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The FDA’s latest biosimilar user fee negotiations with industry representatives focused on the agency’s proposals for a regulatory science pilot program and guidance on biosimilar interchangeability, as well as furthering discussions on several other topics. Read More
President Biden’s request for an additional $343 million in FDA budget authority for fiscal 2022 has been met with enthusiasm by the Alliance for a Stronger FDA, which lauds the proposed boost in agency funds but cautions that Congress could become entangled in debates about caps for overall federal funding this year. Read More
Bristol Myers Squibb (BMS) has been sued for $6.4 billion by former Celgene shareholders for allegedly delaying FDA approval of its cancer drug Breyanzi (lisocabtagene maraleuce). Read More
Emergent BioSolutions was hit with a potential class-action lawsuit on Wednesday, alleging the company made false and misleading statements regarding its manufacturing capabilities and quality control processes at its Bayview facility in Baltimore, Md. Read More
Scynexis has secured FDA approval for Brexafemme (ibrexafungerp) as an oral treatment for vaginal yeast infections, making it the first FDA-approved drug in a novel antifungal class in more than 20 years, according to the company. Read More
Verily has enlisted Amy Abernethy, the FDA’s former principal deputy commissioner and acting chief information officer, as its next president of clinical research. Read More
A controversial bankruptcy settlement is moving forward in the sprawling opioid litigation against Purdue Pharma despite fierce resistance from dozens of attorneys general. Read More
With a Drug Supply Chain Security Act (DSCSA) implementation date set for 2023, the FDA has published four guidances designed to bolster efforts to identify and trace drugs as they move through the supply chain, including a final guidance clarifying product identifier requirements for drugmakers. Read More
Moderna has struck a fill-and-finish deal with Thermo Fisher Scientific to produce hundreds of millions of doses of Moderna’s messenger RNA-based COVID-19 vaccine at its Greenville, N.C., plant. Read More