| This week's sponsor is Premier Research. | | | Atopic Dermatitis: Where Do We Go From Here?
Improved understanding of atopic dermatitis is revealing new insights and treatment options. Get current by downloading our white paper examining these exciting and emerging therapies. Premier Research. It's what we do. Best. |
Today's Rundown Sanofi inks €3.9B Ablynx buyout to pip Novo in M&A fight FDA demands 2-year phase 3 from Aradigm in hard-hitting approval rejection Roche bags breakthrough status for autism hope balovaptan Theravance COPD drug on track for FDA decision by November Gottlieb: We need to think differently about how we regulate diagnostics ACRO to focus on regulatory changes in 2018 with Covance CEO Ratliff as new chair Featured Story | | | Monday, January 29, 2018 Sanofi has struck a €3.9 billion ($4.8 billion) deal to acquire Ablynx. The French pharma’s €45-a-share cash bid enabled it to leapfrog Novo Nordisk in the race to buy Ablynx and land its second big-ticket takeover of the month. |
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| This week's sponsor is Dell EMC. | | | [Webinar] Is Your Life Science Data "F-A-I-R"?
Tuesday, February 13 | 2pm ET / 11am PT
Is Your Life Science Data "F-A-I-R"? Join DataFrameworks & Dell EMC in this webinar to discover a new approach to create scientific data that is findable, accessible, interoperable, and reusable. Register now! |
Top Stories Monday, January 29, 2018 The FDA has told Aradigm it will need to run a two-year phase 3 trial before refiling for approval of its inhaled formulation of ciprofloxacin. That recommendation leaves Aradigm potentially needing to raise a sizable sum of money at a time when its stock is plumbing new depths. Monday, January 29, 2018 Roche has been awarded breakthrough status for a drug that has shown some signs of activity in autism spectrum disorders, according to reports. Monday, January 29, 2018 If approved, Theravance and Mylan’s nebulized COPD drug would be the first once-daily, nebulized bronchodilator for COPD. The FDA is set to return a decision by Nov. 13. Monday, January 29, 2018 Scott Gottlieb, M.D., wants the FDA to work with Congress to overhaul the regulation of diagnostics. The FDA commissioner thinks revisions are needed to give the agency authorities that are a better fit for modern diagnostics than the current 510(k) pathway. Monday, January 29, 2018 Covance CEO John Ratliff has been elected as the Association of Clinical Research Organizations’ 2018 chairman, as ensuring smooth implementation of regulatory changes in the U.S. and Europe remains the industry group’s top priority. 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: Agilent This Agilent intact protein analysis includes: 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. Presented by: Patheon Download Patheon’s whitepaper to discover two main areas where a drug developer can face significant obstacles during biologics development and how by evaluating these capabilities, it can answer the critical question of whether its in-house strategy is ready for these uncertainties. Presented by: SDC and Stiris Research What do you do when timelines are missed, data is dirty, and everyone is pointing fingers? Join this webinar to learn how to prevent, identify, and implement a successful clinical trial rescue. Sponsored by: Veeva Systems Expanding into new markets places a spotlight on inefficient processes. Sponsored by: Veeva Systems Regulatory leaders share challenges and best practices from a lack of standardization, manual processes, and fragmented systems. 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: 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. 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. 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 Approval, Manufacturing Quality & Regulation 2018 | Online TMF Operations: a Quality and Regulatory Approach March 19 - 21, 2018 | Berlin, Germany
Drug Development Boot Camp® 2018 November 14-15, 2018 | Boston, MA ICI Boston Summit 2018 March 19-21, 2018 | Boston, MA MIXiii-Biomed 2018 May 15-17, 2018 | Tel-Aviv, Israel Field Service Medical February 26-28, 2018 | Hilton La Jolla, Torrey Pines, CA | 