Four Chinese biopharmaceuticals unveiled early data on respective cancer therapies at the American Society of Hematology (ASH) 2024 meet in San Diego, including Cstone Pharmaceuticals Co. Ltd.’s receptor tyrosine kinase-like orphan receptor 1 (ROR1)-inhibiting antibody-drug conjugate (ADC) in phase I study for lymphomas.
If a bipartisan group of U.S. House members has its way, at least some of the legislation congressional committees have passed to target pharmacy benefit manager (PBM) practices could yet make it into law this year. That is if congressional leaders listen to the rank-and-file members.
The U.S. FDA has greenlit the first steps of Uniqure NV’s accelerated approval pathway for gene therapy AMT-130 to treat Huntington’s disease. The agency said data from the ongoing phase I/II studies compared to natural history external control are muscular enough to get the process going without having to dive into additional studies.
In a surprise move that drove its stock up by 292% in early trading, Chimerix Inc. revealed plans for a U.S. NDA filing by year-end, seeking accelerated approval of dordaviprone (ONC-201) to treat recurrent H3 K27M-mutant diffuse glioma, a highly aggressive tumor with limited treatment options.
Third-party patent litigation funding has been a concern for device makers for some time, but a recent report by the U.S. Government Accountability Office indicates that the Department of Justice is looking into the practice for evidence that foreign entities are involved in patent litigation funding.
At its investor day conference, Edwards Lifesciences Corp. prognosticated that an expanded indication in transcatheter aortic valve replacement and rapid growth in its newer mitral and tricuspid heart valve technologies will accelerate total company sales in 2026 and beyond.
The COVID-19 pandemic reset expectations of Medicare telehealth coverage, prompting a letter from dozens of members of Congress to Capitol Hill leadership asking for legislation that will memorialize telehealth benefits. But concerns over spending, fraud and abuse still hang over the discussion.
Dewpoint Therapeutics Inc. and Mitsubishi Tanabe Pharma Corp. have entered a research collaboration worth up to $480 million to advance Dewpoint’s novel TDP-43 small-molecule condensate modulator for amyotrophic lateral sclerosis. Under terms of the deal, Boston-based Dewpoint will receive an undisclosed up-front payment and is eligible to receive R&D-based milestone payments up to $480 million. Upon reaching those milestones, Osaka, Japan-based MTPC will have an exclusive option to license the program and assume responsibility for global clinical development and commercialization. Dewpoint will also receive tiered royalties on net sales.
The Biosecure Act missed its expected ride through the U.S. Congress via the National Defense Authorization Act, but it may not be the end of the road for the bill that would prohibit direct or indirect U.S. government contracts with listed “biotechnology companies of concern.”
Less than three months after going public via a $227.7 million IPO, shares of Bioage Labs Inc. (NASDAQ:BIOA) took a hit Dec. 9, losing 77% of their value, as safety concerns prompted the company to halt its phase II trial testing oral obesity candidate azelaprag. The Strides study, launched in July, had been testing azelaprag, an oral apelin receptor agonist licensed from Amgen Inc., as a monotherapy and in combination with GLP-1/GIP therapy Zepbound (tirzepatide, Eli Lilly and Co.) in obesity.
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