Trump’s FDA Cuts Are Putting Drug Development at Risk
New SEC filings from pharmaceutical companies reveal Donald Trump and Elon Musk’s cost-cutting measures could slow drug ...
How AI Could Revolutionize Drug Development and Save Billions
BullFrog AI plans to introduce what it considers a game-changing approach that could shorten timelines, reduce costs, and ...
Key takeaways from Marty Makary’s FDA confirmation hearing
Marty Makary, a career surgeon and President Trump’s nominee to run the Food and Drug Administration (FDA), faced senators in ...
PharmExec2d
The NIH’s Role in New Drug Development
In regard to what’s happening now with NIH, the main thing to do is diversify. You raise both non-dilutive funding through NIH which is the very best, obviously, and then as well as dilutive and to ...
Pharmaceutical Technology2d
Understanding the rules on HPAPI containment in high potent manufacturing
How to ensure safety and quality in pharmaceutical facilities when using HPAPIs in drug development. Read more here.
Business Wire5d
The US FDA Grants Both Orphan Drug and Rare Pediatric Disease Designations to NEU-001 of Neurenati for the Treatment of Hirschsprung Disease
The FDA’s Office of Orphan Drug Products grants ODD and RPDD to encourage the development of medicines ... (PRV), which can expedite the FDA review process for a future marketing application ...
Health Affairs3d
Medicare Coverage Of Medical Technologies In A New Era
Potential Medicare coverage reforms, such as eliminating Coverage with Evidence Development, would remove key policy tools ...
Euractiv5d
Bitter pill or market opportunity – how will EU pharma adapt to RFK Jr’s health reforms?
The Trump administration's comprehensive healthcare and pharma policy agenda aims to transform the US healthcare landscape, ...
GEN - Genetic Engineering and Biotechnology News3d
Jazz to Acquire Chimerix for $935M, Expanding Rare Oncology Portfolio
Chimerix’s lead clinical pipeline candidate is dordaviprone, a first-in-class small molecule treatment designed to selectively target the mitochondrial protease ClpP and dopamine receptor D2 (DRD2).
pharmaphorum2d
The role of quality assurance in accelerating drug development for emerging therapies
Regulatory agencies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines ... track and verify data throughout the development process. By implementing blockchain ...