This week's sponsor is RAPS. | | | Today's Rundown Roivant CEO: Yes, we failed in Alzheimer’s, but we’re not giving up Bristol-Myers posts early checkpoint combination data on fast-advancing rival to Incyte’s IDO1 inhibitor After months of searching, Immunomedics lines up Celgene vet Pehl as its new CEO [Sponsored] Are You Prepared to Address International Pediatric Plan Requirements? Ex-Shire R&D chief takes charge of immuno-oncology firm Roche pens septic shock diagnostic pact Persistence pays off for Dynavax as twice-rejected hepatitis B vaccine wins FDA nod EuroBiotech Report—NousCom round, Cellectis hold lifted, Sanofi MS deal, AstraZeneca trial fail and BI NASH pact FiercePharmaAsia—Teva’s China JV? Lupin plants’ roadblock, EOC’s $32M series B Chutes & Ladders—GlaxoSmithKline CSO Vallance out, Hal Barron in Featured Story | Friday, November 10, 2017 Bucking a growing and depressing trend in biotech, Roivant’s Vivek Ramaswamy is not spinning his company’s Alzheimer’s disease failure in September. |
|
| Top Stories Friday, November 10, 2017 Bristol-Myers Squibb has posted interim data on its IDO1 inhibitor in combination with Opdivo. The early look at data in heavily pretreated bladder cancer patients suggests the cocktail can hold its own against a combination of rival drugs from Incyte and Merck. Friday, November 10, 2017 Immunomedics has drawn a firm line under the disruption among its top management in recent months by hiring biotech veteran Michael Pehl—formerly of Celgene—as its CEO. 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. Friday, November 10, 2017 Northern Biologics has named former Shire R&D chief Phil Vickers, Ph.D., as CEO. The appointment puts Vickers in charge of the Celgene-partnered biotech as its lead immuno-oncology asset closes in on the start of clinical testing. Friday, November 10, 2017 Roche Diagnostics has entered into a collaboration with a biotech startup. The deal will see Roche work with Inotrem to develop an assay for measuring a biomarker correlated to negative outcomes in septic shock patients. Thursday, November 9, 2017 Dynavax completed the long road to approval for its hepatitis B vaccine Heplisav-B on Thursday, securing an FDA nod after two previous rejections. Now, the company is set to challenge GlaxoSmithKline's Engerix-B and transition into a commercial biotech. Thursday, November 9, 2017 In this week's EuroBiotech Report, NousCom raises €42 million, FDA lifts Cellectis clinical hold, Sanofi strikes $805 million deal and more. Friday, November 10, 2017 Teva is reportedly looking to form a Chinese joint venture, two of Lupin's plants were hit with a combined FDA warning letter, China's EOC Pharma has raised $32 million to help bring several cancer drugs to market, and more. Friday, November 10, 2017 Patrick Vallance is leaving to become the U.K. government's chief scientific adviser and Hal Barron is taking his place as GlaxoSmithKline CSO; Biogen poached Merck executive Guindo to lead global marketing; former Celgene hematology & oncology head Pehl to helm Immunomedics; plus more hirings, firings and retirings throughout the industry. 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 See the results from one of the largest, most in-depth surveys of clinical data management professionals on data management practices, performance, and challenges. 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 December 5, 2017 | 2pm EST / 11am PST | Sponsored By Ashfield Healthcare Join this webinar to learn methods that maintain and build sales momentum 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 |