The U.S. FDA approved Pfizer Inc.’s respiratory syncytial virus (RSV) prophylactic, Abrysvo (RSVpreF) for maternal use, providing pregnant women with the option of protecting their newborns up to the age of 6 months against RSV for the first time. The regulator’s Vaccines and Related Biological Products Advisory Committee voted 14-0 in favor of approving the BLA for maternal use of the vaccine in May, a few weeks before the agency gave it the go-ahead for use in older adults (those ages 60 and older). Read More
Incannex Healthcare Ltd. is gearing up to begin a pivotal phase II/III trial in the U.S. for its lead asset, IHL-42X (dronabinol/acetazolamide), a synthetic cannabinoid combination drug for sleep apnea. Read More
Shares of Fulcrum Therapeutics Inc. shot up 38.5% on Aug. 22 following news that the U.S. FDA had lifted the clinical hold on the company’s phase Ib sickle cell disease candidate, FTX-6058. Read More
Boehringer Ingelheim GmbH is the latest company to dive into the legal fray surrounding the federal government’s plan to change drug costs. The drug price negotiation program established by the Inflation Reduction Act is “unlawful,” according to the company’s brief, because it violates the due process clause and the just-compensation portion of the U.S. constitution’s Fifth Amendment. Read More
The U.S. FDA is in the midst of a shake-up of several major offices, including the Office of Regulatory Affairs, but its commissioner, Robert Califf, believes there are even greater issues faced by the agency. Califf said during an Aug. 22 public forum that prices for generic drugs are too low to encourage manufacturers to continue to produce these products, adding that the issue is sufficiently severe to constitute a national security risk. Read More
The process of discovery is resource-consuming in any type of litigation, but this is especially the case for patent litigation due to the exceptional importance of attorney-client privilege in patent prosecution. However, a U.S. judicial advisory committee is considering a rewrite of the rules to ease some of this burden in a move that could cut both the expense and time consumed by patent litigation, a development that is sure to draw cheers from across the spectrum of innovators in the life sciences. Read More
Guests Karen Carey, BioWorld’s managing editor, and Mike Ward, Clarivate’s global head of Life Sciences and Healthcare Thought Leadership, discuss the deals, financing and M&A landscape for the first half of 2023 and how U.K. biopharmas are faring post Brexit. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Amicus, Aravive, Cabaletta, Exavir, Grander, Lava, Neuronascent, Oxford, Paradigm, Regenetp, Revive, Sanyou, Sinorda, Teva, Verismo. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alligator, Anebulo, Arthrosi, Boston Immune, Bloomsbury, Canariabio, Geron, Gilead, Harvard Apparatus, Ideaya, Mycovia, Neurocrine, Phathom, Redx, Regeneron, Tonix. Read More
