Bristol Myers Squibb (BMS) and three US subsidiaries of Paris-based Sanofi owe the state of Hawaii a combined $916 million over safety disclosure failures with blood-thinning drug Plavix, following a…
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…
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.…
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…
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…
Magellan Diagnostics has agreed to plead guilty and pay $42 million for concealing a device malfunction for years that produced inaccurately low lead test results for potentially tens of thousands…
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…
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…
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…
This edition of Quick Notes features announcements of Takeda, Abbvie and Novo Nordisk drug development collaborations and J&J’s acquisition of Proteologix. Source: Drug Industry Daily