Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arbor, Ascletis, Bluebird, BMS, Cytodyn, Dcprime, Ferring, Novocure, Rhythm, Sunovion, Zai Lab.
Abbott Laboratories received FDA emergency use authorization (EUA) for its COVID-19 molecular test, which will run on the company's new Alinity m system, as well as its COVID-19 antibody blood test, which will run on the Alinity i system. The two actions bring to five the number of COVID-19 tests developed by the Abbott Park, Ill.-based company to receive EUAs.
HONG KONG – South Korea’s Bridge Biotherapeutics Inc. wrapped up the week by announcing its awaited IND clearance for its epidermal growth factor receptor tyrosine kinase inhibitor, BBT-176, for non-small-cell lung cancer.
BEIJING – Canbridge Pharmaceuticals Inc. is to add another source of income after Chinese regulators approved Nerlynx (neratinib) to be marketed for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer.
HONG KONG – South Korea’s Hanmi Pharmaceutical Co. Ltd. has filed a new drug approval application for Rolontis (eflapegrastim) with the country’s Ministry of Food and Drug Safety (MDFS).
HONG KONG – Japan has become the first country in the world to approve Veklury (remdesivir), Gilead Sciences Inc.’s experimental drug, to treat COVID-19. The fast approval was based on U.S. data and that country’s emergency use of the drug to tackle the pandemic, although it is unclear whether the drug is safe or effective for treating COVID-19.
The latest global regulatory news, changes and updates affecting biopharma, including: Biomedical Advanced Research and Development Authority, CHMP, EMA, FDA, Gilead Sciences, National Institute for Health and Care Excellence, Nichi-Iko Pharmaceutical, Office of Special Counsel, Sagent Pharmaceuticals, SEC, Shriram Institute for Industrial Research, Therapeutic Goods Administration, U.S. Senate.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Applied Medical Resources, Cook Medical, GT Medical Technologies.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Caption Health, Cardiofocus, Cytosorbents, Helius Medical Technologies, Optiscan Biomedical, Ortho Clinical Diagnostics, Thermo Fisher Scientific, Transit Scientific.
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