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.
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The job offer to run the lab—home to virus research, RAS Initiative, and data science—was quickly rescinded - Pancreatic cancer breakthrough came from smart scientists making smart bets—not from politicization of science
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“The question isn’t whether politics will influence research. Under this proposal, that’s the point. That’s their goal.”
