Sandoz announced a $275m settlement to resolve class action antitrust litigation over price-fixing allegations and disclosed that the company made a further provision of $265m linked to the case.
Sandoz has agreed to pay another $275m to settle litigation related to historical price-fixing allegations in the US with end payer plaintiffs in a class-action lawsuit.
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Three weeks after its user fee goal date, the FDA demanded a postmarketing commitment “to generate additional data,” Novavax said.
No mass exodus was seen from stand-alone prescription drug plans to Medicare Advantage drug plans between 2024 and 2025, according to one actuary.
PhRMA questioned whether proof-of-concept studies are needed before an INTERACT meeting and said a draft guidance describing the timing of definitive toxicology studies creates confusion.
Sanofi's Paul Hudson and Novartis's Vas Narasimhan claim that while Europe is home to some of the most important biopharma companies in the world, its position is in jeopardy.
The Health and Human Services Department's decision to eliminate the Richardson Waiver may be a blow for transparency, but will not completely eliminate scrutiny of regulations, experts said.
President Trump’s CDC director nominee was pulled after vaccine positions appeared too extreme for some Republicans, but the nominations to lead the FDA and NIH advanced to the Senate floor despite last-minute drama.
Health and Human Services Secretary Robert F. Kennedy Jr. is moving FDA Chief Counsel Robert Foster to a new senior position as Chief Counsel for Food, Research, and Drugs at HHS. Hilary Perkins will become FDA chief counsel.
