| 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 Featured Story | | | Thursday, August 2, 2018 Fortress Biotech used its own in-house brokerage firm, National Securities, to raise at least $240 million from thousands of individual investors to support itself and its biotech subsidiaries—employing analysts bullish on its own companies’ prospects without fully disclosing their connections to their parent, according to a monthslong investigation by Reuters. |
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Top Stories Friday, August 3, 2018 Cellectis has named Stefan Scherer, M.D., Ph.D., as its SVP of clinical development. Scherer joins the off-the-shelf CAR-T pioneer from Novartis, where he headed up U.S. oncology early development and strategy. Friday, August 3, 2018 Thomas Hughes, Ph.D., has left Zafgen to become CEO at mTORC1 startup Navitor Pharmaceuticals. Hughes helmed Zafgen through a turbulent time in which it abandoned its lead candidate after patients died in a phase 3 study. Thursday, August 2, 2018 The gene editing system CRISPR-Cas9 is promising for its potential to treat diseases caused by gene irregularities, but fears of off-target effects threaten to delay its development. New research suggests that using a different protein, Cas12a, may be the best way to address CRISPR’s shortcomings. Thursday, August 2, 2018 In this week's EuroBiotech Report, EMA sounds the alarm about its Brexit move; Cell Medica hires a CEO from Kite Pharma; ReViral raises $55 million and more. Friday, August 3, 2018 Takeda's lack of late-stage assets underscores the importance of the Shire buyout; GlaxoSmithKline is closing a Bangladesh plant as part of its emerging markets revamp; Novartis licenses out two GSK-developed cancer drugs to Shanghai-based Laekna; and more. Friday, August 3, 2018 CAR-T maker Cell Medica has named Kite’s European chief as CEO; Oncorus poached a Moderna cancer executive; and Achaogen has axed R&D and its C-suite. Those moves plus more hirings, firings and retirings throughout the industry. Resources Sponsored by: WCG Selecting the right sites is the most crucial decision you’ll make in your next clinical trial, and the single most important factor to consider in selecting a site is whether or not it can meet its enrollment goals. 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). Drug Approval, Manufacturing Quality & Regulation 2018 | Online The Life Science Women's Conference August 8-9, 2018 | Austin, Texas BIO Latin America 2018 September 4-5, 2018 | São Paulo, Brazil RESI HealthTech Week September 5-7, 2018 | Boston, MA 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 |
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