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The European Medicines Agency has accepted Sandoz’s MAA for its biosimilar to Amgen’s Neulesta to help the body make white blood cells after receiving cancer medications. Read More
The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended six medicines for marketing authorization — three new products and three generics. 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 UK’s National Institute for Health and Care Excellence has given a thumbs-down to the cholesterol drug Praluent, but a tentative nod to competitor Repatha. Read More
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