HONG KONG – Japan’s Ministry of Health, Labour and Welfare (MHLW) ended the first half of 2020 by handing out a flurry of approvals to both domestic and international companies across a wide spectrum of indications.
The latest global regulatory news, changes and updates affecting biopharma, including: Alcon, Gilead Sciences, Institute for Clinical and Economic Review, Novartis, SEC.
HONG KONG - Mumbai-based Glenmark Pharmaceuticals Ltd. has been granted manufacturing and marketing approval for the launch of its antiviral drug, favipiravir, for the treatment of mild to moderate COVID-19, a move it deems a “landmark development for COVID-19 patients in India.”
The latest global regulatory news, changes and updates affecting biopharma, including: Auromedics, Bring Entrepreneurial Advancements to Consumers Here In North America, Central Drugs Standard Control Organisation, FDA, Gilead Sciences, Medicines and Healthcare products Regulatory Agency, NIH, Pharmaceutical and Medical Devices Agency, Somerset, Therapeutic Goods Administration, U.S. Patent and Trademark Office.
The latest global regulatory news, changes and updates affecting biopharma, including: Department of Defense, FDA, Minister of Health, National Center for Advancing Translational Sciences, NIH.
HONG KONG – India’s Ministry of Health and Family Welfare (MOHFW) has drafted rules for the manufacturing, import and the compassionate use of unapproved drugs in the treatment of patients.
Chinese biotech firm Beigene Ltd. said its second-generation BTK inhibitor, Brukinsa (zanubrutinib), has won approval in China for two indications, entering a market dominated by Imbruvica (ibrutinib, Johnson & Johnson/Abbvie Inc.). The NDA approval came eight months after Brukinsa’s clearance in the U.S.
The latest global regulatory news, changes and updates affecting biopharma, including: Biomedical Advanced Research and Development Authority, Biotechnology Innovation Organization, Council of State Bioscience Associations, FDA, HHS, U.S. Department of Agriculture, U.S. House, U.S. House Select Subcommittee on the Coronavirus Crisis, U.S. Senate.
LONDON – The World Health Organization (WHO) is stepping up its effort to try and ensure equitable access to any approved COVID-19 vaccines and therapies, putting in place a system for sharing all intellectual property, information and clinical trials data needed to enable generic manufacturing.
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