Just days after U.S. FDA advisors unanimously backed use of both the Moderna Inc. and Pfizer Inc.-Biontech SE COVID-19 vaccines in children 6 months and older, the FDA has expanded emergency use authorizations for the products. Availability could follow as soon as June 21, after a meeting of the CDC’s ongoing Advisory Committee on Immunization Practices, wraps up June 18. Read More
The U.S. FDA’s Psychopharmacologic Drugs Advisory Committee took up the complicated matter of Acadia Pharmaceuticals Inc.’s sNDA for Nuplazid (pimavanserin) to treat hallucinations and delusions associated with Alzheimer’s disease psychosis (ADP). Read More
Shares in Addex Therapeutics Ltd. (Zurich:ADXN) dropped 48% June 17 on news that the company had terminated a pivotal phase IIb/III study of dipraglurant as a potential treatment for dyskinesia in Parkinson’s disease. 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
Amid a convergence of demographic, economic and technological trends, more workers are engaged in U.S. life sciences research than ever before, a new analysis of U.S. Bureau of Labor Statistics shows. The analysis, by commercial real estate giant CBRE Group Inc., found that even with a doubling in the number of U.S. graduates in biological and biomedical sciences since 2005, biopharma companies continue to face major challenges finding talent and, increasingly, space in which to put that talent to work. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aquestive, Bavarian, Checkpoint, Cytokinetics, Galecto, Moleculin, Plus, Roche, Sirnaomics, Vicore. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aqemia, Bioasis, Cancer Prevention, Cornerstone, Cresence, Inmune, Invectys, Lenire, Novartis, Panbela, Pharmadrug, Pliant, Sanofi. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ABVC, Hansa, Savara. Read More
