This week's sponsor is CMIC Group. | | Partner with Japan’s Largest CRO for your global drug development CMIC is the largest CRO in Japan, with extended services in drug development and GMP manufacturing, site management, regulatory consulting and contract sales. We have the full end to end solution to help you enter Japan market and fulfill your drug development and manufacturing needs in US, Japan and Asia. To learn more, click here. | Today's Rundown It's a case of déjà vu as Alzheon pulls IPO again Aptinyx fails phase 2 pain test, sparking stock crash Gilead’s clinical research VP moves to U.S.-China NASH startup Terns Pharma Lipocine talks up interim data from small NASH study Pfizer inks collaboration deal to use CytoReason's cell-centered models of immune system NIH’s stem cell-based AMD therapy set for first human trial Amgen's once-dismissed osteoporosis drug Evenity 'back in the game' after rosy FDA panel vote Featured Story | Thursday, January 17, 2019 Alzheimer’s drug developer Alzheon has pulled plans for a public listing on the Nasdaq for the second time in nine months. |
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| This week's sponsor is Sprout BioVentures. | | Announcing the Golden Sprout Competition High-potential start-ups are encouraged to apply for the Golden Sprout Award. Winners receive 6 months of chemistry support (2 FTEs) at no cost. Application period closes February 28, 2019. Click here for more information. | Top Stories Thursday, January 17, 2019 A phase 2 trial of Aptinyx’s NYX-2925 has missed its primary endpoint in patients with painful diabetic peripheral neuropathy. The failure wiped two-thirds off the value of Aptinyx, which went public last year with a $118 million IPO. Thursday, January 17, 2019 Gilead’s vice president of clinical research, Erin Quirk, is joining the NASH and cancer-focused Terns Pharmaceuticals as its new chief medical officer. Thursday, January 17, 2019 Lipocine has shared interim data from a small clinical trial of its NASH candidate LPCN 1144. Shares in the nanocap biotech shot up more than 100% in premarket trading before falling away somewhat as people dug deeper into the data. Thursday, January 17, 2019 Pfizer has inked a deal with CytoReason to use the Tel Aviv-based drug discovery and development company’s cell-centered models of the immune system. Wednesday, January 16, 2019 Researchers at the NIH’s National Eye Institute have developed a therapy from induced pluripotent stem cells to prevent blindness in dry age-related macular degeneration, and they have turned up positive animal data that set the stage for a human trial. Wednesday, January 16, 2019 If you thought Amgen osteoporosis candidate Evenity was down for the count, think again. After an overwhelmingly positive 18-1 vote in favor of approval from an FDA advisory panel Wednesday afternoon, the drug is “back in the game,” as Jefferies analyst Michael Yee put it in a note to clients. Enrollment Showcase | Sponsored by: Drexel University Online Drexel University’s online graduate programs in biomedicine, clinical research, drug discovery, and molecular medicine were developed with working professionals in mind, providing you with the education, practical skills, and competitive edge you need to be successful in your career. Learn more. |
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| Resources Sponsored by: Outer Edge Technology With FDA approval imminent, start-up Life Sciences company partners with an industry focused MSP to design and manage its regulated cloud-based infrastructure to speed time to market. Sponsored by: DeciBio Consulting With the liquid biopsy market maturing and >80 companies still competing with liquid biopsy offerings, it is crucial for investors to be able to cut through the noise and identify the winners. Presented by: Veeva Share your thoughts on the life sciences industry's progress in improving study execution. Presented by: Aprecia Get ahead of looming challenges in the market that include both generic products and new branded drugs. Sponsored by: Oracle Health Sciences New infographic shows trends in clinical development and the impact on randomization and trial supply management technology (RTSM). Sponsored by: Veeva Reduce the effort to create submissions and track registrations with a move to unified RIM. Watch the on-demand webinar. Sponsored by: Biotech Primer The Biopharma industry is moving at lightning speed and it can be a challenge to keep pace. Here at Biotech Primer we spend hours each week researching, writing, and editing original content for the Biotech Primer WEEKLY with one goal in mind: to help everyone better understand the latest science and technology driving today’s healthcare industry. Phacilitate Leaders World 2019 January 22-25, 2019 I Hyatt Regency, Miami 2nd Innovative Regulatory Pathways Summit January 28, 2019, 8 AM - January 29, 2019, 2:45 PM | Sheraton Pentagon City Hotel, Arlington, VA BIO CEO & Investor Conference February 11-12, 2019 | New York Marriott Marquis Asia-Pacific Compliance Training for Life Sciences Professionals March 4-7, 2019 | Singapore 2019 Bridging Clinical Research & Clinical Health Care Collaborative March 4–5, 2019 | National Academy of Sciences | Washington, D.C. BIO Asia International Conference March 5-6, 2019 | Grand Hyatt Tokyo | Tokyo, Japan Drug Development Boot Camp® 2019 November 20-21, 2019 | Boston, MA | Register and start preparing Today! |