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According to the FDA, the selected START participants will be able to obtain frequent advice and regular ad-hoc communication with agency staff. Read More
A New Jersey federal judge has ordered Teva Pharmaceuticals to remove from the Orange Book five patents on its ProAir HFA asthma inhalation device, clearing the way for Amneal Pharmaceuticals to launch a generic version. Read More
The FDA’s 11-person Peripheral and Central Nervous System Drugs Advisory Committee unanimously endorsed both the efficacy and safety of Lilly’s antiamyloid antibody donanemab, saying that people with Alzheimer’s disease and their clinicians should be the ones to decide whether the drug’s modest cognitive benefit outweighs its risk of serious adverse events. Read More
The FDA sent an untitled letter to Achieve Vitality, which markets a product claiming to offer regenerative therapy, for offering an injectable product derived from human umbilical cord for which the company lacks required regulatory approvals. Read More
The FDA has selected seven rare disease therapies to participate in its Support for clinical Trials Advancing Rare disease Therapeutics (START) Pilot Program to accelerate the development of novel drug products through, in part, enhanced communications with the agency. Read More
CDER, as part of its Emerging Drug Safety Technology Program (EDSTP) will hold meetings for drug makers and others to discuss their research, development, and use of AI and other emerging technologies in pharmacovigilance. Read More
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
CDER plans to refuse to approve a supplemental new drug application (sNDA) for Vanda Pharmaceuticals’ Hetlioz (tasimelteon), in the latest of a back and forth battle over the drug dating back to 2018. Read More
Generic sterile injectables — such as antibiotics, anesthetics and vaccinations — faced a 91 percent risk of being in short supply in 2023 and 58 percent of injectable drugs went into shortage in 2023, according to a report by the United States Pharmacopeia (USP). Read More