This week's sponsor is RAPS. | | | Today's Rundown Roche, Calico vet Hal Barron takes GSK R&D hot seat, as Vallance out Kerrisdale predicts failure for Prothena rare disease medication in short attack Gottlieb: Don’t take away FDA’s drug/device approval remit for soldiers [Sponsored] Are You Prepared to Address International Pediatric Plan Requirements? Amgen makes regenerative medicine play, backing $25M Fortuna round to move neural stem cells into the clinic Boehringer gets deeper into NASH, RNA with MiNA pact QuintilesIMS no more. Say hello to IQVIA FDA loosens rules on consumer genetic health tests Featured Story | Wednesday, November 8, 2017 Former Roche and Calico vet Hal Barron has become the new CSO and research chief at GlaxoSmithKline amid a shake-up from its new CEO Emma Walmsley. |
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| Top Stories Wednesday, November 8, 2017 Sahm Adrangi’s Kerrisdale Capital Management, known for its activist short positions, has given Elan spinoff Prothena the unwanted title of the “next big biotech blowup.” Wednesday, November 8, 2017 FDA Commissioner Scott Gottlieb has hit back at plans that could see the Pentagon take control over the approval of some experimental drugs and devices for soldiers. Monday, November 6, 2017 Did you know pediatric plans are a requirement for virtually all new medicines, not just those identified as available for children? Gain insights from Dr. Dehlinger-Kremer, chair of the EFGCP and EUCROF on this requirement. Wednesday, November 8, 2017 Amgen’s VC wing has invested in Fortuna Fix to help move autologous neural stem cells into the clinic. The $25 million series B sets regenerative medicine startup Fortuna to move candidates against Parkinson’s disease and spinal cord injury to clinical trials next year. Wednesday, November 8, 2017 Boehringer Ingelheim has entered into its second RNA therapeutics NASH deal in as many weeks. The new pact sees Boehringer commit to up to €307 million ($356 million) to work with MiNA Therapeutics on up to three targets relevant to NASH and other fibrotic liver diseases. Wednesday, November 8, 2017 About a year after QuintilesIMS was born from a megamerger between Quintiles and IMS Health, the contract research giant has decided to turn the page and rebrand as IQVIA, pronounced as “I-Q-via.” Wednesday, November 8, 2017 The FDA has cleared the way for more direct-to-consumer genetic health tests to come to market. If finalized, the approach will allow certain manufacturers to bring genetic tests to market without undergoing premarket review. This week's sponsor is PRA Health Sciences. | | Developing or reformulating a CNS Therapeutic? The Fundamentals of Human Abuse Potential (HAP) Studies: A 7-Point Checklist Download and Learn More | Resources Sponsored by: Veeva Systems Gain a complete, real-time view of quality and streamline operations. Incorporate partners into processes for critical oversight and 30% greater efficiency, and transform cross-functional processes like change control. Sponsored by: Reprints Desk SO CLOSE AND YET SO FAR. Is that how many documents seem to you? Getting what you want—when, where, and how you want it—can be a real pain. That’s why we created this concise guide to getting around the obstacles that stand between you and the information your organization needs. Download the whitepaper to learn more. Presented by: DSM Biomedical Discover DSM's Dyneema Purity® membrane, an effective and efficient material to construct stent grafts used in minimally invasive surgeries to treat both cardiovascular and peripheral arterial diseases. Sponsored by: ePharmaSolutions As clinical trials become more complex, safety document distribution to investigative sites has reached the point that demands a solution. Sponsored by: Ashfield Healthcare Join this webinar to discover tested and proven solutions to manage vacancies. Presented by Tyler Cowan, VP, Client Solutions, Ashfield US, you’ll learn how to maintain and build momentum in field sales despite turnover. Sponsored by: Veeva CROs are leading an industry wide shift to modernize clinical systems and clinical trial processes. Presented By: Charles River Join us as we discuss how Charles River Celsis® helped Labor L+S AG validate a 7-day membrane filtration sterility test using existing protocols. Presented By: Catalent Learn how Catalent Biologics is paving the way for flexible biologics development and manufacturing through advanced technologies and fully integrated multi-product facility. Presented By: Catalent Download the eBook to get articles from various Elsevier journals highlighting developments in ADC technology. Presented By: Catalent Learn how cell development and process scale-up can be optimized for antibodies requiring additional processing. Sponsored By: RTI Health Solutions In this webinar, we will introduce the rapidly-evolving within-subject clinical trial (WSCT) methods for early phase evidence generation that require fewer people, less time, and usually less funding than traditional early phase methods. Drug Development Primer November 9, 2017 | San Diego, CA BioBasics: Biotech for the Non-Scientist November 30-December 1, 2017 | Boston, MA CBI’s Commercial Data Insights 2017 November 28-29, 2017 | Philadelphia, PA Drug Development Boot Camp® 2017 November 15-16, 2017 | Boston, MA FierceBiotech Executive Breakfast: Get Good Science and the Money will Follow January 9, 2018 | San Francisco, CA Register Today – ISPE Biopharmaceutical Manufacturing Conference December 4th-6th, 2017 | San Francisco, CA |