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
- Mt. Sinai forms committee to probe Epstein links to breast center founder Eva Dubin, other faculty members
- GRAIL presses on with Galleri test despite missed primary endpoint in pivotal study
Where GRAIL sees signals of benefit in the subgroups, screening experts see signs of overdiagnosis - Vinay Prasad, oncologist and Twitter star, locked in debate over precision medicine
- GRAIL’s Megan Hall: “I think we can be confident that there is clinical benefit to implementing this technology. And I think that’s really hard to argue with.”
Mainstream epidemiologists beg to differ - One result, two reactions: GRAIL’s Hall and NCI’s Castle react to negative NHS-Galleri trial outcome
- NCI’s Philip Castle on NHS-Galleri results: “I’m sorry that it didn’t work, but it keeps the national conversation going.”
Castle is “disappointed” by Galleri results but not discouraged by implications for MCDs
