| This week's sponsor is Premier Research. | |  | ICH GCP guideline updates. Looking for the best insights?
The ICH Good Clinical Practice guidelines have been updated to reflect profound changes in how clinical trials run. Our white paper covers what you need to know. Premier Research. It's what we do. Best. |
Today's Rundown Featured Story | | | Monday, March 26, 2018 A phase 2 trial of Ablynx’s vobarilizumab in systemic lupus erythematosus has missed its primary endpoint. The setback tarnishes one of the drugs Sanofi is set to acquire through its $4.8 billion takeover of Ablynx. |
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Top Stories Monday, March 26, 2018 Protagonist Therapeutics has scrapped a phase 2b ulcerative colitis trial of its lead program PTG-100. The oral alpha-4-beta-7 integrin antagonist peptide performed badly enough in the first 65 patients for a data monitoring committee to rule it would be futile to continue. Monday, March 26, 2018 In Gilead’s latest round of musical chairs, its clinical director of cancer research, Henry Adewoye, M.D., has jumped ship to Compugen, where he will serve as chief medical officer. Monday, March 26, 2018 As leaders in science and business, two high-profile female CEOs have been instrumental in advancing medical breakthroughs and are champions for issues that affect women around the world. Monday, March 26, 2018 Biohaven says it has two positive phase 3 trials in hand for its oral CGRP inhibitor for migraine, setting up a filing next year, although investors seemed to be spooked by the data. Monday, March 26, 2018 A quiet immuno-oncology startup that has just began clinical tests and a rare disease biotech using Big Pharma drugs are both looking to raise funding on the U.S. IPO market. Monday, March 26, 2018 Venture capital firm Novo Holdings says it is looking to fuel more early- and late-stage biotechs. Monday, March 26, 2018 Roche’s French pharma unit has expanded its digital therapeutics pact with Voluntis. The revised deal builds on the work Roche and Voluntis have done on data-driven improvements to symptom control in breast cancer patients. Monday, March 26, 2018 Diabetes drugs such as Merck’s Januvia work by inhibiting an enzyme called DPP4, which is a factor in the disease because it interferes with a hormone that’s vital for insulin production. Researchers at Columbia University have discovered a new link between DPP4 and obesity—insight that could inspire new treatments for Type 2 diabetes. Monday, March 26, 2018 Never underestimate the power of positivity, which triumphed in the latest round of voting in FiercePharma’s drug-naming shootout. Word associations with "true," "yes" and "bright" drove victories in several of the toughest matches. Resources Sponsored by: DocuSign Life science companies are experiencing a significant transformation in how they bring new products to market. Sponsored by: Reprints Desk The competitive landscape in medical device R&D is tough. And simply investing in R&D is no guarantee for profitability. So how do you accelerate time-to-market? Sponsored by: WCG Selecting the right sites to conduct your clinical trials will determine the success or failure of meeting your enrollment goals. 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. | 
