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In the latest of a string of manufacturing snafus plaguing Indian drugmakers, the French National Agency for Medicines and Health Products Safety is calling for the withdrawal of Anuh Pharma’s GMP certificate. Read More
Janssen has moved to a continuous manufacturing process at one of its facilities after getting the green light April 8 from the FDA to switch from batch production, making it the first drugmaker allowed to change its production method mid-cycle. Read More
An FDA advisory committee recommended three drug substances for inclusion to a list of approved compounding substances and shot down three others. Read More
Teva Pharmaceuticals and AstraZeneca have settled patent litigation with a licensing agreement that enables Teva to market and manufacture a generic version of AstraZeneca’s diabetes drug Byetta. Read More
House Republicans have rolled out a broad proposal to replace the Affordable Care Act that includes several measures to streamline drug development. Read More