Looking to shave $65 million from its annual expenditures while streamlining the first stage of its two-level grant review process, the U.S. NIH is proposing to centralize the peer review of all applications for grants, cooperative agreements and R&D contracts within its Center for Scientific Review.
In what it says is the biggest obesity deal to date, Zealand Pharma A/S has signed up Roche AG to a potential $5.3 billion global collaboration and license agreement to develop petrelintide, an amylin analog that is currently in phase IIb development. The two companies will co-develop and co-commercialize petrelintide and combination products, including a fixed-dose combination of petrelintide and CT-388, Roche’s dual GLP-1/GIP receptor agonist.
Finnish cancer immunotherapy specialist Valo Therapeutics Oy has raised €19 million (US$20.7 million) in a round that attracted Italian and Australian investors, and funding the company to the completion of the ongoing phase Ib trial of its lead program in the treatment of solid tumors.
Getting the Ensuring Pathways to Innovative Cures (EPIC) Act through the U.S. Congress to do away with the “pill penalty” in the Medicare drug price negotiations could require an epic effort, given the current politically fueled atmosphere on the Hill. With the Inflation Reduction Act (IRA), which created the negotiations, considered a signature achievement of the Biden administration, the negotiations have become, for many lawmakers, almost a sacred cow that can’t be touched. If anything, some of them want to expand the negotiations to more drugs and to the commercial market.
Three public health experts have voiced concerns that the uncertainties sparked by the Trump administration’s moves to reduce federal spending could limit the U.S. CDC’s ability to track and respond to infectious disease outbreaks and will undermine the public health support system in the U.S.
While the U.S. has historically led the global pharmaceutical industry by pursuing both continual innovation and high quality, those strengths could become areas of weakness in times of political uncertainty, according to PA Consulting expert Andy Prinz.
Several drugs already selected for Medicare price negotiations, including Novo Nordisk A/S’ mega-blockbuster diabetes/weight-loss franchise, could see up to a three-year reprieve if a bipartisan bill recently introduced in the U.S. House and Senate becomes law.
Martin Makary, President Donald Trump’s pick to head the U.S. FDA, took his turn before the Senate Health, Education, Labor and Pensions (HELP) Committee March 6, a week ahead of the committee’s confirmation votes on both him and Jay Bhattacharya as the next NIH director. The committee votes will set the stage for the full Senate to vote on confirming both nominees later this month.
Jay Bhattacharya will have his work cut out for him if he wins confirmation as the next director of the U.S. NIH. Besides getting NIH committees back on track to evaluate grant applications and calming the fears of researchers and other staff who have seen about 1,200 colleagues cut from their ranks in recent weeks, Bhattacharya will face the task of rebuilding public trust in the NIH itself.
The executive orders (EOs) pouring out of the Trump White House, and the resulting court challenges, continue to pile up, deepening the uncertainty hanging over the life sciences sector and the U.S. economy in general.