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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
Drug shortages, patent tussles, and gripes about the Inflation Reduction Act (IRA) headlined the conversation at an FDA “check-up” meeting conducted by the House Energy and Commerce’s subcommittee on health. Read More
Several senators on both sides of the aisle brought up the many bipartisan bills that have passed the House and Senate committees in recent years. Read More
One of the biggest mistakes companies make in their responses to the FDA’s inspection observations is to focus on the specific issues raised without looking at the bigger picture, according to one regulatory compliance expert. Read More
NIH is seeking comments on a new policy that would require partnering organizations who receive institute funding to submit a plan outlining steps they will take — through a patent licensing agreement — to promote patient access to any resulting drug, biologic, vaccine or device. Read More
Akan Biosciences, the manufacturer of a sterile injectable biologic product, received an FDA Warning Letter for failing to properly test donor tissue samples for communicable diseases and failing to have an approved BLA. Read More
Congress needs to put more pressure on agencies like the FDA and the US Patent and Trademark Office (USPTO) to collaborate on fighting patent thickets, the multiple patents pharmaceutical companies file after a drug is already on the market to extend the drug’s period of exclusivity and keep generic alternatives off the market. Read More
Without strong economic incentives, the current antibiotic development pipeline won’t keep pace with burgeoning rates of antibiotic resistance, according to a new study by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). Read More
This edition of Quick Notes features announcements of Takeda, Abbvie and Novo Nordisk drug development collaborations and J&J’s acquisition of Proteologix. Read More
The FDA has a lot of work to do to regain trust among a wide swath of demographic groups — starting with women — according to a recent survey. Read More