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Sens. Joe Manchin (D-W.Va) and Edward Markey (D-Mass.) will maintain their holds on the nomination of Robert Califf for the top job at the FDA, despite the agency’s announcement Thursday that it would overhaul its opioid policies. Read More
FDA reviewers have given their support to Celltrion’s proposed biosimilar for Remicade, finding no clinically meaningful differences between the copy and the original. 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
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