This week's sponsor is Precision Oncology. | | Optimize registration success: what you need to know. Novel drug applications with biomarkers achieve 25.9% greater probability of approval than applications without. Learn the biomarker difference and 5 other key strategies. Get the free Oncology Brief | Top Stories Friday, November 11, 2016 GlaxoSmithKline CEO Andrew Witty has said moving the European Medicines Agency from London will cause “tremendous disruption.” Witty is worried moving the EMA and its 900 staff from London to another European city post-Brexit will cause upheaval that affects the smooth running of the regulatory machinery. Friday, November 11, 2016 A combination of lower corporate taxes, a sense that deregulation for meds is coming and pricing issues will be dropped, bumped-up stocks and an influx of foreign cash will combine to create a perfect storm for a major biotech M&A spree, according to analysis from Reuters. Friday, November 11, 2016 Bristol-Myers Squibb has teamed up with Johns Hopkins University to research why patients respond and develop resistance to its PD-1 drug Opdivo. The five-year project will look at the tumor microenvironment, the microbiome and other factors in a bid to better understand what happens when a patient receives Opdivo in isolation or in combination with other immunotherapies. Thursday, November 10, 2016 Gilead Sciences, whose hepatitis C dynasty has been slipping, has won approval for its next-gen hepatitis B treatment. Friday, November 11, 2016 Intuity Medical has raised $40 million to commercialize its diabetes blood glucose monitoring system. The round marks the long-delayed start of the next phase of Intuity’s evolution, which spent years trying to secure FDA clearance for its device before belatedly getting the green light in April. Thursday, November 10, 2016 Innate posts Opdivo combination data, Celyad shares a look at CAR-T results, Evotec inks a University of Oxford pact and more. Thursday, November 10, 2016 Teva promotes David Stark to chief legal officer amid DOJ's investigation of price fixing, Terrance Coughlin was named EVP and COO of Endo, and Neon Therapeutics recruits former Eli Lilly vet Dr. Richard Gaynor as new CMO. Plus more hirings, firings and retirings throughout the industry. This week's sponsor is Catalent. | | eBook | Healthy Aging: Improved Dose Forms for Aging Population As healthy aging becomes a bigger concern in the U.S., manufacturing companies are finding a new opportunities to serve this audience as they turn increasingly to OTC treatments. Download this eBook to learn how a successful partnership between OTC brands and manufacturing companies can improve health outcomes for the growing population of empowered seniors. | | PTC Therapeutics was up nearly 90% premarket on the CHMP's decision to renew its marketing app for DMD med Translarna. Release Meanwhile, Europe has also seen nine medicines recommended for approval by the CHMP, including three biosimilars. Statement After a series of setbacks, nanocap Mirna Therapeutics says it will discontinue development of its cancer microRNA med MRX34 and suspend its pipeline R&D programs. Statement | |
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