FDA arranges Feb. 26 AdComm to discuss J&J COVID-19 vaccine EUA Sanofi flunks phase 2 Parkinson's test, culls clutch of programs U.K. government taps CureVac to target COVID-19 variants with new vaccines In Partnership: Meeting the commercialization challenge of a surging gene and cell therapy market Roche refreshingly cautious on Alzheimer's hopeful gantenerumab amid growing hype from rivals Bolt Biotherapeutics strikes a major upsized $230M IPO for next-gen cancer work 23andMe intertwines with Branson's Virgin Group to go public in $3.5B SPAC deal New study points to why CAR-T therapy may fail in some lymphoma patients Fierce Pharma Asia—WuXi-BMS plant deal; Clover-GSK COVID-19 vax pact ends; Illumina-Sequoia genomics incubator Chutes & Ladders—Merck CEO Frazier announces retirement, passing reins to CFO Davis Featured Story | By Nick Paul Taylor Johnson & Johnson has filed for emergency FDA authorization of its one-dose COVID-19 vaccine. The FDA has scheduled an advisory committee meeting to discuss the application for Feb. 26. read more |
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Top Stories By Nick Paul Taylor A phase 2 clinical trial of venglustat in Parkinson’s disease patients has failed, prompting Sanofi to stop work in the indication. Sanofi disclosed the setback alongside news that it is stopping work on a clutch of other midphase programs. read more By Amirah Al Idrus On the heels of COVID-19 pacts with Bayer and GlaxoSmithKline, CureVac is joining forces with the U.K. government to tackle the next challenge—new variants of the SARS-CoV-2 virus. If approved, any vaccines that come out of the deal will be distributed in the U.K. and its overseas and dependent territories. read more In Partnership With: AmerisourceBergen Undaunted by the challenges the COVID-19 pandemic unleashed on the world the expected surge of cell and gene therapies already in the pipeline and on the horizon will continue to materialize, and with them the complexity of riding that wave of innovation. read more By Ben Adams As Eli Lilly and Biogen stir up hope in the Alzheimer’s Disease drug space, Roche’s pharma CEO is not getting dragged into hype over its effort gantenerumab. read more By Ben Adams As the biotech class of 2021 looks to outscore the deeply impressive turn it had last year, Bolt Biotherapeutics has raked in $230 million from its upsized IPO. read more By Conor Hale Consumer DNA tester 23andMe is going public through a $3.5 billion deal spearheaded by Sir Richard Branson’s Virgin Group. read more By Angus Liu Scientists at Moffitt Cancer Center showed immune dysregulation might be to blame for lackluster responses to Gilead Sciences’ CAR-T therapy Yescarta among some patients with diffuse large B-cell lymphoma. They hope the findings will inspire new methods for improving the efficacy of CAR-T treatments. read more By Angus Liu Bristol Myers Squibb sold a Swiss plant to WuXi STA. China's Clover Biopharma will use Dynavax's adjuvant, rather than GlaxoSmithKline's, as it moves its COVID-19 vaccine into an efficacy trial. Illumina and Sequoia Capital formed a genomics incubator in Shanghai. And more. read more By Fraiser Kansteiner Ken Frazier will step down as CEO of Merck in late June, as CFO Robert Davis takes up the chief executive mantle. Lilly's cancer R&D chief is departing to pursue other opportunities. And Catamaran Bio tapped a new CEO. read more | | LabConnect is the preeminent provider of central laboratory support services for logistically and analytically complex studies - customizable to meet the unique needs of your clinical trials. We are your connection to confidence. Contact us today. |
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Resources Sponsored By: Medidata, a Dassault Systèmes company 8 parameters to optimize your “Path to Virtualization” across site- and patient-centric capabilities in this Sponsor Edition eBook. Sponsored By: LabVantage Solutions Uncover the real impact of “digital transformation” with practical advice to help you plan your own transformative journey to a harmonized digital ecosystem. Sponsored By: Acorn AI, a Medidata Company Acorn AI has developed a flexible and scalable Commercial Data Model that provides pharmaceutical companies with the data-driven insights required to respond to the industry’s ever-changing landscape. Download the whitepaper to learn how Acorn AI’s intuitive data model enables launch success and more. Sponsored By: Outer Edge Technology Criminals Are Actively Exploiting The CV-19 Pandemic To Gain Entry To Enterprise Networks. Don’t Let Your Company Become A Cybercrime Statistic -- Make These Cost-Effective IT Changes Now! Sponsored by: Cytiva It’s an exciting time to pioneer what could be a life-changing medicine. Clear the path to the clinic with pro tips and expert insights from industry leaders. Sponsored By: Polpharma Biologics Innovative cell lines and early process development are critical to generate a high producing cell lines alongside a USP strategy to meet high quality standards. Sponsored by: Cytiva A one-stop hub for Cytiva resources to support process development and manufacturing of your novel molecule Sponsored by: Catalent Autologous cell therapies have seen propelled growth since 2017, with the spotlight on the first FDA approval of a chimeric antigen receptor (CAR) T cell immunotherapy, Kymriah® (tisagenlecleucel), for the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia. Sponsored by: Premier Research Browse the latest learnings and insights from our clinical development professionals. Sponsored by: Catalent Learn about drug product process development challenges and risks, the difference between innovator and biosimilar drug product process development, and more during the drug product process development phase. Sponsored by: Catalent Get insights on key considerations for a successful tech transfer process for manufacturing a biologic drug product, including a case study on overcoming challenges in a process transfer for a sterile diluent. Sponsored by: Catalent In a BioPharma Dive industry survey, planning and forecasting were identified as top concerns for trial sponsors. In response to this need, the CSM team at Catalent has developed a methodology for identifying, evaluating, and proactively managing the inherent risks involved in clinical trial supply chain management. Sponsored by: Catalent Learn how to drive excellence within the forecasting process and utilize forecasting throughout the clinical study to better plan clinical supply budgets and project timelines. Explore how to identify potential supply-related issues before they can negatively impact your study. Virtual Clinical Trials Summit February 9-10, 2021 | Virtual Event Learn what it takes to get a drug developed and approved February 23-24, 2021 | 12 p.m. EST / 9 a.m. PST For non-scientists. Learn the science driving biopharma. February 25-26, 2021 | 9 a.m. EST / 6 a.m. PST Learn what it takes to get a drug developed and approved March 9-10, 2021 | 9 a.m. EST / 6 a.m. PST Learn the science driving biopharma. Specific for the non-scientist. March 18-19, 2021 | 12 p.m. EST / 9 a.m. PST Learn what it takes to get a drug developed and approved April 13-14, 2021 | 12 p.m. EST / 9 a.m. PST
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