New Drug/Vaccine Approval

Rytelo™ (imetelstat) for Injection - New Drug Approval – June 6, 2024 – Geron Corporation (Nasdaq: GERN), a commercial-stage biopharmaceutical company aiming to change lives by changing the course of blood cancer, announced that the U.S. Food and Drug Administration (FDA) has approved Rytelo™ (imetelstat) for the treatment of adult patients with low- to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent (TD) anemia requiring four or more red blood cell units over eight weeks who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESA). <Read More>  mRESVIA® (respiratory syncytial virus vaccine, mRNA) Injection – New Vaccine Approval – May 31, 2024 – Moderna, Inc. (NASDAQ:MRNA) announced that the U.S. Food and Drug Administration (FDA) has approved mRESVIA® (mRNA-1345), an mRNA respiratory syncytial virus (RSV) vaccine, to protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection. The approval was granted under a breakthrough therapy designation and marks the second approved mRNA product from Moderna. <Read More> Onyda™ XR (clonidine hydrochloride) Extended-Release Suspension – New Drug Approval – May 24, 2024 – Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company focused on attention deficit hyperactivity disorder (ADHD), pain, addiction and neurological disorders, announced the U.S. Food and Drug Administration (FDA) has approved Onyda™ XR (clonidine hydrochloride), a once-a-day extended-release oral suspension with nighttime dosing, for the treatment of ADHD as a monotherapy or as an adjunctive therapy to approved central nervous system (CNS) stimulant medications in pediatric patients six years and older. <Read More> Imdelltra™ (tarlatamab-dlle) for Injection – New Drug Approval – May 16, 2024 – The Food and Drug Administration granted accelerated approval to tarlatamab-dlle (Imdelltraä, Amgen, Inc.) for extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. Efficacy was evaluated in 99 patients with relapsed/refractory ES-SCLC with disease progression following platinum-based chemotherapy enrolled in DeLLphi-301 [NCT05060016], an open-label, multicenter, multi-cohort study. Patients with symptomatic brain metastases, interstitial lung disease or non-infectious pneumonitis, and active immunodeficiency were excluded. Patients received tarlatamab until disease progression or unacceptable toxicity. <Read More>

New Indication/Dosage/Formulation Approval

Arexvy® (respiratory syncytial virus vaccine, adjuvanted) Suspension for Intramuscular Injection – New Label Expansion – June 7, 2024 – GSK plc (LSE/NYSE: GSK) announced that the US Food and Drug Administration (FDA) has approved Arexvy® (Respiratory Syncytial Virus (RSV) Vaccine, Adjuvanted) for the prevention of RSV lower respiratory tract disease (LRTD) in adults 50 through 59 years of age who are at increased risk. In the US, the vaccine is currently approved for use in adults aged 60 and older and recommended by CDC/ACIP using shared clinical decision-making. <Read More> Breyanzi® (lisocabtagene maraleucel) Suspension for Intravenous Infusion – New Label Expansion – May 30, 2024 – Bristol Myers Squibb (NYSE: BMY) announced the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Breyanzi® (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of systemic therapy. This indication is approved under accelerated approval based on response rate and duration of response. <Read More> Retevmo® (selpercatinib) Capsules and Tablets – New Label Expansion – May 29, 2024 – The Food and Drug Administration granted accelerated approval to selpercatinib (Retevmo® , Eli Lilly and Company) for pediatric patients two years of age and older with the following:  1) Advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy; 2) Advanced or metastatic thyroid cancer with a RET gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate); and 3) Locally advanced or metastatic solid tumors with a RET gene fusion, as detected by an FDA-approved test, that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options. <Read More> Benlysta® (belimumab) Injection – New Label Expansion – May 16, 2024 – GSK plc (LSE/NYSE: GSK) announced that the US Food and Drug Administration (FDA) has approved a 200 mg subcutaneous route of administration of Benlysta® (belimumab), a B-lymphocyte stimulator (BLyS)-specific inhibiting monoclonal antibody, for patients five years of age and older with active systemic lupus erythematosus (SLE) who are receiving standard therapy. This option provides pediatric patients the possibility to receive the treatment at home. <Read More> Breyanzi® (lisocabtagene maraleucel) Suspension for Intravenous Infusion – New Label Expansion – May 15, 2024 – Bristol Myers Squibb (NYSE: BMY) announced the U.S. Food and Drug Administration (FDA) has granted approval for Breyanzi® (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least two prior lines of systemic therapy, including a Bruton tyrosine kinase (BTK) inhibitor. This FDA approval marks the fourth distinct subtype of non-Hodgkin lymphoma for which Breyanzi is approved, making it the CAR T cell therapy available to treat the broadest array of B-cell malignancies. <Read More>

