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House members are growing impatient with the FDA over a lack of guidance on biosimilars, with several venting their frustrations during a hearing Thursday. Read More
Generic and biosimilars manufacturers are coming to the aid of Apotex in its drawn-out patent fight with Amgen, arguing that a district court order effectively punishes the Canadian drugmaker for following the law. Read More
Telesta Therapeutics has received a complete response letter from the FDA, informing the company that its BLA for Mycobacterium phlei cell wall-nucleic acid complex would need an additional Phase 3 clinical trial to adequately establish the candidate’s efficacy and safety. Read More
The EMA’s Committee for Medicinal Products for Human Use has recommended six new medicines for marketing authorization, including three innovators and three generics. Read More