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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
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
The 340B Drug Discount Program needs more regulation, oversight and transparency to combat abuse by bad actors, according to members of the House Energy and Commerce Committee’s Oversight and Investigations Subcommittee. Read More
The FDA has released two draft guidances on how sponsors can prepare for bioresearch monitoring inspections (BIMO) in both their marketing applications as well as prior to and during the BIMO inspections themselves. Read More
Novartis has taken up the legal sword against Maryland and West Virginia over state legislation that would widen the powers of the controversial 340B program. Read More
In responding to an FTC/HHS request for information (RFI) on how drug wholesalers and group purchasing organizations (GPOs) influence generic drug shortages, the trade group for generic and biosimilar drug manufacturers has requested an investigation of the drug buyers’ practices. 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
Bkemv, like Soliris, has a boxed warning that states that eculizumab products increase the risk of serious and life-threatening meningococcal infections. Read More
Novo Nordisk has sued nine more companies for selling products billed as containing semaglutide, a primary ingredient in the Danish pharma’s popular weight loss drug Wegovy. Read More