. Food and Drug Administration (FDA) has approved Eohilia™ (budesonide oral suspension), the first and only FDA-approved oral therapy for people 11 years and older with eosinophilic esophagitis (EoE). It will be available in 2 mg/10 mL convenient, single-dose stick packs by the end of February. Eohilia™ is a corticosteroid indicated for 12 weeks of treatment in patients 11 years and older with EoE. Developed specifically for EoE, Eohilia™’s novel formulation of budesonide confers thixotropic properties – flowing more freely when shaken and returning to a more viscous state when swallowed. <Read More>

New Indication/Dosage/Formulation Approval

No new update.

New Drug Shortage

February 07, 2024

• Leucovorin Calcium Injection (Currently in Shortage)

February 06, 2024

• Carbamazepine Capsule, Extended Release (Discontinuation)

• Lanthanum Carbonate Tablet, Chewable (Discontinuation)

• Mesalamine Tablet, Delayed Release (Discontinuation)

Updated Drug Shortage

February 13, 2024

• Gentamicin Sulfate Injection (Discontinuation)

February 09, 2024

• Atropine Sulfate Injection (Currently in Shortage)

• Bupivacaine Hydrochloride Injection (Currently in Shortage)

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

• Carboplatin Injection (Currently in Shortage)

• Clindamycin Phosphate Injection (Currently in Shortage)

• Cytarabine Injection (Currently in Shortage)

• Dexmedetomidine Hydrochloride Injection (Currently in Shortage)

• Dextrose Monohydrate Injection (Currently in Shortage)

• Diltiazem Hydrochloride Injection (Currently in Shortage)

• Dobutamine Hydrochloride Injection (Currently in Shortage)

• Dopamine Hydrochloride Injection (Currently in Shortage)

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

• Epinephrine Injection (Currently in Shortage)

• Etomidate Injection (Currently in Shortage)

• Fentanyl Citrate Injection (Currently in Shortage)

• Furosemide 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)

• Mannitol Injection (Currently in Shortage)

• Methotrexate Sodium Injection (Currently in Shortage)

• Methotrexate Sodium Tablet (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)

• Potassium Acetate Injection (Currently in Shortage)

• Potassium Chloride Injection (Currently in Shortage)

• Rocuronium Bromide 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 14.6% Injection (Currently in Shortage)

• Sodium Chloride 23.4% Injection (Currently in Shortage)

• Sodium Phosphate, Dibasic, Anhydrous, Sodium Phosphate, Monobasic, Monohydrate Injection (Currently in Shortage)

• Somatropin Injection (Currently in Shortage)

• Sterile Water Injection (Currently in Shortage)

• Sucralfate Tablet (Currently in Shortage)

• Sufentanil Citrate Injection (Currently in Shortage)

February 08, 2024

• Dextrose Monohydrate Injection (Currently in Shortage)

• Epinephrine Injection (Currently in Shortage)

• Lisdexamfetamine Dimesylate Capsule (Currently in Shortage)

• Lisdexamfetamine Dimesylate Tablet, Chewable (Currently in Shortage)

February 07, 2024

• Azacitidine Injection (Currently in Shortage)

• Dacarbazine Injection (Currently in Shortage)

• Fentanyl Citrate Injection (Currently in Shortage)

• Leucovorin Calcium Injection (Currently in Shortage)

