Nothing Benign About It: BPH Drugs' Bids For Prostate Cancer Risk Reduction Voted Down By Advisory Committee
• By The Pink Sheet Daily
Reducing the risk of low-grade prostate cancers that may not affect a patient's health isn't worth the risk of increasing the numbers of high-grade tumors, ODAC says.
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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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The Clinical Trials Access Collaborative (CTAC) will build on a pilot program's work to bolster community-based clinical research infrastructure so "anyone who wants to participate in clinical trials can and do it closer to home,” CEO Tesheia Harris said in an interview.
The US MFN executive order is the latest in a series of concerning US developments that are contributing to uncertainty for the European pharmaceutical industry, according to France Biotech’s vice president, Alexandre Regniault.
Australia is reviewing its human tissue laws for the first time in almost 50 years, and is hoping to reduce barriers to access for scientific researchers, for instance by addressing issues with access to cell lines for developing drugs.