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
- Backlog of work grows at NIH as staff members are being hounded to quit
- In the Headlines: What are Jay Bhattacharya’s plans for NIH?
- Rathmell: My mentor recognized a cliff I was going to fall off before I did.
“He was there to stand with me while I fell, and then made me look up and see that I needed to lean into the experience.” - The Directors: Ray DuBois and Roy Jensen on how COE guides cancer care in rural America
“We’re just going to have to ride through this and not give up.” - In support of three coordinated CCSG components reducing our national burden of cancer
- In the Headlines: Could “flooding the zone” drown NIH and cancer centers?