> China-focused Cellular Biomedicine Group (CBMG) said a GMP manufacturing facility in the PKUCare Industrial Park of Beijing has officially opened. The facility will handle clinical batch production and commercial scale manufacturing and has received certification from the Beijing Institute for Drug Control, accredited bodies of the China National Accreditation Service and China Metrology Accreditation. California-headquartered CBMG is developing stem cell products for joint and autoimmune disorders, and has in-licensed CAR-T immuno-oncology technology from the Chinese PLA General Hospital of Beijing. Report
> Orthozon Technologies said it has signed a distribution agreement with GM Medical Pacific for GM to be the exclusive distributor of Orthozon's LUMIERE spinal surgery system. Release
> India will ease rules and regulations governing testing of new drugs to place more responsibility on ethics committees that vet clinical trials, according to a report by the Economic Times. Report
> China-focused oncology biotech DelMar Pharmaceutical presented additional data candidate VAL-083 in molecular signaling events that were coordinated with other researchers and said it will offer a poster presentation at the 20th Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology being held Nov. 19 and 20 to update on the candidate. In October the company expanded its Phase II clinical study of VAL-083 to full enrollment. Release
> Taiwan's ScinoPharm Changshu China manufacturing site in Jiangsu province successfully completed a U.S. FDA cGMP inspection, the company said in a press release, adding that the plant has also received Mexican regulatory authority approval. "The current FDA inspection focused primarily on in-depth examinations of the raw material management, production operations, and the quality assurance and control systems for the active pharmaceutical ingredients (APIs) and intermediates produced at the plant. After the inspection, the FDA concluded that the quality management systems at ScinoPharm's Changshu Plant met the requirements of the U.S. cGMP standards," the company said. Release
> U.S.-based Akers Biosciences won a nod from the China FDA for a diagnostic test, the PIFA Heparin/PF4 Rapid Assay, for allergic reactions to blood thinner heparin, marking a first for any such product on the Mainland. Beijing-based firm NovoTek will distribute the product. Release
> The American College of Cardiology has joined with Singapore's National Heart Centre to create a global diabetes registry aimed at supporting research and quality of care globally. Release