A new Cancer Moonshot collaboration of NIH with 11 biopharmaceutical companies will undertake to identify and validate biomarkers to advance immunotherapies as its first order of business, the agency announced.…
The FDA will agree to meet to discuss the ANDA deficiencies cited in a complete response letter to a sponsor only if the sponsor lists the questions it wants to…
An FDA advisory committee voted 10-0 in favor of the efficacy of a drug candidate for treatment of glaucoma and ocular hypertension Friday. Source: Drug Industry Daily
The FDA updated several ICH guidance documents to reflect Canada’s adoption of interchangeable chapters from the U.S., European and Japanese pharmacopeias. Source: International Pharmaceutical Regulatory Monitor
The European Medicines Agency has begun to adopt a new addendum to the ICH’s 1998 clinical trial statistics guideline, as well as a revision to the 23-year-old ICH guideline on…
The European Medicines Agency revised its 2009 advice to sponsors seeking evaluations of products intended exclusively for markets outside the EU. Source: International Pharmaceutical Regulatory Monitor
The European Medicines Agency said it may become more difficult for UK firms to have GMP non-compliance statements lifted following Brexit. Source: International Pharmaceutical Regulatory Monitor
<IMG SRC"http://enewsletters.biospace.com/images/news/biospace-news-815x430-national-institutes-of-health.jpg" NAME"NIH Hooks Up With 11 Top Biopharmas for $215 Million Cancer Moonshot Deal" ALT"NIH Hooks Up With 11 Top Biopharmas for $215 Million Cancer Moonshot Deal"October 13, 2017By…
HOBOKEN, N.J.--(BUSINESS WIRE)--John Wiley and Sons, Inc. (NYSE: JWA) (NYSE: JWB), a global research and learning company, today announced that Ella Balagula has been named Wileys new Executive Vice President…
<IMG SRC"http://enewsletters.biospace.com/images/news/biospace-news-815x450-fda.jpg" NAME"Spark Therapeutics Jumps as FDA Panel Unanimously Backs Breakthrough Gene Therapy" ALT"Spark Therapeutics Jumps as FDA Panel Unanimously Backs Breakthrough Gene Therapy"October 13, 2017By Mark Terry, BioSpace... Source:…