New Drug Shortage

June 10, 2024

• Vitamin A Palmitate Injection (Currently in Shortage)

June 04, 2024 

• Calcium Chloride; Dextrose; Magnesium Chloride; Sodium Chloride; Sodium Lactate Solution (Discontinuation)

• Estradiol Valerate Injection (Discontinuation)

May 30, 2024

• Furosemide Injection (Currently in Shortage)

May 24, 2024

• Insulin Glargine Injection (Discontinuation)

May 17, 2024

• Azithromycin for Suspension (Discontinuation)

Updated Drug Shortage

June 06, 2024

• Sodium Acetate Injection (Currently in Shortage)

May 05, 2024

• Atropine Sulfate Injection (Currently in Shortage)

• Azacitidine Injection (Currently in Shortage)

• Bumetanide Injection (Currently in Shortage)

• Bupivacaine Hydrochloride Injection (Currently in Shortage)

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

• Carboplatin Injection (Currently in Shortage)

• Cefotetan Disodium Injection (Currently in Shortage)

• Chloroprocaine Hydrochloride Injection (Currently in Shortage)

• Cisplatin Injection (Currently in Shortage)

• Cytarabine Injection (Currently in Shortage)

• Dacarbazine Injection (Currently in Shortage)

• Dexamethasone Sodium Phosphate Injection (Currently in Shortage)

• Dexmedetomidine Hydrochloride Injection (Currently in Shortage)

• Dextrose Monohydrate Injection (Currently in Shortage)

• Epinephrine Bitartrate, Lidocaine Hydrochloride 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)

• Hydromorphone Hydrochloride Injection (Currently in Shortage)

• Ketorolac Tromethamine Injection (Currently in Shortage)

• Leucovorin Calcium Injection (Currently in Shortage)

• Lidocaine Hydrochloride Injection (Currently in Shortage)

• Methotrexate Sodium Injection (Currently in Shortage)

• Midazolam Hydrochloride Injection (Currently in Shortage)

• Morphine Sulfate Injection (Currently in Shortage)

• Remifentanil Hydrochloride Injection (Currently in Shortage)

• Rifampin Injection (Currently in Shortage)

• Rocuronium Bromide Injection (Currently in Shortage)

• Ropivacaine Hydrochloride 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)

• Sterile Water Injection (Currently in Shortage)

• Valproate Sodium Injection (Currently in Shortage)

• Vinblastine Sulfate Injection (Currently in Shortage)

June 04, 2024

• Disopyramide Phosphate Capsule (Resolved)

• Dulaglutide Injection (Currently in Shortage)

• Liraglutide Injection (Currently in Shortage)

• Somatropin Injection (Currently in Shortage)

• Tirzepatide Injection (Currently in Shortage)

May 31, 2024

• Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate

• Dexmedetomidine Hydrochloride Injection (Currently in Shortage)

• Fentanyl Citrate Injection (Currently in Shortage)

• Flurazepam Hydrochloride Capsule (Currently in Shortage)

• Hydromorphone Hydrochloride Injection (Currently in Shortage)

• Morphine Sulfate Injection (Currently in Shortage)

• Sufentanil Citrate Injection (Currently in Shortage)

May 30, 2024

• Alprostadil Suppository (Currently in Shortage)

• Dexmedetomidine Hydrochloride Injection (Currently in Shortage)

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

• Remifentanil Hydrochloride Injection (Currently in Shortage)

• Vecuronium Bromide Injection (Currently in Shortage)

