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 NIH are no longer an option? A healthier, more reliable ecosystem could form as a result of the cuts, some industry executives say. Although U.S. President Donald Trump’s policies have disrupted the nation’s scientific enterprise, some suggest that better science with the clear end-goal of getting effective drugs to patients could clear away decades of misspent funds within siloed laboratories generating duplicative research that leads nowhere. Others believe the clock is ticking, and until venture capitalists or industry provide a parachute, America’s innovation infrastructure could be irretrievably lost.

‘Everything is possible’: Pharmas navigate US market uncertainties

“We are prepared for every scenario, even though we don’t know what some of those are.” That sums up the message from executives of Astrazeneca plc, GSK plc and Sanofi SA, when quizzed during presentations of their first-quarter 2025 results this week, about the fallout if pharmaceuticals they import to the U.S. are subject to tariffs.

Dimerix strikes $601M Amicus deal for kidney disease drug DMX-200

Dimerix Ltd. sealed an exclusive license agreement with Amicus Therapeutics Inc. for commercialization of its phase III kidney disease candidate, DMX-200, in a deal valued at AU$940 million (US$601.22 million). “The deal announced today is likely to be one of the largest licensing deals in the history of Australian biotech, with four commercial deals totaling approximately AU$1.4 billion in up-front and potential development and sales milestones,” Dimerix CEO Nina Webster said during a May 1 conference call with analysts.

With new leadership, Creyon enters a $1B-plus deal with Lilly

Less than a week after announcing it had a new CEO, privately held Creyon Bio Inc. began a licensing and research partnership with Eli Lilly and Co. Creyon is getting $13 million up front and could bring in more than $1 billion in milestone payments. The two plan to find, develop and commercialize RNA-targeted oligonucleotide treatments for a range of diseases. On April 23, Creyon named Serge Messerlian, a veteran of DCVC Bio, Teon Therapeutics Inc. and a former president of Janssen Oncology. Lilly’s stock (NASDAQ:LLY) was down 10.6% to $804.19 per share at midday after missing street expectations on its first quarter of 2025 earnings.

Astrazeneca, Urogen, U of Iowa roll out new bladder results at AUA

The recent meeting of the American Urological Association in Las Vegas included an array of data in bladder cancer. C.G. Oncology Inc. wowed Wall Street with phase III findings from a trial that tested cretostimogene grenadenorepvec in non-muscle invasive bladder cancer (NMIBC), but others are busy in the space, too. Players include Urogen Pharma Ltd. and Astrazeneca plc. Compelling data from the academic world came in the form of the University of Iowa’s results in NMIBC with gemcitabine followed by docetaxel in patients where Bacillus Calmette Guerin treatment doesn’t work.

FDA clears Satsuma’s Atzumi for migraine

Following a complete response letter last year, Satsuma Pharmaceuticals Inc. received U.S. FDA approval of dihydroergotamine (DHE) nasal powder to treat acute migraine with or without aura. Branded Atzumi, it is the first product that uses Satsuma’s SMART (Simple MucoAdhesive Release Technology) platform that combines an advanced powder and device technology aimed at making delivery more simple. DHE was first approved in 1946 and has been recommended in first-line acute treatment of migraine, but liquid nasal spray and injectable products have created what Satsuma says are “invasive and burdensome administration and/or suboptimal clinical performance” that has limited their widespread use.

US HHS touts government-led vaccine development

In a paradigm shift away from biopharma partners, the U.S. Department of Health and Human Services (HHS) and the NIH today announced 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 new platform, fully developed by the NIH and government-owned, “extends vaccine protection beyond strain-specific limits and prepares for flu viral threats – not just today’s, but tomorrow’s as well – using traditional vaccine technology brought into the 21st century,” NIH Director Jay Bhattacharya said. Noting that the platform is free from “commercial conflicts of interest,” HHS and NIH said it will “recalibrate America’s pandemic preparedness” and realign operations of the Biomedical Advanced Research and Development Authority.

100 days of uncertainty 

Massive terminations. Axed programs. Canceled grants and contracts. Communication freezes. Threats and more threats of tariffs. Lawsuit upon lawsuit. Policy whiplash. The first 100 days of the Trump administration have been nothing short of chaotic, both in the U.S. and throughout the world. Shining a light through the uncertainty, BioWorld continues to cover the administration’s latest policy decisions and actions affecting the life sciences sector, as well as their impacts across the globe.

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Addex, Altamira, Augustine, Briacell, Cellectar, Creyon, Eli Lilly, Engine, Entrada, Er-Kim, Essential, Henlius, Immunic, Incyclix, J&J, Napo, Ono, Puma, Q32, Rakovina, Roche, Sandoz, Sinntaxis, Tharimmune, Therini, Trisalus, Vesicor, Xencor