Vir Biotechnology Inc.’s focus will look a little different for the latter half of 2024, as the San Francisco-based firm disclosed a restructuring that will cut about a fourth of its workforce and phase out programs targeting influenza and COVID-19 as well as vaccines developed using its T-cell-based viral vector platform.
Many respiratory syncytial virus (RSV) disease vaccines are for older adults but Merck & Co. Inc.’s monoclonal antibody, MK-1654 (clesrovimab), which just produced positive top-line phase IIb/III data, aims at a far smaller and younger market. Data for protecting healthy preterm and full-term infants from RSV disease show the double-blind, randomized, placebo-controlled clinical trial hit all its primary efficacy and safety endpoints, including the incidence of RSV-associated medically attended lower respiratory infection for 150 days compared to placebo.
Just a day after the U.S. FTC released an interim report on harmful pharmacy benefit manager (PBM) practices and appeared before a House subcommittee that encouraged the commissioners to take enforcement action, the agency reportedly was preparing to file suit against the country’s three largest PBMs over their practices in negotiating insulin and other drug prices.
Following an advisory committee’s recommendation in May against approval, the U.S. FDA issued a complete response letter (CRL) to Novo Nordisk A/S for its once-weekly insulin icodec injection for diabetes, which is on the market as Awiqli in several other countries.
Sanofi SA has synthesized interleukin-17A (IL-17A)/interleukin-17 receptor A (IL-17RA) interaction inhibitors reported to be useful for the treatment of psoriasis, rheumatoid arthritis, radiographic axial spondyloarthritis (ankylosing spondylitis), multiple sclerosis, asthma, chronic obstructive pulmonary disease, atopic dermatitis and systemic lupus erythematosus, among others.
Following a day of deals that collectively bring a potential $3.75 billion into three biopharma companies – namely Ascidian Therapeutics Inc., Belharra Therapeutics Inc. and Mabcare Therapeutics – researchers will be busy discovering new therapies for neurological and immunological diseases, and advancing globally a candidate for solid tumors.
Following a day of deals that collectively bring a potential $3.75 billion into three biopharma companies – namely Ascidian Therapeutics Inc., Belharra Therapeutics Inc. and Mabcare Therapeutics – researchers will be busy discovering new therapies for neurological and immunological diseases, and advancing globally a candidate for solid tumors.
Sanofi SA and Seagen Inc. have reported antibody-drug conjugates comprising antibodies targeting carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5; CEA; CD66e) covalently linked to topoisomerase I inhibitors through a linker reported to be useful for the treatment of cancer.
In lieu of pending guidance, the U.S. FDA’s approval May 20 of Biocon Biologics Ltd.’s Yesafili and Samsung Bioepis Co. Ltd.’s Opuviz as interchangeable biosimilars to Regeneron Pharmaceuticals Inc.’s Eylea (aflibercept) provides further insight into how the agency is approaching the market exclusivity the Biologics Price Competition and Innovation Act awards to the first approved interchangeable for any given biologic.
The FTC’s request for a nearly 25% increase in funding for fiscal 2025 was splashed with cold water May 15 in a U.S. House Appropriations subcommittee hearing. That’s “a dramatic increase in funding for an agency whose work continues to raise concerns among many members of Congress and the public,” Rep. David Joyce (R-Ohio), chair of the Subcommittee on Financial Services and General Government, said as he opened the hearing.