• Rifampin Injection (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

Sky High Prescription Drug Prices Have Md. Legislators Looking for Consumer Relief – February 12, 2024 – Skyrocketing prescription drug prices are forcing Maryland legislators to look at several solutions to try to bring those costs down for citizens. One man who testified before Maryland’s Senate Finance Committee last week said he has to pay around $800 for just an ounce of medication. “How many of us, like me, are making decisions whether to eat, heat or treat a condition like I have?” he told the committee. “It’s neurodegenerative and there’s no cure.” Patients like him voiced their support for a bill that may one day limit the pricing on specific medications. Introduced in both chambers of the General Assembly, the Lowering Prescription Drug Costs for All Marylanders Act of 2024 would allow the state’s Prescription Drug Affordability Board to set up “upper payment limits” for drugs that they deem unaffordable. <Read More> New AAD Acne Guidelines Warn About High Cost, Access to New Treatments – February 5, 2024 – The American Academy of Dermatology has issued updated guidelines for the treatment of acne that strongly recommend many of the mainstays of acne care but also boost some new expensive treatments that may challenge payer coverage policies. The guidelines include some cautionary language about the use of systemic antibiotics leading to antibiotic resistance and other antibiotic-associated complications, noting that in 2021 dermatologists prescribed more oral antibiotics per clinician than any other specialty group and that most of the antibiotics were for acne treatment. <Read More> Group of Transparent Pharmacy Benefit Managers Form Transparency-Rx to Advocate for Clarity and Reform in Pricing of Prescription Drugs – January 26, 2024 – Increased transparency that lets consumers see prices charged by hospitals, physicians, and clinical laboratories in advance of service is an important goal of healthcare policymakers and self-insured employers. But greater transparency has yet to affect how prescription drugs are first priced, marked up, and charged to the final purchasers. Now a group within the pharmaceutical industry has issued a call for greater transparency in the pricing of prescription drugs. A number of smaller Pharmacy Benefit Managers (PBMs) have formed a coalition against the often confusing and overly complex pricing of prescription drugs in hopes that their efforts will give healthcare consumers more clarity when it comes to comparison shopping for pharmaceuticals. <Read More> Drugmakers Hiking Prices for More Than 700 Medications, Including Ozempic® and Mounjaro™ – January 18, 2024 – Pharmaceutical companies are hiking prices for more than 700 medications, including popular weight-loss drugs Ozempic® and Mounjaro™, industry research shows. The average price increase at year start was about 4.5%, the analysis from 46 Brooklyn found. That represents a slightly slower pace compared with the five prior years, when drug prices rose about 5% each year on average, the data shows. <Read More> Implementing Technological Workflow May Usher in New Era of Pharmacy – January 9, 2024 – Placing telepharmacy at the forefront of outdated workflows could transform the traditional pharmacy setting. Everyone knows the statistic: Pharmacists are considered the most accessible health care professional. Everyone also knows that pharmacists are experiencing more burnout than ever before. Although external factors such as the COVID-19 pandemic have contributed to this burnout, factors within the pharmacy, such as outdated workflows that incorporate manual practices that increase workload and cut into pharmacists’ valuable time, are also to blame. Incorporating telepharmacy models into these outdated pharmacy workflows may mitigate the harms associated with burnout and create a more efficient, safe, and lucrative pharmacy setting. <Read More>

340B in the News

Gang of Six Introduces Historic 340B “Discussion Draft” Legislation – February 9, 2024 – On February 2, 2024, the “gang of six”—a bipartisan group of six senators who have traditionally championed reforms to the 340B program—introduced a discussion draft of a bill that would modify the program that provides safety net providers with access to low-cost medications from participating manufacturers. The 340B statute has not been modified since 2010. If enacted, the bill would codify for the first time contract pharmacy and child site arrangements in the 340B statute, but would do so in exchange for certain program integrity reforms. As a discussion draft, the bill includes placeholders, to be addressed in response to certain requests for information (RFIs) released alongside the draft bill. <Read More> 

New Drug/Vaccine Approval

Amtagvi™ (lifileucel) Suspension for Intravenous Infusion –New Orphan Drug Approval  –February 16, 2024 – The U.S. Food and Drug Administration approved Amtagvi™ (lifileucel), the first cellular therapy indicated for the treatment of adult patients with a type of skin cancer (melanoma) that is unable to be removed with surgery (unresectable) or has spread to other parts of the body (metastatic) that previously has been treated with other therapies (a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor). <Read More>  Aurlumyn™ (iloprost) Injection – New Orphan Drug Approval – February 13, 2024 – The U.S. Food and Drug Administration approved Aurlumyn™ (iloprost) injection to treat severe frostbite in adults to reduce the risk of finger or toe amputation. “This approval provides patients with the first-ever treatment option for severe frostbite,” said Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiology and Nephrology in the FDA’s Center for Drug Evaluation and Research. “Having this new option provides physicians with a tool that will help prevent the lifechanging amputation of one’s frostbitten fingers or toes.” <Read More>

