Today's Rundown With positive phase 3, Intercept to file NASH drug for approval while Inventiva faces a setback End of the line looms for Aradigm as it files for bankruptcy Pfizer and Lilly’s NGF painkiller moves forward, meeting phase 3 endpoints in lower back pain [Sponsored] Preventing Unnecessary Exposure to Opioids After Surgery Realm set to offload assets, leave London following failures Arix reappoints CEO 5 months after starting hunt for replacement CRISPR corrects DMD in mice for a year in Sarepta-supported study Novartis’ AveXis doubles down with $115M manufacturing investment Featured Story | | | Tuesday, February 19, 2019 In a pivotal phase 3 study, Intercept Pharmaceuticals' obeticholic acid met its primary endpoint of improving liver fibrosis without any worsening of nonalcoholic steatohepatitis (NASH) after 18 months of treatment. It plans to file for approval in the U.S. and Europe by the end of the year. |
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| This week's sponsor is Covance. | | | Optimizing Protocol Design and Patient Enrollment Case Study:
Learn how Covance guided an emerging pharmaceutical company who was uncertain about how to balance the selection of the right patients for their trial endpoints with the ability to achieve rapid patient recruiting. Covance leveraged their extensive and proprietary data sources to make recommendations that helped the sponsor substantially reduce the risk of high screen failure rates. Download the Case Study now. |
Top Stories Tuesday, February 19, 2019 Aradigm’s bid to get an inhaled antibiotic to market seems at an end, with its assets up for sale and the jobs of two primary executives terminated. Tuesday, February 19, 2019 Eli Lilly & Co. and Pfizer’s nonopioid nerve growth factor inhibitor tanezumab beat out placebo in a phase 3 study of patients with chronic lower back pain who had previously seen inadequate relief from at least three different classes of painkillers. Monday, February 18, 2019 The opioid crisis continues to dominate the headlines and while many solutions are being discussed, prevention is often overlooked. Reducing exposure to opioids after surgery through better pain management options can make an impact. Tuesday, February 19, 2019 Realm Therapeutics is set to sell assets and drop its London stock listing. The actions are part of the biotech’s ongoing efforts to seek a way out of its R&D-triggered troubles. Tuesday, February 19, 2019 Arix Bioscience’s five-month search for a CEO has ended with it reappointing the person who vacated the role at the start of the process. Joe Anderson stepped down as CEO in September to take up the chief investment officer position but now finds himself back in charge of the company. Monday, February 18, 2019 A Duke lab at the center of a research pact with Sarepta is reporting promising results from a trial of CRISPR gene editing in mouse models of DMD. But the treatment has produced some off-target effects, which the researchers plan to investigate further in future studies. Tuesday, February 19, 2019 AveXis, which Novartis acquired last year for $8.7 billion, announced it will invest another $60 million and hire another 200 workers for the site it is building in Durham, North Carolina. That is on top of the $55 million it pledged to invest in the plant last year when it first projected hiring 200 employees. Resources Sponsored by: Blue Matter White paper outlining the key types of cell-based immunotherapies in oncology, as well as the development and commercial outlook for each. Sponsored by: AlphaSense It’s never been more challenging to stay on top of trends and innovation shaping the future of healthcare. Discover how AI can help competitive intelligence teams achieve more proactive strategies. Presented by: SDC If commonly used statistical phrases like two-sample t-test, difference in proportions, or hazard ratio intimidate you, join this webinar for an introduction to statistical analyses in clinical trials. Sponsored by: Patheon, part of Thermo Fisher Scientific When a biologics company prepares to launch a new product, it must forecast the manufacturing capacity it will need, factoring in its estimate of the size of future sales, the timing of the launch, the dosage of the product, its strategy for building its market and a host of other variables. Sponsored by: Oracle Health Sciences 92% of survey respondents make changes to their RTSM/IRT systems due to study changes. See what else puts a strain on their clinical trials. Download the Research Whitepaper. Sponsored by: Patheon, part of Thermo Fisher Scientific Download this whitepaper to learn more. Sponsored by: The Kinetix Group Explore how the pharma industry can adapt its approach to the changing healthcare marketplace in the era of the Quadruple Aim Sponsored by: Cofactor Genomics Learn how Health Expression Models provide increased sensitivity, specificity, and accuracy for characterizing immune response in solid tumor specimens. Sponsored by: BioAnalytix, Inc. This whitepaper reviews fundamental aspects of HCPs that pertain to biologic drug development and presents current and emerging approaches to HCP analysis. Sponsored by: Veradigm Clinical trials take too long and cost too much—here's what needs to change. Sponsored by: Reprints Desk, Inc. Go from Search to Full-Text Scientific Papers in a Single Click! Sponsored by: Blue Latitude Health This white paper consists of original data and expert interviews. Download it today for exclusive tools, tips and analysis on achieving launch excellence in challenging pharma markets. 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. Presented by: Veeva Share your thoughts on the life sciences industry's progress in improving study execution. 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. BIO Asia International Conference March 5-6, 2019 | Grand Hyatt Tokyo | Tokyo, Japan PEGS: The Essential Protein Engineering Summit April 8 – 12, 2019 | Boston, MA Middle East Life Sciences Compliance Training April 29, 2019 – May 2, 2019 | Dubai U.A.E. Drug Development Boot Camp® 2019 November 20-21, 2019 | Boston, MA | Register and start preparing Today! | 