New Drug Recall and Safety Alerts

Sagent Pharmaceuticals Issues Voluntary Nationwide Recall of Docetaxel Injection, USP – New Voluntary Recall – May 28, 2024 – Sagent Pharmaceuticals announced the voluntary nationwide recall of two lots of Docetaxel Injection, USP (80 mg per 8 mL multi-dose vials and 160 mg per 16 mL multi-dose vials). The product was distributed by Sagent Pharmaceuticals. Sagent has initiated this voluntary recall of Docetaxel Injection, USP to the User Level as the result of a customer complaint due to potential presence of particulate matter from the stopper in the drug product. <Read More> Buprenorphine Hydrochloride Injection Carpuject™ Units and Labetalol Hydrochloride Injection, USP Carpuject™ Units Hospira Inc. - New Voluntary Recall – May 22, 2024 - Hospira, Inc., a Pfizer company (“Pfizer”), is voluntarily recalling the lots listed in the table below of Buprenorphine Hydrochloride Injection Carpuject™ Units and Labetalol Hydrochloride Injection, USP Carpuject™ Units to the User level. The recall was initiated due to the potential for incomplete crimp seals; one customer complaint has been received for one leaking unit. <Read More>

New Generic/Biosimilar Approval and Launch

Bkemv™ (eculizumab-aeeb) Injection – New Biosimilar Approval – May 28, 2024 – The U.S. Food and Drug Administration approved Bkemv™ (eculizumab-aeeb) as the first interchangeable biosimilar to Soliris (eculizumab) to treat certain rare diseases. Bkemv™ is approved for the following treatment indications, which are also currently approved for Soliris:  1) the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis; and 2) the treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy. <Read More> Opuviz™ (aflibercept-yszy) and Yesafiliä (aflibercept-jbvf) Injection – New Biosimilar Approvals – May 20, 2024 – FDA approved Yesafili™ (aflibercept-jbvf) and Opuviz™ (aflibercept-yszy) as interchangeable biosimilars to Eylea® (aflibercept). Aflibercept products work by inhibiting vascular endothelial growth factor (VEGF) which prevents abnormal blood vessel growth within the eye. By blocking VEGF, aflibercept products can slow down or reduce damage to the retina and help preserve vision. <Read More>

Clinical and Pharmacy News

Clinical Practice Guideline Updated for Service Members and Veterans at Risk for Suicide – June 6, 2024 – For adults who served or current active duty military at high risk of suicidal thoughts or actions, new guidance for clinicians can streamline the help they need. Updated clinical practice guidelines, otherwise known as CPGs, from the Department of Defense and the Department of Veterans Affairs are an essential tool in assessing and managing patients and offer evidence-based recommendations for health care providers, according to Isabella Alvarez, nurse administrator coordinator, DOD program management for VA-DOD clinical practice guidelines. A joint VA-DOD working group announced in May 2024 the release of the revised guideline, “The Assessment and Management of Patients at Risk for Suicide (2024),” to aid in critical decision points, Alvarez said. <Read More> How a St. Paul Pharmacy's Fight for Survival is Tied to the 'Middle Men' of Drug Pricing – June 7, 2024 –Lavonne Meyer is no stranger to the St. Paul Corner Drug Store…“We can't continue to do business with PBMs that aren't going to pay us the cost to do business,” said Hoeschen. Hoeschen is talking about the reimbursements that PBMs pay to pharmacies for dispensing specific drugs. When he took over ownership of the pharmacy in the 1990s, those reimbursements were enough to pay the pharmacy's bills and keep its doors open. However, those reimbursements from PBMs have continued to drop, and according to Hoeschen, the drop has been so severe that the pharmacy is now losing money on most of the prescriptions it fills for patients, which, in turn, led the pharmacy to stop taking new patients. <Read More> U.S. Pharmacy Benefit Management Market Size to Reach USD 853.50 Bn by 2033 – June 3, 2024 – According to latest study, the U.S. pharmacy benefit management market size is calculated at USD 518.24 billion for 2024 and is expected to reach around USD 853.50 billion by 2033, growing at a CAGR of 5.7% from 2024 to 2033. Pharmacy Benefit Managers (PBMs) play a crucial role in the U.S. healthcare system, facilitating safe, efficient, and affordable access to prescription drugs for over 260 million Americans. <Read More> Pharmacy Benefit Coverage of CGMs Increases Uptake – May 30, 2024 – Covering continuous glucose monitors (CGMs) through a pharmacy, versus medical, benefit resulted in improvements in hemoglobin A1c and average glucose scores in people with diabetes, according to data presented in a bronze award–winning poster (E6) at AMCP 2024, in New Orleans. “The importance [of this study] for employers and health plans [is] to identify and address barriers such as prior authorizations and copays that are limiting a person’s access to a proven technology, such as CGM, that can help a person manage diabetes effectively,” said study author Roy Thomas, PharmD, the director of managed markets medical affairs at Dexcom, in San Diego. “As employers and health plans improve access to CGM, pharmacists and prescribers can confidently recommend and prescribe it to their patients with diabetes regardless of their treatment, without concerns of insurance not covering the CGM.” <Read More> Focus on Women’s Health, From Contraception to Well-Being – May 29, 2024 – May is Women’s Health Awareness Month and the perfect time to highlight the vital role pharmacists play in medication therapy management (MTM). From reproductive health to osteoporosis prevention, pharmacists can provide a variety of services to support women’s health initiatives such as health screening, maternal vaccinations, and reproductive health services. One of the goals of Healthy People 2030 focuses on women’s health, including topics such as cancer, family planning, foodborne illness, osteoporosis, pregnancy and childbirth, sexually transmitted infections, tobacco use, and vaccinations. <Read More>