New Indication/Dosage/Formulation Approval

Biktarvy® (bictegravir, emtricitabine and tenofovir alafenamide) Tablets – New Label Expansion – February 23, 2024 – Gilead Sciences, Inc. (Nasdaq: GILD) announced the U.S. Food and Drug Administration (FDA) approved a new, expanded indication for Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) to treat people with HIV (PWH) who have suppressed viral loads with known or suspected M184V/I resistance, a common form of treatment resistance. HIV treatment resistance is permanent and irreversible, which can jeopardize future treatment options for PWH. The M184V/I resistance mutation has been found to be present in a range (22-63%) of PWH with pre-existing resistance to nucleoside reverse transcriptase inhibitors (NRTIs) across various HIV subtypes. <Read More> Imbruvica® (ibrutinib) Capsules, Tablets and Oral Suspension – New Label Expansion – February 22, 2024 – Johnson & Johnson, in collaboration with its alliance partner, Pharmacyclics LLC, an AbbVie Company, announced that the U.S. Food and Drug Administration (FDA) has approved a label expansion for Imbruvica® (ibrutinib) with an oral suspension formulation for adult patients in the treatment of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL); Waldenström’s macroglobulinemia (WM); and chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy. “Some patients may have trouble swallowing medications, adding another layer of complexity to their treatment journey,” said Lisa Nodzon, PhD, ARNP, AOCNP at Moffitt Cancer Center. “Having multiple formulations of Imbruvica® offers prescribers another option when treating adults with CLL/SLL, WM, or cGVHD, which could make a difference in their daily lives.” <Read More> Tecvayli® (teclistamab-cqyv) Injection – New Label Expansion – February 20, 2024 – Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Tecvayli® (teclistamab-cqyv) for a reduced dosing frequency of 1.5 mg/kg every two weeks (Q2W) in patients with relapsed or refractory multiple myeloma (RRMM) who have achieved and maintained a complete response (CR) or better for a minimum of six months.1There is a continued unmet need for patients with multiple myeloma and this approval allows increased flexibility in dosing schedule for appropriate patients with a weight-based regimen. <Read More> Xolair® (omalizumab) Injection – New Label Expansion – February 16, 2024 – The U.S. Food and Drug Administration approved Xolairâ (omalizumab) injection for immunoglobulin E-mediated food allergy in certain adults and children 1 year or older for the reduction of allergic reactions (Type I), including reducing the risk of anaphylaxis, that may occur with accidental exposure to one or more foods. Patients who take Xolair® must continue to avoid foods they are allergic to. Xolair® is intended for repeated use to reduce the risk of allergic reactions and is not approved for the immediate emergency treatment of allergic reactions, including anaphylaxis. Xolair® was originally approved in 2003 for the treatment of moderate to severe persistent allergic asthma in certain patients. Xolair® is also approved to treat chronic spontaneous urticaria and chronic rhinosinusitis with nasal polyps in certain patients. <Read More> Tagrisso® (osimertinib) Tablets – New Label Expansion – February 16, 2024 – AstraZeneca’s Tagrisso® has been approved in the US for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC). The approval following a Priority Review by the Food and Drug Administration (FDA) was based on the results from the FLAURA2 Phase III trial published in The New England Journal of Medicine. Tagrisso® with the addition of chemotherapy reduced the risk of disease progression or death by 38% compared to Tagrisso® monotherapy which is the 1st-line global standard of care (hazard ratio [HR] 0.62; 95% confidence interval [CI] 0.49-0.79; p<0.0001). Median progression-free survival (PFS) by investigator assessment was 25.5 months for patients treated with Tagrisso® plus chemotherapy, an 8.8-month improvement versus Tagrisso® monotherapy (16.7 months). <Read More> Tepmetko® (tepotinib) Tablets – New Label Expansion – February 15, 2024 – The Food and Drug Administration granted traditional approval to tepotinib (Tepmetko®, EMD Serono, Inc.) for adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations. Tepotinib was previously granted accelerated approval for this indication on February 3, 2021, based on initial overall response rate (ORR) and duration of response (DOR) in the VISION trial (NCT02864992), a multicenter, non-randomized, open-label, multicohort study. <Read More> Onivyde® (irinotecan liposomal) Injection – New label Expansion – February 13, 2024 – Ipsen (Euronext: IPN; ADR: IPSEY) announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application for Onivyde® (irinotecan liposome injection) plus oxaliplatin, fluorouracil and leucovorin (NALIRIFOX) as a first-line treatment in adults living with metastatic pancreatic adenocarcinoma (mPDAC). This is the second approval for an Onivyde® regimen in mPDAC, following the FDA’s approval in 2015 of Onivyde® plus fluorouracil and leucovorin following disease progression with gemcitabine-based therapy. <Read More>

New Drug Shortage

February 28, 2024

• Phenytoin Oral Suspension (Discontinuation)

February 23, 2024

• Melphalan Tablet (Discontinuation)

