| This week's sponsor is Rho. | | | [Webinar] Understanding New Drug Applications (NDAs)
Tuesday, August 14 | 1pm ET / 10am PT
Understand what is involved in an NDA including regulatory strategy, data integration and readiness, and electronic publishing, and get tips that can help you avoid common pitfalls in the submissions process. Register Now! |
Today's Rundown Shire’s fast-track NASH drug abruptly stopped in phase 2 Pfizer drops diabetes and cancer drugs from clinical pipeline Beijing’s CANbridge brings on Pfizer rare disease leader as CMO to help bring new drugs to China Otsuka’s guadecitabine fails phase 3 AML trial Sublimity hires new CMO as it advances UC candidate in phase 2 Active Bio and Teva’s laquinimod fails once more, now in Huntington’s disease GV-backed Verana raises $30M to mine patient registries for drug development data Lack of blockbuster candidates at Takeda? Don’t worry, Shire has it covered Featured Story | | | Tuesday, July 31, 2018 Shire has quietly cut the trial of an FDA fast-tracked fatty liver disease drug, although it’s not giving much away about what happened. |
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Top Stories Tuesday, July 31, 2018 Pfizer has culled Type 1 diabetes and cancer drugs from its early-phase pipeline. The actions affect anti-IL7R antibody PF-06342674 and third-generation, mutant-selective EGFR tyrosine kinase inhibitor PF-06747775. Tuesday, July 31, 2018 Beijing’s CANbridge Life Sciences, which develops Western drug candidates in China and Asia, brought on Pfizer’s May Orfali to be its new chief medical officer. Tuesday, July 31, 2018 Otsuka’s guadecitabine has missed its coprimary endpoints in a phase 3 acute myeloid leukemia (AML) trial. The DNA hypomethylating agent failed to beat the complete response or overall survival rates achieved in the control arm, leaving Otsuka looking to ongoing trials in other indications to save the drug. Tuesday, July 31, 2018 Ulcerative colitis specialist Sublimity Therapeutics brought on Jesse Hall, M.D., to be its new chief medical officer, as the company looks to advance the clinical development of its lead candidate into a phase 2b study. Tuesday, July 31, 2018 Active Biotech and Teva delivered more bad news from their clinical development of laquinimod, this time from a phase 2 trial in Huntington’s disease. The study did not meet its primary endpoint, comparing changes in motor skills after one year of treatment. Tuesday, July 31, 2018 Verana Health raised $30 million in a funding round to further its medical informatics platform, which uses real-world data and electronic health records from specialty-focused, regulatory-grade data sets to support the development of new drugs and devices. Tuesday, July 31, 2018 Takeda’s revenue during the April-to-June quarter was flat compared to last year. But the challenge in analysts’ eyes isn't sinking Velcade sales but a lack of up-and-coming products to buoy future revenue. Luckily, Shire has about a dozen late-stage drugs that could fill the gap. Resources Sponsored by: Veeva Industry Research: See new results from one of the industry's largest, global clinical operations surveys. Sponsored by: Medidata Accelerate Clinical Research as Study Complexity Grows Sponsored by: Veeva Ready to modernize your RIM environment? Secure buy-in with these tips. Sponsored by: Patheon, part of Thermo Fisher Scientific Biologics, orphan drugs, and precision medicine are on the rise, and that means some big changes for drug development and manufacturing companies. What should pharma companies look for when navigating this new era of small-volume manufacturing? Here are some ideas to consider when developing a new manufacturing strategy. Sponsored by: Veeva See results from the Tufts eClinical Landscape Study – CRO Report on current data management practices, goals, and challenges for contract research organizations (CROs). Sponsored by: Docusign Life science companies are experiencing a significant transformation in how they bring new products to market. Drug Approval, Manufacturing Quality & Regulation 2018 | Online The Life Science Women's Conference August 8-9, 2018 | Austin, Texas Join 200+ Service and Support Leaders at Field Service Amelia Island this August August 27-29, 2018 | Amelia Island, FL BIO Latin America 2018 September 4-5, 2018 | São Paulo, Brazil RESI HealthTech Week September 5-7, 2018 | Boston, MA 2018 Latin America Healthcare Compliance Certification Program Sao Paulo, Brazil | Sep 24-27, 2018 4th Annual Bio/Pharmaceutical Product Launch Summit September 25-26, 2018 | Cambridge, MA Drug Development Immersion September 26-27, 2018 | West Windsor, NJ FierceBiotech 3rd Drug Development Forum October 1–3, 2018 | Hilton Boston Logan Airport Hotel | Boston, MA Compliance Certification Program at Seton Hall Law October 8-11, 2018 | Newark, NJ The Advanced Biologic Development Summit at Northeastern University October 9, 2018 | Boston, MA BioImmersion: Biotech for the Non-Scientist October 16-18, 2018 | Chicago, IL 2018 BIO Investor Forum October 17-18, 2018 | Westin St. Francis, San Francisco, CA FierceBiotech Executive Summit: London October 30, 2018 | Royal Society of Medicine Drug Development Boot Camp® 2018 – Register Now! November 14-15, 2018 | Boston, MA | Register now and start your pre-Boot Camp preparation Field Service Amsterdam November 27-28, 2018 | NH Collection Amsterdam Grand Hotel Krasnapolsky | 