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.
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.
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.
Saudi Arabia, which last year made its first appearance on the U.S. Trade Representative’s (USTR) Priority Watch List, is back on the list this year and is being singled out for an out-of-cycle review due to what the USTR calls its “unfair commercial use” and “unauthorized disclosure” of proprietary data submitted for drug approvals.
The latest global regulatory news, changes and updates affecting biopharma, including: Biomedical Advanced Research and Development Authority, COVID-19 EMA Pandemic Task Force, Cybersecurity and Infrastructure Security Agency, EMA, European Commission, FDA, Heads of Medicines Agencies, National Institute for Health and Care Excellence, NIH, Therapeutic Goods Administration, U.S. Cyber Command, U.S. House and Senate, Wuhan Institute of Virology.
BEIJING – After its masks and test kits were said to be sent back by Western countries due to complaints over poor quality, China this week required only NMPA-approved companies export their products and stepped up regulations to ensure quality.
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