Unless the U.S. Supreme Court steps in to reverse the decision, the NIH’s attempt to cap indirect costs at 15% in all its grants is dead. The U.S. Court of Appeals for the First Circuit upheld a permanent injunction Jan. 5 that was issued by a lower court, vacating an NIH supplemental guidance imposing the across-the-board cap both retroactively and prospectively.
The newly released 2026 edition of Clarivate’s Drugs to Watch report highlights 11 potential blockbusters that could change treatment paradigms for patients.
Eye disease specialist Oculis SA is laying plans to branch out into multiple sclerosis (MS) after the phase II trials of its acute optic neuritis (AON) drug, privosegtor, showed it reduced levels of neurofilament release, a key biomarker of neuronal damage and neurodegeneration.
It doesn’t take a meteorologist to predict another stormy year for the biopharma sector, not just in the U.S., but also in Europe. Lurking within those storms, though, could be a few silver linings.
Biopharma industry zeal for obesity therapeutics does not appear to be dying down any time soon, with Eli Lilly and Co. entering a $1.3 billion deal with Nimbus Therapeutics LLC for a new small molecule, and Arrowhead Pharmaceuticals Inc. rolling out phase I/IIa data of its RNAi therapeutics used in combination with Lilly’s GLP-1/GIP receptor agonist tirzepatide.
Stereotaxis Inc. secured U.S. FDA approval for its Magic magnetic interventional ablation catheter, marking a key step in the company’s effort to evolve from a niche robotics supplier into a more vertically integrated electrophysiology technology provider. The approval positions Magic as Stereotaxis’ first proprietary robotic ablation catheter in the U.S. and follows a series of regulatory and commercial milestones in recent months that reset the company’s growth narrative.
Naox Technologies SAS secured U.S. FDA 510(k) clearance for Naox Link, its in-ear electroencephalography (EEG) device for clinical use both at home and in health care settings. Naox Link is a pair of earbuds the company hopes will transform how the brain activity is monitored, helping diagnose and track a number of conditions affecting the brain.
Software as a service has typically been less susceptible to liability than products, but that may soon come to an end if the AI LEAD Act, sponsored by a bipartisan pair of members of the Senate, gains sufficient traction.
With the stroke of a pen and no input from the CDC’s Advisory Committee for Immunization Practices, acting CDC Director Jim O’Neill cut the number of vaccines the agency routinely recommends for children to 11 on Jan. 5, down from 17 in 2024.
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