DUBLIN – Merck & Co. Inc. is in line to obtain conditional marketing authorization from the European Union for its live attenuated vaccine for preventing Ebola virus infection, V920 Ebola Zaire vaccine (rVSVDG-ZEBOV-GP live), following a positive recommendation for approval from the EMA's Committee for Human Medicinal Products (CHMP) at its October meeting last week. Formal approval should follow within 67 days, after which the Kenilworth, N.J.-based pharma would market the vaccine as Ervebo.
Regulatory decisions affecting biopharma products in development, including approvals, recommendations, rejections and the granting of regulatory pathways, in September 2019.
WASHINGTON – The U.S. FDA's 2018 final guidance for payer communications widely was seen as long overdue upon delivery. For his part, Paul Savidge, U.S. general counsel at Philadelphia-based Spark Therapeutics Inc., said his company's development of the required information for such communication was "a massive undertaking" that proved useful a second time when it came to promoting its product after FDA approval.
The FDA continues to break records in approving generics to ramp up competition in the U.S. drug market. In fiscal 2019, the agency approved 1,171 generic drug approvals – 935 full approvals and 236 tentative approvals. That breaks fiscal 2018's record of 971 approvals, Acting FDA Commissioner Ned Sharpless said. The 2019 approvals included 125 applications for first generics of drugs that had no generic competition.
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