ORLANDO, Fla. – In an effort to get sickle cell disease (SCD) researchers, drug developers, patients and regulators all on the same page, the American Society of Hematology (ASH) and the FDA have released new recommendations aimed at establishing uniform global standards for clinical trial endpoints to evaluate new therapies.
An FDA review of Enzyvant Inc.'s RVT-802, a tissue-based therapy for children born without a thymus, has drawn a complete response letter (CRL) from the agency over concerns about chemistry, manufacturing and controls, scuttling hopes it would become the first FDA-designated regenerative medicine advanced therapy (RMAT) to win approval from the agency.
The U.S. FDA has granted investigational device exemption approval for the use of Personal Genome Diagnostics Inc.’s (PGDx) elio tissue complete assay in a Merck & Co. Inc. trial of a Keytruda (pembrolizumab)-based combination therapy.
BEIJING – China has updated its national reimbursement drug list (NRDL) to include innovative drugs that it has recently approved, including homegrown cancer drugs and foreign imports. Industry experts said they believe it is a move to drive biotech innovation at home.
HONG KONG – Celltrion Healthcare Co. Ltd., a South Korean biopharmaceutical corporation, won European Union (EU) marketing approval for Remsima SC for the treatment of rheumatoid arthritis (RA), as a subcutaneous version of Celltrion’s infliximab biosimilar, CT-P13.
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