In keeping with the congressional practice of passing major NIH reform legislation every 10 years, the U.S. Senate Health, Education, Labor and Pensions (HELP) Committee took the first step in looking at what can be for the NIH while unburdening it from what has been over the past few years.
Affinia Therapeutics Inc. has obtained IND clearance from the FDA for AFTX-201, an investigational genetic medicine for the treatment of BAG3-associated dilated cardiomyopathy (DCM). The phase I/II UPBEAT trial will begin in the first half of this year.
Looking to fill a treatment gap, the U.S. Biomedical Advanced Research and Development Authority (BARDA) is launching the first stage of a $100 million prize competition to support development of broad-spectrum, small-molecule antiviral therapies targeting viruses in the Togaviridae and Flaviviridae families.
Looking to fill a treatment gap, the U.S. Biomedical Advanced Research and Development Authority (BARDA) is launching the first stage of a $100 million prize competition to support development of broad-spectrum, small-molecule antiviral therapies targeting viruses in the Togaviridae and Flaviviridae families.
Reauthorization of the rare pediatric disease priority review voucher (PRV) was included in the spending package signed into law Feb. 3 by U.S. President Donald Trump, removing at least one aspect of uncertainty facing rare disease companies, many of which have relied on the PRV’s transferrable option as a lucrative source of funding.
Amgen Inc.’s head of R&D James Bradner said his firm was “surprised” by the request from the U.S. FDA Jan. 16 to take Tavneos (avacopan) off the market – and the company said no. “We're in discussions with FDA, and we'll answer questions as we talk with them,” he added.
In a one-two-punch to pharmacy benefit managers (PBMs), the U.S. FTC announced Feb. 4 what it’s calling a “landmark settlement” with the Cigna Group’s Express Scripts Inc. and its affiliates that will require fundamental changes to the company’s business practices.
The U.S. FDA released the latest version of its premarket cybersecurity guidance regarding medical devices, replacing the 2025 edition and offering recommendations on implementing measures for preventing digital attacks or authorized access.
Prelude Therapeutics Inc. has received IND clearance from the FDA for PRT-12396, a mutant-selective JAK2 V617F inhibitor being developed for the treatment of patients with certain myeloproliferative neoplasms.
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