February 14, 2024

• Rocuronium Bromide Injection (Currently in Shortage)

February 13, 2024

• Morphine Sulfate Injection (Currently in Shortage)

Updated Drug Shortage

February 27, 2024

• Atropine Sulfate Injection (Currently in Shortage)

• Bupivacaine Hydrochloride Injection (Currently in Shortage)

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

• Carboplatin Injection (Currently in Shortage)

• Clindamycin Phosphate Injection (Currently in Shortage)

• Cytarabine Injection (Currently in Shortage)

• Dexmedetomidine Hydrochloride Injection (Currently in Shortage)

• Dextrose Monohydrate Injection (Currently in Shortage)

• Disopyramide Phosphate Capsule (Currently in Shortage)

• Dobutamine Hydrochloride Injection (Currently in Shortage)

• Dopamine Hydrochloride Injection (Currently in Shortage)

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

• Epinephrine Injection (Currently in Shortage)

• Etomidate Injection (Currently in Shortage)

• Fentanyl Citrate Injection (Currently in Shortage)

• Furosemide Injection (Currently in Shortage)

• Gentamicin Sulfate 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)

• Ketorolac Tromethamine 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)

• Metronidazole Injection (Currently in Shortage)

• Midazolam Hydrochloride Injection (Currently in Shortage)

• Morphine Sulfate Injection (Currently in Shortage)

• Penicillin G Benzathine Injection (Currently in Shortage)

• Potassium Acetate Injection (Currently in Shortage)

• Potassium Chloride Injection (Currently in Shortage)

• Quinapril Hydrochloride Tablet (Currently in Shortage)

• Quinapril/Hydrochlorothiazide Tablet (Currently in Shortage)

• Rocuronium Bromide 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 0.9%0 Injection (Currently in Shortage)

• Sodium Chloride 14.6% Injection (Currently in Shortage)

• Sodium Chloride 23.4% Injection (Currently in Shortage)

• Sodium Phosphate, Dibasic, Anhydrous, Sodium Phosphate, Monobasic, Monohydrate Injection (Currently in Shortage)

• Somatropin Injection (Currently in Shortage)

• Sterile Water Injection (Currently in Shortage)

• Sufentanil Citrate Injection (Currently in Shortage)

• Sulfasalazine Tablet (Currently in Shortage)

• Trimethobenzamide Hydrochloride Capsule (Resolved)

February 26, 2024

• Flurazepam Hydrochloride Capsule (Currently in Shortage)

• Methotrexate Sodium Tablet (Currently in Shortage)

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

• Technetium TC-99M Pyrophosphate Kit Injection (Currently in Shortage)

February 23, 2024

• Methamphetamine Hydrochloride Tablet (Currently in Shortage)

February 22, 2024

• Atropine Sulfate Injection (Currently in Shortage)

• Bumetanide Injection (Currently in Shortage)

• Cefotaxime Sodium Injection (Currently in Shortage)

• Cisplatin Injection (Currently in Shortage)

• Dacarbazine Injection (Currently in Shortage)

• Dexmedetomidine Hydrochloride Injection (Currently in Shortage)

• Digoxin Injection (Currently in Shortage)

• Diltiazem Hydrochloride Injection (Currently in Shortage)

• Dopamine Hydrochloride Injection (Currently in Shortage)

• Etomidate Injection (Currently in Shortage)

• Ketamine Hydrochloride Injection (Currently in Shortage)

• Leucovorin Calcium Injection (Currently in Shortage)

• Lidocaine Hydrochloride Injection (Currently in Shortage)

• Lorazepam Injection (Currently in Shortage)

• Methotrexate Sodium Injection (Currently in Shortage)

• Midazolam Hydrochloride Injection (Currently in Shortage)

• Promethazine Hydrochloride Injection (Currently in Shortage)

• Propranolol Hydrochloride Injection (Currently in Shortage)

• Rocuronium Bromide Injection (Currently in Shortage)

February 21, 2024

• Conivaptan Hydrochloride Injection (Currently in Shortage)

New Drug Recall and Safety Alerts

Equate Lubricant Eye Ointment, Equate Stye Lubricant Eye Ointment, CVS Health Lubricant Eye Ointment, Lubricant PM Ointment by Brassica Pharma Pvt. Ltd. – New Voluntary Recall – February 22, 2024 - Brassica Pharma Pvt. Ltd. is voluntarily recalling Eye Ointment products listed in the table below with expiration date ranging from February 2024 to September 2025. The products are being recalled due to lack of sterility assurance at the facility noted during an inspection conducted by the Food and Drug Administration (FDA). <Read More>

