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.
The latest global regulatory news, changes and updates affecting biopharma, including: Biomedical Advanced Research and Development Authority, EMA, FDA, House Energy and Commerce Subcommittee on Oversight and Investigations, International Coalition of Medicines Regulatory Authorities, National Institutes of Health, Trump administration, World Health Organization.
BEIJING – Shandong, China-based Luoxin Pharmaceuticals Group Stock Co. Ltd. said its PIK3α inhibitor, LX-086, has been approved by China’s National Medical Products Administration (NMPA) to enter clinical trials for advanced solid tumors.
HONG KONG –Shanghai-based Zai Lab Ltd. has won an approval for the first innovative treatment for glioblastoma approved by China in more than 15 years, with the National Medical Products Administration’s nod for Optune in combination with temozolomide for use in patients with newly diagnosed glioblastoma.
The latest global regulatory news, changes and updates affecting biopharma, including: Cybersecurity and Infrastructure Security Agency, EMA, European Commission, FBI, FDA, Glaxosmithkline, National Institute for Health and Care Excellence, NIH, U.K. National Cyber Security Agency, U.S. Department of Justice.
RSS
