The U.S. FDA has 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. Given as a single intramuscular injection, Abrysvo is composed of two antigens from RSV A and B strains, the two primary RSV subtypes, and is designed to be administered at 32 through 36 weeks gestational age of pregnancy to prevent lower respiratory tract disease and severe LRTD caused by RSV.

Incannex to begin pivotal trials in US for synthetic cannabinoid for sleep apnea 

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. The company said the U.S. FDA cleared the firm’s IND for to assess the effect of IHL-42X in patients with obstructive sleep apnea who are non-compliant, intolerant or naïve to continuous positive airway pressure, or CPAP, treatment. The phase II/III trial is expected to begin in the third quarter of 2023.

With hold lifted, Fulcrum restarts phase Ib of FTX-6058 in sickle cell disease

Shares of Fulcrum Therapeutics Inc. shot up 45% in midday trading 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. The oral small-molecule inhibitor of embryonic ectoderm development (EED), which is part of the polycomb repressive complex 2 (PRC2) complex, has both fast track and orphan drug designations in the U.S. It aims to induce expression of fetal hemoglobin (HbF) to compensate for the mutated adult hemoglobin found with sickle cell disease, thereby reducing or eliminating symptoms. The FDA issued the clinical hold in February 2023 based on preclinical data submitted in 2022, as well as evidence of hematological malignancies found with other PRC2 inhibitors. Fulcrum’s stock (NASDAQ:FULC) rose $1.77 on the news and was trading at $5.68 at midday.

BI joins the ongoing legal battle against the Inflation Reduction Act

Boehringer Ingelheim GmbH is the latest company to dive into the 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, by violating the due process clause and the just-compensation portion of the U.S. constitution’s fifth amendment. Filed in the U.S. court for the district of Connecticut, the suit is targets HHS, CMS and their respective secretary and administrator. Asking for injunctive relief, the company said in the brief the program upends the government’s incentive framework for drug development by compelling manufacturers “on pain of astronomical fines” to provide Medicare participants with “access” to drugs at below-market rates dictated by CMS. By doing that, the brief continued, the mandates “eviscerate” incentives needed to develop new drugs while causing “serious, irreparable harm” to the company and patients. In June, other suits against the act were filed by Merck & Co. Inc., Bristol Myers Squibb Co., the Pharmaceutical Research and Manufacturers of America, the National Infusion Center Association and the Global Colon Cancer Association.

US judicial advisory committee ponders streamlined rules for attorney-client privilege

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.

BioWorld Insider Podcast – The struggle is real: The first half of 2023 was an uphill climb

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.

Also in the news

Actimed, Adverum, AI Therapeutics, Alligator, Amber Ophthalmics, Anebulo, Aravive, Arthrosi, Astrivax, Bitt, Bloomsbury Genetic Therapies, Cabaletta, Calliditas, Canariabio, Eilean, Exavir, Exelixis, Foundery, Geron, Gilead, Grander, Hutchmed, Ideaya, Ipsen, Jiangsu Hengrui, Lava, Mycovia, Neurocrine, Neuronascent, Oxford Biomedica, Paradigm, Phathom, Polarityte, Promis, Psyence, Recce, Redx, Regeneron, Revive, Sanyou, Simcha, Skye, Teva, Tonix, Verismo, Vistagen