The latest global regulatory news, changes and updates affecting biopharma, including: Medicines and Healthcare Products Regulatory Agency, Moderna, Office of the U.S. Trade Representative, Pan American Health Organization, SEC, Therapeutic Goods Administration, World Health Organization.
News from Biogen Inc. and partner Eisai Co. Ltd. that U.S. regulators accepted the BLA related to aducanumab for Alzheimer’s disease (AD) – and assigned it priority review, no less – set Wall Street abuzz.
PERTH, Australia – Patients with relapsed or refractory acute myeloid leukemia (r/r AML) who have received three or more lines of therapy are often too sick to get much-needed bone marrow transplants and often run out of options.
HONG KONG – Following positive phase II data on Hanmi Pharmaceutical Co. Ltd.’s once-weekly GLP-1/glucagon receptor dual agonist, efinopegdutide, in nonalcoholic steatohepatitis (NASH), the Seoul-based company has exclusively licensed the drug to Kenilworth, N.J.-based Merck & Co. Inc. for the indication.
HONG KONG – Tel Aviv-based Teva Pharmaceutical Industries Ltd. has inked an exclusive strategic agreement with Reykjavik, Iceland-based Alvotech hf to commercialize five biosimilar product candidates in the U.S.
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