While the World Trade Organization (WTO) is taking a victory lap for getting a five-year intellectual property (IP) waiver across the finish line for COVID-19 vaccines, the accomplishment is being panned by spectators on both sides of the track. Read More
China’s National Medical Products Administration (NMPA) approved Ocumension Therapeutics Ltd.’s and Eyepoint Pharmaceuticals Inc.’s drug-device combination product, Yutiq (fluocinolone acetonide intravitreal implant), for chronic non-infectious uveitis affecting the posterior segment of the eye. Read More
China will continue to ramp up volume-based procurement (VBP) policies that bring down drug and device prices for public hospitals with volume. Governmental agencies at the local and national levels coordinate drug prices via government-organized procurement programs that include VBP and pricing negotiations for inclusion on the National Reimbursable Drug List. Read More
Meta Pharmaceuticals Inc. has raised $15 million in seed and pre-series A rounds in six months for the pipeline and AI platform development. Shenzhen, China-based Meta Pharma plans to use the new funds to support its three candidates to enter clinical trials, as well as the development of its Meta-map platform for pipeline expansion. Read More
The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) is still considering a drastic overhaul of the 2002 medical device regulatory framework, but may have sent a signal that its new framework won’t deviate too far from established regulatory approaches. Read More
With just 10% of therapeutic programs successfully moving from first toxicity dose to market, drug developers are on a constant hunt for new tricks to put the odds in their favor. Strategies abound, from biomarker-guided patient selection to deeper regulatory engagement. But big pharma executives and an academic expert weighing the challenge at the BIO International Convention said June 14 they see another tool slowly gaining traction with the potential to decrease timelines and boost chances for approval: in-silico modeling. Read More
New and updated preclinical and clinical data presented by biopharma firms at the European Hematology Association Congress, including: Ascentage, Canbridge, Daiichi Sankyo, Iaso, Innovent Biologics. Read More
Biopharma happenings in Asia-Pacific, such as deals and partnerships, grants, preclinical data and other news in brief: Basilea, Boehringer Ingelheim, Human Immunology Biosciences, I-Mab, Invicro, Morphosys, Oragenics, Pfizer, Quoin, Telix, Valneva. Read More
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: ABVC, Beigene, Biontech, Innovent Biologics, Kazia, Moderna, Novavax, Nrx, Pfizer, Relief. Read More