New Generic/Biosimilar Approval and Launch

Simlandi™ (adalimumab-ryvk) Injection – New Biosimilar Approval – February 23, 2024 – Alvotech (NASDAQ: ALVO) and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), announced that the U.S. Food and Drug Administration (FDA) has approved Simlandi™ (adalimumab-ryvk) injection, as an interchangeable biosimilar to Humira®, for the treatment of adult rheumatoid arthritis, juvenile idiopathic arthritis, adult psoriatic arthritis, adult ankylosing spondylitis, Crohn’s disease, adult ulcerative colitis, adult plaque psoriasis, adult hidradenitis suppurativa and adult uveitis. In 2023, Humira® was one of the highest-grossing pharmaceutical products in the world, with sales in the U.S. of nearly $12.2 billion. Teva is Alvotech’s strategic partner for the exclusive commercialization of Simlandi™ in the United States. <Read More>

Clinical and Pharmacy News

Local Pharmacy Feeling Impact of Nationwide Cyberattack – February 27, 2024 – Pharmacies across the nation and in St. Joseph are working to fill essential medications after a cyberattack last Wednesday disrupted data transmission lines between insurance companies and pharmacies. The cybersecurity attack that took place on a major health tech platform, Change Healthcare, has complicated the process of billing through insurance companies, and local pharmacies are feeling the impact. JulieMarie Nickelson, a registered pharmacist at Roger’s Pharmacy, said when the cyber issue first happened, they experienced nearly 500 claims a day not going through for patients. “It’s improved since last Wednesday, but it’s definitely not resolved yet,” Nickelson said. There are many coupons that aren’t working; we have insurances where some claims are going through, but not others. So, we’re kind of at the mercy of what we call a ‘switch program,’ which is basically the intermediary between the pharmacy and the insurance company.” <Read More> The Change Healthcare Cyberattack is Still Impacting Pharmacies. It’s a Bigger Deal Than You Think – February 26, 2024 - Pharmacies across the United States are still grappling with substantial disruptions following a cyberattack on UnitedHealth’s technology unit, Change Healthcare, as reported by multiple pharmacy chains through official statements and on various social media platforms. The attack led to a nationwide outage of a network designed to communicate data between healthcare providers and insurance companies. According to a filing last Thursday with the Securities and Exchange Commission (SEC), UnitedHealth discovered a “suspected nation-state associated cyber security threat actor” had access to subsidiary Change Healthcare’s systems on Wednesday. <Read More> From Billionaire Mark Cuban to Independent Store Owners, Criticism for Pharmacy Benefit Managers is Plentiful – February 25, 2024 – At first glance, billionaire entrepreneur Mark Cuban may seem to have little in common with an independent pharmacy owner. But they have one shared adversary: pharmacy benefit managers. They claim the drug price negotiators are putting mom-and-pop drugstores out of business. Pharmacy benefit managers — known as PBMs — are third-­party intermediaries between drug manufacturers and insurance providers. PBMs reimburse pharmacies for the prescriptions customers buy with insurance, but independent pharmacy owners accuse them of reimbursing far less than the actual cost of medications. <Read More> AI May Not Be So Smart When Payors Use It To Deny Medical Claims – February 23, 2024 – Concerns are growing about the increasing use of artificial intelligence to review—and in many cases deny—healthcare claims, sparking a congressional inquiry and lawsuits. Thirty-two legislators sent a letter to the Centers for Medicare & Medicaid Services (CMS) on Nov. 3, 2023, urging increased oversight of the use of these tools in Medicare Advantage (MA) plans. “In recent years, problems posed by prior authorization [PA] have been exacerbated by MA plans’ increasing use of AI or algorithmic software to assist in their coverage determinations in certain care settings, including inpatient hospital, skilled nursing facilities and home health,” wrote the representatives, led by Judy Chu (D-Calif.) and Jerrold Nadler (D-N.Y.). <Read More> Taking Pharmacogenomics Guidelines to Heart – February 23, 2024 – Pharmacogenomics is a rapidly expanding field with new evidence and implications for cardiology practice, experts said during the ASHP 2023 Midyear Clinical Meeting & Exhibition, in Anaheim, Calif. Pharmacogenomics (also known as pharmacogenetics) explores how a person’s genes metabolize medications. The Clinical Pharmacogenetics Implementation Consortium (CPIC) has compiled information about nearly 200 drug–gene associations, many in common cardiology drug classes such as antiarrhythmics, antiplatelet/anticoagulants, beta-blockers and statins, said Jordan Baye, PharmD, MA, BCPS, an assistant professor of pharmacy practice at South Dakota State University, in Brookings. <Read More> FDA Revises EUA for Paxlovid™ – February 21, 2024 – The FDA announced a revision to the emergency use authorization (EUA) for nirmatrelvir+ritonavir (Paxlovid™, Pfizer): Nirmatrelvir+ritonavir manufactured and labeled in accordance with the EUA currently in U.S. distribution will remain authorized for use through the labeled or extended expiration date, as applicable, or through March 8, 2024, whichever is earlier. EUA-labeled nirmatrelvir+ritonavir will no longer be authorized for emergency use after March 8, regardless of the labeled or extended expiration date. However, the nirmatrelvir+ritonavir EUA will continue to authorize emergency use of nirmatrelvir+ritonavir manufactured and labeled in accordance with the new drug application (NDA-labeled nirmatrelvir+ritonavir) for the treatment of mild to moderate COVID-19 in pediatric patients (>12 years of age weighing >40 kg) who are at high risk for progression to severe COVID-19, including hospitalization or death. <Read More> Medication Safety Tools, Pharmacy Technician Usage Up – February 20, 2024 – Health-system pharmacies’ use of technology to improve medication safety and to promote cleanroom compliance has risen, while other metrics such as pharmacist prescribing have remained relatively flat, according to results of the 2023 ASHP National Survey of Hospital Pharmacy Practice. There has been limited change from 2020 to 2023 in pharmacists’ ability to independently prescribe medications pursuant to a diagnosis, said Michael Ganio, PharmD, the senior director of pharmacy practice and quality at ASHP. One of five areas of focus through ASHP’s Practice Advancement Initiative (PAI) 2030—a list of recommendations to advance healthcare and pharmacy practice—was to increase authority for pharmacists to independently prescribe medications by 20% by 2024, he noted during a session at the ASHP 2023 Midyear Clinical Meeting & Exhibition, in Anaheim, Calif. <Read More> Medicare Now Negotiating Price of Drug That Costs $7,100 in US Vs. $900 in Canada – February 6, 2024 – Sen. Bernie Sanders is once again taking the pharmaceutical industry to task, issuing a report Tuesday that highlights the cost of three blockbuster drugs that are far pricier in the US than in other countries. The differences are striking. The annual list price of Bristol Myers Squibb’s Eliquis®, a blood thinner that reduces the risk of stroke, is $7,100 in the US. But in Japan, it’s $940; in Canada, it’s $900; in Germany, it’s $770; in the United Kingdom, it’s $760; and in France, it’s $650. <Read More>

