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Notification requirements under the federal biosimilars law are getting renewed attention with two recent court filings: one, a petition to the U.S. Supreme Court, and the other an amicus brief before the U.S. Court of Appeals for the Federal Circuit. Read More
An NHS England spokesperson has confirmed that the agency will investigate whether more than 130 NHS staff involved in assessing drugs were also paid as consultants by drugmakers. Read More
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