After a two-day session of the FDA’s Vaccines and Related Biologic Products Advisory Committee, the U.S. is within days of a long-awaited milestone of having not just one but at least two vaccines available for nearly every American. The VRBPAC voted unanimously, 21-0, June 15 to support amending the emergency use authorizations for both the Moderna Inc. and Pfizer Inc.-Biontech SE COVID-19 mRNA vaccines to allow their use in children 6 months and older. Read More
A day after announcing it would pump $120 million into a Michigan manufacturing facility for Paxlovid (nirmatrelvir/ritonavir), Pfizer Inc. produced new data it plans to use in an U.S. NDA submission for treating COVID-19. While some data for the oral antiviral fell short of statistical significance, other companies are not far behind Pfizer in their drive for FDA acceptance using similar 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
Quoted European tech investor Gimv is setting up an independent life sciences arm and said it will increase both the size of its investments and the number of companies it backs. Read More
The FDA’s Psychopharmacologic Drugs Advisory Committee posted briefing documents related to the June 17 meeting, set to consider Acadia Pharmaceuticals Inc.’s sNDA for Nuplazid (pimavanserin) to treat hallucinations and delusions associated with Alzheimer’s disease psychosis (ADP). Although shares of the San Diego-based firm (NASDAQ:ACAD) stayed in the black, closing at $18.77, up $2.52, or 15.5%, the briefing docs did not bring uniformly good news, echoing some of the concerns spelled out in an earlier complete response letter. Read More
The U.S. Supreme Court shot down a rule June 15 that allowed the Department of Health and Human Services (HHS) to sharply reduce Medicare reimbursement for Part B drugs to hospitals participating in the 340B prescription drug discount program. Read More
New hires and promotions in the biopharma industry, including: Allarity, Avilar, Cerevel, Epiendo, Kamada, Lava, Lixte, Marengo, Scisparc, Visiox. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Actinogen, Biomarin, Clover, Codagenix, Exscientia, Freeline, Genexine, Huyabio, Puretech, Soleno, Treadwell, Zhimeng. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Blue Earth, Boehringer, Contrafect, Evotec, Hemostemix, Heron, Hibio, Incyte, J&J, Jupiter, Maia, Morphosys, Oragenics, Pfizer, Pike, Precerv, Telix, Trutino, Vyluma. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alnylam, Attgeno, Cellenkos, Eli Lilly, Incyte, Innovent, Moderna, Nammi, Outlook, Stealth, Tremeau. Read More
