| This week's sponsor is Premier Research. | | | 7 Things to Watch When Recruiting for an Opioid Trial
Recruiting for an opioid trial? Consider seven key factors, such as avoiding drug abuse and diversion and minimizing screen failures. Find the details here. Premier Research. It's what we do. Best. |
Today's Rundown Roller-coaster ride for Solid Bio ahead of downsized IPO AstraZeneca’s triple-hit COPD inhaler meets goals in phase 3, setting up scrap with GlaxoSmithKline Biopharma veterans go in on oncology company that will tackle treatment gaps Editas, Adverum extend CRISPR ocular delivery alliance Biogen’s MS drug Tecfidera could make cancer-killing viruses more potent: study EuroBiotech Report—Ablynx-Novo, Heptares CSO departs, Allergan eyes KaNDy, Synpromics-UCL and CRISPR FiercePharmaAsia—Takeda's Alzheimer’s flop, Shanghai Pharma’s U.S. plan, NextCODE talk Chutes & Ladders—NICE director joins U.K. pharma lobby group ABPI as CSO Featured Story | | | Friday, January 26, 2018 Solid Biosciences’ plans for an IPO looked in disarray after it revealed that the FDA had placed a clinical hold on its Duchenne muscular dystrophy gene therapy candidate yesterday. But it pressed on—with a cut-price offering for an upsized stake. |
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Top Stories Friday, January 26, 2018 AstraZeneca’s triple-combination therapy has outperformed Symbicort and other two-drug inhalers in a phase 3 COPD trial. The trial’s success against eight out of nine lung function primary endpoints positions AstraZeneca to start filing for approval in the second half of the year. Friday, January 26, 2018 Partner Therapeutics, which will focus on developing and commercializing approved and late-stage therapies, plans to build its portfolio by acquiring promising programs. Friday, January 26, 2018 Editas Medicine has extended its CRISPR gene editing delivery pact with Adverum Biotechnologies. The amended agreement gives Editas until the end of September to exercise its option on the first of five ocular indications covered by the contract. Thursday, January 25, 2018 Cancer-killing viruses, also called “oncolytic” viruses, made their entry into oncology practices in 2015 but have found limited success so far. Combining oncolytic viruses with the MS drug Tecfidera could be an effective way to kill a range of cancers, including renal carcinoma, Canadian researchers discovered. Thursday, January 25, 2018 In this week's EuroBiotech Report, Ablynx backer talks Novo deal, Heptares CSO leaves for Merck, Allergan eyes KaNDy and more. Friday, January 26, 2018 Takeda and partner Zinfandel cancelled testing of Actos as a potential Alzheimer’s therapy; Shanghai Pharma will open an R&D site in San Diego later this year; WuXi NextCODE looks to significantly grow its B2C business in China; plus more need-to-know news from Asia's pharma industry. Friday, January 26, 2018 NICE's executive director of the Centre for Health Technology Evaluation left for ABPI; Heptares co-founder Fiona Marshall will lead Merck’s new London research center; Sanofi promoted Dominique Carouge to head of business transformation; plus more hirings, firings and retirings throughout the industry. | This week's sponsor is IQVIA. | | | Discover a new path to your success via Human Data Science. IMS Health and Quintiles are now IQVIA™ – created to advance your pursuits of human science by unleashing the power of data science and human ingenuity. Join the journey today. Learn More. |
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 | 