FDA approves a new cancer drug, Vidaza, and two sNDAs, without going to ODAC. A date with ODAC may signal a weak case for drug approval, recent approval data indicate.
Also in this 8-page issue: Cooperative groups tell Congress that NCI’s $115 million in support for adult cancer clinical trials is “chump change.” Trials would close faster, report results sooner, if funding were increased, regulatory issues streamlined.
Larry Norton wins ASCO’s Karnofsky award.
Funding opportunities listed.
May issue of Business & Regulatory Report, 8 additional pages, included.
Trending Stories
- As his Senate testimony alleged danger from mRNA COVID vaccine, El-Deiry had an offer to run NCI Frederick lab
The job offer to run the lab—home to virus research, RAS Initiative, and data science—was quickly rescinded - Peter F. Garrett to people with cancer: Your story has power
- OMB proposed rule could end 50% of currently active clinical trials, Stand up for Science analysis finds
- Proposed OMB rule aims at the heart of the U.S. research enterprise—and scientists are fighting back
“The question isn’t whether politics will influence research. Under this proposal, that’s the point. That’s their goal.” - What NHS-Galleri taught us—and what it didn’t
- The NHS-Galleri trial has and will continue to provide critical insights to refine future MCED studies
