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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 consider final approval of the Biologics License Application (BLA) for AVTOC2, a biosimilar to AbbVie’s Humira (adalimumab). Read More
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. Read More
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 (DOJ) said in a statement. Read More
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 (aripiprazole). Read More
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 over-the-counter ED product in the U.S. Read More
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. Read More
The company’s goal is to offer reduced dose frequency compared to immediate-release carbidopa/levodopa, the gold standard for treatment since the 1970s. Read More
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 arterial hypertension — abnormally high blood pressure in the arteries of the lungs. Read More
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 the California Stem Cell Treatment Center’s (CSCTC) products. Read More