About $1.7 trillion in securities of China-based issuers listed on U.S. exchanges could face trading prohibitions in as little as two years, Y.J. Fischer, director of the U.S. SEC’s Office of International Affairs, warned during remarks at the May 24 annual meeting of the International Council of Securities Associations. Read More
China’s National Medical Products Administration (NMPA) released a new draft amendment to its Drug Administration Law (DAL) that introduces some important changes to the regulatory framework and is aimed at codifying initiatives implemented in the current DAL, such as patent linkage and regulatory data protection. Read More
China has granted a green light for Glaxosmithkline plc’s human papillomavirus (HPV) vaccine, Cervarix, for girls ages 9 to 14. The HPV bivalent vaccine is used against types 16 and 18 in a two-dose course to prevent cervical cancer. It’s the first imported two-dose HPV vaccine for the age group to be approved in China, the company said. A three-dose schedule of Cervarix won Chinese approval in July 2016 for girls and women ages 9 to 25. To date, the two-dose regimen has been approved in about 100 global markets. Read More
Facing the global threat of antimicrobial resistance (AMR), the EMA issued a final revised guideline on the evaluation of new antibiotics. In accordance with an agreement with the U.S. FDA and Japan’s Pharmaceuticals and Medical Devices Agency, the EMA’s guideline aligns as much as possible with the data requirements of those regulators so drug developers can design clinical trials that meet the evidence needs of all three agencies, the EMA said. Read More
New and updated preclinical and clinical data to be presented by biopharma firms at the American Society of Clinical Oncology annual meeting, including: Adagene. Read More
Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications: Antengene, Axcella Health, Biontech, Codagenix, Edesa, Harbour, Junshi, Laekna, Moleculin, Pfizer, Visen. Read More
Biopharma happenings in Asia-Pacific, such as deals and partnerships, grants, preclinical data and other news in brief: Academab, Astrazeneca, Beijing Tianshi Tongda Pharmaceuticals Technology, Benevira, Blade, CASI, Imaginab, Insilico Medicine, Yantai Dongcheng. Read More
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Altamira, Astrazeneca, Bharat Biotech International, Cynata, Hyundai, Innocare, Ocugen, Revive. Read More
