The FDA isn’t impressed by the data Amylyx Pharmaceuticals is relying on in its second attempt to get the nod for AMX0035, its investigational amyotrophic lateral sclerosis (ALS) therapy. Source:…
Puerto Rico-based drug manufacturer Skyless was slapped with a five-observation 483 from the FDA that centered on the plant’s lack of any manufacturing procedures and training for employees. Source: Drug…
The FDA has informed Icelandic biosimilars developer Alvotech that it must address issues found in the March 2022 preapproval inspection of the company’s Reykjavik manufacturing facility before the agency will…
Bayer has agreed to pay $40 million to resolve alleged violations of the False Claims Act (FCA) in connection with three of the company’s drugs, the U.S. Department of Justice…
Otsuka Holdings and H. Lundbeck filed another lawsuit in an attempt to stop Viatris (formerly Mylan) from marketing a generic of the injectable version of the antipsychotic drug Abilify Maintena…
Futura Medical’s MED3000, a drug-free topical gel for treating erectile dysfunction (ED), stood up well against Cialis (tadalafil) in a phase 3 study that could ultimately lead to the first…
During an inspection of BPI Labs in Evanston, Wyo., the FDA’s investigator found multiple issues with production and quality control records, as well as areas of potential product contamination. Source:…
A U.S. District Court in Delaware has decided in favor of United Therapeutics over Liquidia in one of its patent disputes over Tyvaso (treprostinil), a drug used to treat pulmonary…
A federal judge ruled earlier this week that stem cell therapies are procedures, not drugs, and that the FDA has no jurisdiction over them, blocking the agency’s attempt to regulate…
Novo Nordisk is beefing up its hematologic portfolio with the $1.1 billion acquisition of Forma Therapeutics, snagging the company’s late-stage sickle cell anemia candidate etavopivat. Source: Drug Industry Daily