Merck taps Xeris for ready-to-use versions of antibody products Novartis-backed Credence taps Phillips-Medisize to step up production drug delivery system FDA greenlights Genentech's eye implant for macular degeneration. Will it be a tough sell? AmMax, targeting a Daiichi market, posts data on delivery of rare tumor drug Ligand licenses prodrug tech to oral COVID-19 antiviral project Top 10 drug launch disasters Featured Story By Nick Paul Taylor Merck has tapped Xeris Pharmaceuticals to help reformulate some of its drugs. The deal gives Merck a chance to license a Xeris technology to develop ultra-high concentration, ready-to-use formulations of certain monoclonal antibodies. read more |
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| | Webinar: Clinical Adjudication Survey Results Revealed Tuesday, November 2 | 1pm ET / 10am PT In a recent survey, 89% of clinical adjudication users agreed clinical adjudication provides value to clinical trials. Join two Bioclinica experts for a discussion of these and other survey results to understand how they could impact your studies. Register Now. | Top Stories By Nick Paul Taylor Credence MedSystems has hit upon a way to scale up production of its drug delivery system. Weeks after disclosing $40 million from investors including Novartis, Credence has unveiled a partnership with Phillips-Medisize to step up from a clinical line to large-scale manufacturing. read more By Kevin Dunleavy The FDA has approved Genentech’s Susvimo, a port delivery system with Roche’s ranibizumab in patients with wet age-related macular degeneration. Now the trick could be to get patients to accept an implant the size of a grain of rice placed under the upper eyelid that delivers doses of Lucentis and is refilled every six months. read more By Nick Paul Taylor AmMax Bio's attempt to muscle in on a market monopolized by Daiichi Sankyo has advanced, with the biotech posting midphase data on the effect of injecting an antibody into the joints of patients with rare tumors. read more By Nick Paul Taylor Ligand Pharmaceuticals wants another piece of the COVID-19 pie. Having been one of the companies behind Gilead’s Veklury, Ligand has positioned itself to support an oral COVID-19 antiviral through a deal with China Resources Double-Crane Pharmaceutical (CRDC). read more By Angus Liu An estimated 40% of drugs approved between 2004 and 2016 underperformed, according to Wall Street’s prelaunch sales forecasts. That's a lousy track record, given that a strong launch is critical to a drug's success. Here, we list 10 drug launches from the past five years that suffered the most noteworthy failures. read more Resources Sponsored by: Thermo Fisher Scientific Learn how to develop a high-performing supply chain for cGMP chemicals used throughout your biologics workflow. Download the free whitepaper from Thermo Fisher Scientific Sponsored by: Medable, Inc. Find out how to improve clinical protocol adherence, and thus patient outcomes, by 15%+ with Medable’s latest White Paper. Sponsored By: Trial Interactive Check out the eTMF Implementation Quick Guide to see a checklist TMF experts developed to help you reduce risks, maintain compliance, and establish effective processes in your eTMF. This whitepaper addresses where AI can make the biggest impact in clinical trials. Sponsored by: Thermo Fisher Scientific Looking to accelerate your biotech company, but not sure where to start? Sponsored by: Oracle Health Sciences New research indicates an accelerated adoption of decentralized clinical trials due to COVID-19. Sponsored by: LabVantage Solutions Shift from data collection to data science. Add advanced analytics to your lab informatics platform to yield valuable, action-ready insights from LIMS and other data. Sponsored by: Thermo Fisher Scientific Integrate supply chain simulation into your early clinical trial planning to minimize risk in an uncertain supply chain environment, improve supply chain outcomes, and help streamline time-to-market for innovative therapies. Sponsored by: WCG Every biopharma sponsor faces the challenge of initiating, running and closing trials on time, but oncology studies pose several unique hurdles. Sponsored by: Box Read Get to Know Cloud Content Management for Life Sciences and learn how to eliminate silos across all workflows, from R&D to commercialization. Sponsored By: Remarque Systems Remarque Systems consolidates data, then layers on visualization and automated metrics to generate consistent, actionable data insights in real-time. Click here for more info. Virtual European Healthcare Compliance Certificate Program January 24-28, 2022 Fierce Biotech Cell & Gene Therapy October 19, 2021 | Virtual Event TMF Summit October 25-27, 2021 | New Orleans, LA Fierce Health Payer Summit October 26, 2021 | Virtual Event Diversity, Equity, & Inclusion Summit November 9–10, 2021 | Virtual Event Learn impact of pricing, competitive assessment, epidemiology November 17-18, 2021 | Live & Online Drug Development Boot Camp® 2021 Onsite and VIRTUAL in real time November 17-18, 2021 | Register now! Pre-Boot Camp preparation is now available. Learn how therapeutics are successfully launched and commercialized December 1-2, 2021 | Live & Online New Product Planning Summit December 1-2, 2021 | Boston, MA Launch Readiness for Medical Affairs & Communications Teams December 1-2, 2021 | Boston, MA Virtual Clinical Trials Summit December 6-7, 2021 | Philadelphia, PA Fierce JPM Week January 11, 2022 | San Francisco, CA & January 18-20, 2022 | Virtual Event Fierce Pharma Drug Safety Summit February 2022 | Location TBD |