This week's sponsor is RAPS. | | | Today's Rundown Sage soars as postpartum depression phase 3 trials hit goals Otonomy’s renaissance starts as Ménière’s disease drug clears trial Sanofi pays $40M, commits $765M more for preclinical MS drug [Sponsored] Are You Prepared to Address International Pediatric Plan Requirements? After asthma success, AstraZeneca and Amgen’s tezepelumab misses in atopic dermatitis Chasing Alexion, Apellis hits the start button for $150M IPO Editas backer Partners taps Lilly to help raise $171M fund Improving cancer immunotherapy by harnessing new technology NIH recruits Fitbit for Precision Medicine Initiative program Featured Story | Thursday, November 9, 2017 Sage Therapeutics’ brexanolone has cleared the bar of efficacy in two phase 3 trials in women with postpartum depression. The trials linked the intravenous formulation of allopregnanolone to statistically significant improvements on a depression scale, teeing Sage up to file for approval next year and sending its stock up 44%. |
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| Top Stories Thursday, November 9, 2017 Just weeks after a phase 3 setback caused it to slash staff and R&D programs, Otonomy has bounced back with a positive late-stage trial for its lead candidate Otividex in Ménière’s disease. Thursday, November 9, 2017 Sanofi has committed up to $805 million to license multiple sclerosis drug PRN2246 from Principia Biopharma. The French Big Pharma is paying $40 million upfront to pick up the preclinical asset, with $765 million more to follow if it passes all the milestones that await. 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. Thursday, November 9, 2017 AstraZeneca and Amgen’s tezepelumab missed the primary endpoint in a phase 2a atopic dermatitis trial, raising doubts about the prospects of the thymic stromal lymphopoietin antagonist making a mark in a congested field featuring Sanofi, Pfizer and Novartis. Thursday, November 9, 2017 Flush with recent clinical trial wins, Apellis has moved quickly ahead with an initial public offering that it hopes will raise $150 million and give it the reserves needed to take its lead complement drug through the next phases of clinical development. Thursday, November 9, 2017 Partners HealthCare System has grown its early-stage fund into a $171 million investment vehicle. The Boston-based hospital network achieved the jump in scale by turning to outside backers including Eli Lilly, which collectively pumped $66 million into the fund. Wednesday, November 8, 2017 Checkpoint-inhibiting drugs like Merck’s Keytruda and Bristol-Myers Squibb’s Opdivo have transformed the treatment of some cancers, but they don't work for some patients, and for others they cause dangerous autoimmune responses. Two new ideas for improving these drugs were proposed this week. Wednesday, November 8, 2017 The National Institutes of Health has tapped Fitbit to provide 10,000 devices for the All of Us research program, which seeks to collect health data from more than 1 million people as part of the Precision Medicine Initiative. 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. 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: 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. 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 |