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Today's Rundown CRISPR biotech Intellia promotes R&D head to CEO post Regeneron pairs PD-1 latecomer with ISA’s HPV immunotherapy Aptinyx bags $70M to fund multidrug CNS trial strategy [Sponsored] Addressing Placebo Response, Therapeutic Misconceptions and Expectations Alnylam follows up FDA filing with EMA submission for patisiran [Sponsored] Managing Demand Uncertainty in Biologics Production Boehringer nets option on Autifony schizophrenia drug Genoptix buys sinking cancer test firm Rosetta for $10M Anti-opioid vaccine could offer bridge to overcoming addiction Featured Story | | | Monday, December 18, 2017 Intellia Therapeutics has named John Leonard, M.D., as its new president and chief as former leader and founder Nessan Bermingham, Ph.D., walks away into a venture capitalist role. |
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Top Stories Monday, December 18, 2017 Regeneron and Sanofi’s PD-1 candidate cemiplimab will be tested alongside a human papillomavirus (HPV) targeting drug from Dutch biotech ISA Pharma as they play catch-up in the checkpoint inhibitor category. Monday, December 18, 2017 Aptinyx has raised $70 million. The series B equips the biotech, which spun out of Naurex following its takeover by Allergan, to advance three drugs against neurologic disorders deeper into the clinic. Monday, December 18, 2017 Randomized, placebo-controlled clinical trials are the most complex step in the development of new drugs. A contributor to trial failure is the increased rate of placebo response, which is now historically high. How can these trends be reversed? Monday, December 18, 2017 Alnylam and Sanofi Genzyme are on a roll after submitting patisiran for FDA approval—it just filed for EMA approval and is looking to other markets, including Japan and Brazil, next. Monday, December 18, 2017 When a biologics company prepares to launch a new product, it must forecast the capacity it will need. Learn how to mitigate risks by developing a manufacturing strategy that will accommodate a forecast range and allow you to adapt as better data becomes available. Monday, December 18, 2017 Boehringer is paying €25 million ($29 million) up front and committing to up to €600 million more to land an option on Autifony Therapeutics’ schizophrenia drug and associated platform. The deal gives Boehringer the chance to purchase a Kv3.1/3.2 positive modulator platform and the phase 1b schizophrenia drug it spawned. Monday, December 18, 2017 Genoptix is paying $10 million in cash to buy Rosetta Genomics. The onetime cancer diagnostics pioneer settled for a takeout offer below its share price, resulting in its stock sliding once news of the deal emerged. Monday, December 18, 2017 Scientists at the military’s Walter Reed Army Institute of Research announced that they’ve developed a heroin vaccine that can block the euphoric effects of opioids in the brain—and do so without interfering with other therapies used to treat addiction. Resources 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: Seton Hall Don’t miss this educational program trusted by multi-national companies as part of their employee’s compliance training. Explore legal, regulatory and ethical issues faced by pharmaceutical, biotech and medical device manufacturers operating in the Asia-Pacific region. Visit event page for session topics. Sponsored by: WCG Selecting the right sites to conduct your clinical trials will determine the success or failure of meeting your enrollment goals. Sponsored by: Deloitte Sourcing research externally seems to be the preferred path for biopharma companies to strengthen their R&D pipeline. Sponsored by: Veeva Systems Read this guide if you’re a global life sciences company - conducting clinical trials across several countries, or manufacturing and distributing products in multiple regions - to learn five steps to align and improve quality oversight, as well as avoid common mistakes in harmonization initiatives. Sponsored by: Veeva Systems Read Deloitte Consulting's whitepaper on the value of a holistic RIM capability, covering the potential cost savings and revenue gains from doing RIM right. Presented By: Covance Global clinical trials are the trend and gaining in popularity, but running a global trial is not a straightforward process. This white paper explores some of the challenges associated with global clinical trials and considerations for ensuring that the collected data comply with the trial's overall objectives. 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. 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. 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. FierceBiotech Executive Breakfast: Get Good Science and the Money will Follow January 9, 2018 | San Francisco, CA BIO CEO & Investor Conference February 12-13, 2018 | New York, New York | 