New Drug/Vaccine Approval

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

New Indication/Dosage/Formulation Approval

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

New Drug Shortage

August 08, 2024

• Bromocriptine Mesylate Tablet (Discontinuation)

August 07, 2024

• Memantine Hydrochloride Capsule, Extended Release (Discontinuation)

Updated Drug Shortage

August 06, 2024

• Carboplatin Injection (Currently in Shortage)

• Semaglutide Injection (Currently in Shortage)

August 05, 2024

• Bupivacaine Hydrochloride Injection (Currently in Shortage)

• Dexamethasone Sodium Phosphate Injection (Currently in Shortage)

• Lidocaine Hydrochloride Injection (Currently in Shortage)

• Methylprednisolone Acetate Injection (Currently in Shortage)

• Rocuronium Bromide Injection (Currently in Shortage)

• Ropivacaine Hydrochloride Injection (Currently in Shortage)

New Drug Recall and Safety Alerts

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

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

New Generic/Biosimilar Approval and Launch

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

Clinical and Pharmacy News

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

340B in the News

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