Christian Brothers Contracting Corp. President Jason Vale was sentenced June 18 to 63 months in prison and three years of supervised release for selling Laetrile, a bogus cancer cure, the U.S. District Court of the Eastern District of N.Y. ruled. Laetrile, also known as amygdalin, vitamin B-17 and "apricot pits," is "a highly toxic product that has not shown any effect on treating cancer," FDA says. Vale was convicted last July of three counts of criminal contempt for violating a 2000 court order to cease sale and promotion of Laetrile (1"The Tan Sheet" July 28, 2003, In Brief)...
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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Vinay Prasad’s exit from the US FDA reignited conversations about integrating its drugs and biologics centers under George Tidmarsh. Those plans appear to be shelved, but the leadership transition could be an opportunity to fully realize the vision for the Oncology Center of Excellence.
The Pink Sheet viewed Stealth's complete response letter and other documents indicating the FDA appears willing to grant accelerated approval to elamipretide before a confirmatory trial begins enrolling. But the company says it needs a two-month review of the NDA resubmission to survive.