Approval of Cosette’s first US generic to Rectiv came with a six-month exclusivity as the originator drug had “inadequate generic competition,” but the company has 75 days to enter the market.
The US Food and Drug Administration has given the green light to Cosette Pharmaceuticals to launch the first generic version of originator AbbVie’s Rectiv (nitroglycerin) ointment, 0.4%.
The agency approved Cosette’s abbreviated new drug application with 180 days of competitive generic therapy exclusivity. The company said it...
Celltrion has reinforced its commitment to the UK by opening a new central operations hub in Uxbridge, while acknowledging that “major questions over the attractiveness of the market” need to be addressed to encourage development and ensure a sustainable environment for UK biosimilars.
England’s Court of Appeal has upheld a Competition Appeal Tribunal’s 2023 finding that Advanz and its former owner Cinven abused their dominant position in the UK market for liothyronine tablets by charging prices that were many orders of magnitude higher than the benchmark for fair pricing.
Tevogen is looking to accelerate its growth with a major expansion of its headquarters in Warren, New Jersey, more than doubling its footprint to centralize research and development, regulatory, and corporate functions. The new facility will support the company’s evolving initiatives.
