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
- On Capitol Hill, NIH gets congressional support and RFK Jr. gets slammed
- Jonathan Mahler on his front-page story in the NYT Magazine on Trump’s deliberate dismantling of America’s War on Cancer
- The Directors: Ben Ho Park and Suresh Ramalingam discuss tough times, uncertainty, and resilience
“If you’re going to be an oncologist, we look at the glass 5% full, not 95% empty.” - After stormy Senate hearing, Trump offers tepid support for RFK Jr. while Kennedy family members call for his ouster
- Reflections of a cancer scientist
Maintaining the pace of novel technologies will lead to more efficient and less toxic medicines - Bonnie Addario, lung cancer survivor and advocate, dies at 77