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Sanofi has failed to convince a federal appeals court that Viatris monopolized the market for injected epinephrine through anticompetitive pricing for its EpiPen. Read More
Swiss biotech ObsEva has announced a corporate restructuring and layoffs following a notice from the FDA that the company’s new drug application (NDA) for its lead candidate linzagolix for uterine fibroids has deficiencies that are keeping the agency from advancing its review. Read More
This second part of Drug Industry Daily’s two-part report on user fee reauthorization focuses on prospects for the Biosimilar User Fee Act and the Generic Drug User Fee Act.Read More
The agency said all changes to disposable manufacturing materials for approved drug products should be communicated to the FDA through postapproval submissions. Read More
Recognizing that a lack of standard methods is the primary challenge to widespread manufacturing of cell and gene therapies, two groups are aiming to lower the barrier by bringing best practices to this branch of the life sciences industry. Read More
This two-part series hones in on the specifics of the House and Senate user fee bills, their differences and what the final law, the Food and Drug Administration Safety and Landmark Advancements (FDASLA), may look like when it gets to President Biden’s desk.Read More
The FDA issued a warning letter to Jost Chemical Co. — an active pharmaceutical ingredient (API) manufacturer based in Saint Louis, Mo. — for what the agency said was an inadequate investigation into a quality-related complaint and out-of-specification results. Read More
Armed with a re-analysis of a previously negative trial and some FDA encouragement, German biotech InflaRx intends to seek Emergency Use Authorization (EUA) for its first-in-class anti-C5a monoclonal antibody vilobelimab for critically ill, ventilated COVID-19 patients. Read More