340B in the News

The 340B Hospital Overcharge Controversy: Unveiling the Need for Transparency and Regulation in Healthcare – February 20, 2024 – In a distressing revelation, Adventist Health System, a 340B hospital, has raised serious allegations against some of the world's largest pharmaceutical companies. The hospital claims to have been drastically overcharged by these pharmaceutical giants in a federal drug discount program. This has sparked a wave of concerns about the fairness and transparency of the program and its impact on healthcare providers and patients alike. The allegations revolve around the intricate calculations used to provide medicines to the 340B program. This program necessitates drug manufacturers to offer discounts on all outpatient drugs used by hospitals and clinics primarily serving lower-income patients. In the United States, approximately 12,400 hospitals and clinics participate in this program. These numbers have expanded over the years, making it a substantial market for pharmaceutical companies. <Read More>

Alabama Health System Sues Humana to Recoup MA Payments After 340B Rate Revision – February 13, 2024 - Baptist Health has filed a lawsuit against Humana arguing the payer’s Medicare Advantage plans had underpaid for outpatient drugs purchased through the 340B Drug Pricing Program in light of a 2022 Supreme Court decision that amended rates set by the federal government. In 2018, the Department of Health and Human Services (HHS) cut outpatient drug payments to hospitals participating in the pricing program, which requires drug manufacturers to sell drugs at a discount to safety-net providers, by nearly 30%. The Supreme Court ruled the cut unlawful in 2022, leading HHS to issue a one-time lump sum repayment of about $9 billion to impacted hospitals across the nation. <Read More>