In a paradigm shift from private-sector partners, the U.S. Department of Health and Human Services (HHS) and the NIH announced May 1 the development of Generation Gold Standard, a next-generation, universal vaccine platform that uses a beta-propiolactone-inactivated, whole-virus to target pandemic-prone viruses.
The Trump administration’s broad slash to university research budgets raises pertinent questions over impacts to the biopharma ecosystem, specifically how a changed trajectory of early research programs will affect tomorrow’s treatments and cures. Who is going to bridge research from idea to company if grants from the U.S. NIH are no longer an option?
If the April 30 hearing on biomedical research before the U.S. Senate Appropriations Committee is any indication, the Trump administration could face a big challenge if it tries to cut more than 40% of the NIH’s budget in fiscal 2026 as proposed and slap a 15% cap on indirect costs.
The National Institutes of Health (NIH) is adopting a new initiative to expand innovative, human-based science while reducing animal use in research. Developing and using alternative nonanimal research models aligns with the FDA’s recent initiative to reduce testing in animals.
On Jan. 21, economist Jay Bhattacharya spoke publicly for the first time since becoming the current NIH director, addressing the NIH Council of Councils in an open session. The goal of Bhattacharya’s remarks seemed to be to reassure troubled staffers. His reassurances, however, were given in the face of another blow to NIH research.
As pharma deals with the impact of U.S. NIH grant cuts and the imposition of tariffs, a lot of pressure is shifting to smaller and midcap companies, according to two executives who spoke on the newest BioWorld Insider podcast.
The next major shock wave to hit the U.S. biopharma and med-tech industries could be the fiscal 2026 federal budget. Nearly one-third of the discretionary budget for the Department of Health and Human Services (HHS) could be wiped out, according to the White House Office of Management and Budget’s “pre-decisional” budget proposal, or passback, for HHS.
The U.S. NIH published the results of a study of the use of AI in referring patients for intervention for risk of opioid use disorder, which found the algorithm helped stave off hospital admissions.
Ill-considered government policies, pharmacy benefit manager market abuses and an unpredictable future are casting doubt on the long-term sustainability of the U.S. biosimilar market, Craig Burton, the executive director of the Biosimilars Council, told a House Ways & Means subcommittee April 8.
The nationwide preliminary injunction keeping the U.S. NIH from slashing its indirect cost rate to a flat 15% has become permanent. In issuing the permanent injunction and final judgment April 4 in three challenges to the rate change, Judge Angel Kelley, of the U.S. District Court for the District of Massachusetts, said the NIH’s Feb. 7 notice that it would begin imposing the 15% rate Feb. 10 to all existing and future grants violated the Administrative Procedure Act, as the action was arbitrary and capricious, was impermissibly retroactive and failed to follow notice-and-comment procedures.