340B in the News

Lawsuits Pile up Over State Laws on Discounts for Hospitals' Contract Pharmacies – June 3, 2024 – The pharmaceutical industry has filed at least four lawsuits this year challenging state laws requiring drugmakers to offer discounts on drugs dispensed by third-party pharmacies that contract with hospitals and clinics serving low-income populations… All of the lawsuits say that the state laws conflict with the federal law governing a drug-discount program for hospitals and clinics that serve low-income populations, known as 340B. Drugmakers must participate in the 340B program in order to receive funds from government health insurance programs like Medicare and Medicaid. <Read More> An Obscure Drug Discount Program Stifles Use of Federal Lifeline by Rural Hospitals – May 30, 2024 – Facing ongoing concerns about rural hospital closures, Capitol Hill lawmakers have introduced a spate of proposals to fix a federal program created to keep lifesaving services in small towns nationwide. In Anamosa, Iowa — a town of fewer than 6,000 residents located more than 900 miles from the nation’s capital — rural hospital leader Eric Briesemeister is watching for Congress’ next move. The 22-bed hospital Briesemeister runs averages about seven inpatients each night, and its most recent federal filings show it earned just $95,445 in annual net income from serving patients. Yet Briesemeister isn’t interested in converting the facility into a rural emergency hospital, which would mean getting millions of extra dollars each year from federal payments. In exchange for that financial support, hospitals that join the program keep their emergency departments open and give up inpatient beds. <Read More> Manufacturers Are “Winning” in the 340B Drug Discount Dispute – May 29, 2024 – Section 340B of the Public Health Service Act has grown significantly since its enactment in 1992 – both in the number of covered entities eligible to participate and in the volume of drugs purchased through the program. The rapid growth in the discount drug program has caused a series of legal challenges between manufacturers and providers. Manufacturers secured an important victory on May 21, 2024, when the U.S. Court of Appeals for the District of Columbia Circuit upheld the U.S. District Court for the District of Columbia’s decision in United Therapeutics Corporation v. Carole Johnson, et al./Novartis Pharmaceuticals v. Carole Johnson (consolidated cases). The D.C. Circuit affirmed that Section 340B does not categorically prohibit manufacturers from imposing conditions on the distribution of covered drugs to covered entities. This is the second federal appeals court to rule on the ongoing 340B drug discount dispute. <Read More> Talks to Expand 340B Medicaid Drug Program to Continue Next Session – May 28, 2024 – New York lawmakers do not expect to reach an agreement to expand the state's managed Medicaid prescription drug reimbursement program, known as 340B, before session ends in the next two weeks — saying Tuesday the debate will continue next year amid a push for greater oversight to ensure hospitals give adequate aid to distressed health centers…The state transitioned last year to a system to directly manage pharmacy reimbursements in attempts to rein in Medicaid spending that continues to grow at an unsustainable rate and give greater transparency into prescription drug costs. Impacted health providers say the change has led to a decrease in savings for clinics other providers that serve low-income patients. <Read More>