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
- Maura Gillison, who identified the role of HPV in head and neck cancer, changing the standard of care, dies at 61
- Cancer patients with Medicare Advantage have access to fewer providers than Medicare patients, cross-sectional study finds
- Did peer review fail? Nature Medicine’s chronotherapy paper retraction raises questions
- A chronotherapy study in Nature Medicine showed dramatic results. Then it was retracted.
The phase III trial claimed a staggering boost to OS and PFS when immunochemotherapy was given before 3 p.m. - OMB’s plan to increase political control of science faces stiff opposition on Capitol Hill
- A new diagnostic lens—and a lasting scientific legacy









