From Feb. 10, the U.S. NIH is to cut the amount of its grants that go to indirect costs, in a move it says will save $4 billion per annum, but which scientists say will hit breakthrough biomedical research. The NIH announced the cut on Friday, Feb. 7, saying there would be a flat rate of 15% for indirect costs, such as running laboratories, buying and maintaining equipment, data processing and storage, across all of its grants. That compares to an average rate historically of between 27% and 28%, the NIH said. The effect will be immediate, with the NIH noting its policy allows it to “deviate from the negotiated rate” for overhead costs both for future grant awards and “in cases of grants to institutions of higher education, for existing grant awards.”
BIO CEO 2025: Promising science and other things investors look for
Raising money to advance promising science is a constant struggle, bringing executive leadership together to share strategies and success stories at the Biotechnology Innovation Organization's CEO and Investor Conference in New York. " We're bottoms up investors. If we like the technology, we like the product, we think it's going to work, we want to find a way to invest, "said Chris Garabedian, chairman and CEO of Xontogeny. The conference runs through Tuesday.
Olix wins $630M deal from Eli Lilly for phase I MASH asset
Olix Pharmaceuticals Inc. walked the talk in realizing a new $630 million licensing deal with Eli Lilly and Co. for its cardiovascular and metabolic disease asset, OLX-702A (OLX-75016), rallying stock by 30% after it had largely recovered from a terminated deal with France’s Thea Open Innovation last year. Under the terms of the collaboration and licensing agreement announced Feb. 7, Olix out-licensed exclusive worldwide development and commercialization rights to OLX-75016, currently in an Australia-based phase I study and under development for various indications, including liver fibrosis and metabolic dysfunction associated steatohepatitis.
Pliant stock plunges on pause of phase IIb IPF study
Shares of Pliant Therapeutics Inc. (NASDAQ:PLRX) sank $4.73, or 60%, to trade at $3.06 on word that, after a prespecified review and recommendations by the trial’s independent data safety monitoring board, the company has voluntarily paused enrollment and dosing in the ongoing idiopathic pulmonary fibrosis (IPF) trial called Beacon-IPF. The phase IIb effort is testing bexotegrast, which blocks the activation of transforming growth factor-beta. Patients already signed up will remain in the trial, Pliant said.
4D’s new data in wet AMD bolster its phase III study plan
4D Molecular Therapeutics Inc.’s gene therapy, 4D-150, in wet age-related macular degeneration (wet AMD) produced positive phase IIb data as the company preps for two phase III studies to begin this year. Initial interim results from the phase IIb Prism study’s extension cohort of broad wet AMD patients showed an 83% drop in the number of anti-VEGF treatments they received. Those treatments require multiple injections in a year. The patient populations for the upcoming phase III studies are similar. 4D-150 combines the vector R100 with a transgene cassette expressing aflibercept (Eylea, Regeneron Pharmaceuticals Inc.) and a VEGF-C inhibitory RNAi element.
Biosecure gets new life with new name
The Biosecure Act may have died with the 118th U.S. Congress, but the intent behind the bill is being revived in the Stop Funding our Adversaries Act that was introduced in the House Friday. Sponsored by Rep. Claudia Tenney, R-N.Y., the bill would prohibit direct and indirect federal funding of research in China or entities owned by China. The legislation, if passed, “will end all American taxpayer-funded research in China and the Chinese Communist Party, ensuring we are not funding the technical, military or economic advancement of our adversaries,” Tenney said.
Critics of Super Bowl Rx ad call for new playbook
Amid a strengthening offensive against direct-to-consumer (DTC) drug ads, two senators flagged a Superbowl ad promoting compounded drugs as part of its attack on the U.S. weight-loss industry that it said was built to keep Americans “sick and stuck.” While the Hims & Hers Health Inc.’s ad didn’t mention a specific product, Sens. Dick Durbin, D-Ill., and Roger Marshall, R-Kan., called for the FDA to scrutinize the ad, noting that “nowhere in this promotion is there any side effect disclosure, risk or safety information as would be typically required in a pharmaceutical advertisement.” The bipartisan duo also announced their intention to introduce legislation to close any loopholes that might allow DTC ads for compounded drugs to play by different rules than those that apply to FDA-approved products.