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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It’s a high-risk bet: Insider trading, equipoise, integrity of research, public trust are at stake - Mount Sinai oncologist Krystal Cascetta, 40, and her infant daughter die in Somers, NY, home
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“There is a reason why generics have been exempt from all the tariffs until now,” Brookings economist warns
