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Eli Lilly will make a case for its antiamyloid antibody donanemab on June 10, trying to reassure the Peripheral and Central Nervous System Advisory Committee that the drug is safe, despite the serious adverse events related to the deaths of five people during the drug’s pivotal phase 3 trial. Read More
Drug-induced liver disease observed in a phase 1/2 clinical trial of Biomea Fusion’s BMF-219 (covalent menin inhibitor) in type 1 and type 2 diabetes has resulted in the FDA requesting a full clinical hold. Read More
The FDA is not required to follow the recommendations of the committee, and had expressed its own doubts about the drug in its briefing documents. Read More
Members of the FDA’s Psychopharmacological Drugs Advisory Committee voted strongly against recommending MDMA, also known as “ecstasy,” as a potential treatment for post-traumatic stress disorder (PTSD) at their meeting on Tuesday. Read More
How can regulators judge the efficacy and safety of a product that makes patients feel so good, so quickly, that trial blinding is impossible, and the drug’s positive effects may carry abuse potential? Read More
This edition of Quick Notes focuses on FDA drug approvals for relapsed or refractory lymphoma, a nighttime non stimulant liquid ADHD treatment for children, extensive-stage non-small cell lung cancer and an mRNA vaccine for RSV. Read More
Bkemv, like Soliris, has a boxed warning that states that eculizumab products increase the risk of serious and life-threatening meningococcal infections. Read More
Sanofi and development partner Regeneron are riding a regulatory roller coaster, with the EU giving Dupixent (duplilumab) a nod for chronic obstructive pulmonary disease (COPD) even as the FDA hedges, asking for more phase 3 data before granting the new indication. Read More
The FDA approved Amgen’s Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to AstraZeneca’s Soliris (eculizumab) to treat the rare diseases paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). Read More
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee will attempt to balance the benefits of Novo Nordisk’s once-weekly insulin injection Awiqli with an increased risk of moderate and severe hypoglycemia at its May 24 meeting. Read More