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
- Early-onset colorectal cancer is behaving like a new, biologically distinct disease, researchers note
One woman’s pregnancy shows how this distinction matters - Joe Fraumeni, founder of molecular epidemiology, dies at 93
“It’s hard to imagine a world without the presence of this gentle scientific giant.” - Mt. Sinai forms committee to probe Epstein links to breast center founder Eva Dubin, other faculty members
- Is it time to re-assess the practice and practicality of screening colonoscopy?
Modeling data in ACS guideline support greater use of noninvasive tests to ease system strain, save lives - David Gius assumes role of director of the University of Cincinnati Cancer Center
