Latest From Catalent Inc.
Mega-merger's top US drug candidates are seeking space in crowded fields. That means they have to get through the FDA fast, and priority review vouchers figure prominently in both improving and lowering the odds.
An FDA warning letter issued to Aurobindo highlights recurring failures over several sites, while Teva is setting up a biologics development campus in the US and Nexus is investing in sterile injectables capacity.
Currently focused on HBV, Altimmune gets preclinical NASH candidate that offers dual agonism of GLP-1 and glucagon receptors. Nimbus expands alliance with Celgene into IO, Merck & Co. partners with Skyhawk.
Partnership will use Carna’s proprietary lipid kinase drug discovery platform, bringing another aspect to Gilead’s IO efforts. Catalent continues expansion by acquiring Novavax R&D assets; Genfit licenses elafibranor in China to Terns.
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