Featured Story | By Ben Adams Just two weeks after seeing a positive data readout from a small midstage test, Sanofi and GlaxoSmithKline got the signoff for a much bigger phase 3, which could lead to a full approval by the fourth quarter. read more |
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Top Stories By Amirah Al Idrus Novartis’ foray in COVID-19 therapeutics hit a snag in December, when its Mesoblast-partnered cell therapy failed to help patients with a life-threatening lung injury from COVID-19. But its second effort is gathering steam. The Big Pharma, along with Molecular Partners, is kicking off a phase 2/3 study of its prospect to see whether it can ward off severe disease and hospitalization. read more By Nick Paul Taylor Tectonic Therapeutic has appointed Peter McNamara as head of research. McNamara joins Tectonic from the Genomics Institute of the Novartis Research Foundation (GNF), where he rose to the title of head of biotherapeutics and biotechnology over a 16-year spell at the group. read more By Kyle LaHucik EFFECTOR Therapeutics thinks it can be effective in clinical trial advancement following SPAC merger with Locust Walk read more By Ben Adams Magenta Therapeutics is losing its chief medical officer and head of R&D John Davis, M.D., with his last day coming July 30. read more By Kyle LaHucik Pulmocide will bring its lead asset targeting invasive pulmonary aspergillosis into a global phase 3 registration program following an infusion of $92 million. read more By Nick Paul Taylor Esco Lifesciences has raised $200 million in a series A and crossover round co-led by Novo Holdings and Vivo Capital. The Singapore-based company will use the cash to establish a hub for cell and gene therapy tools and technologies in Boston while expanding in China and making bolt-on acquisitions. read more By Andrea Park Akili will use its new cash to help commercialize EndeavorRx, its FDA-cleared prescription video game for attention deficit hyperactivity disorder (ADHD), while developing new video game-based treatments for other acute and chronic cognitive disorders. read more Resources Sponsored by: BBK Worldwide Create a more diverse and inclusive clinical trial enrollment and engagement environment by learning the barriers to participation and the strategies to overcome them. Sponsored by: Thermo Fisher Scientific Autologous cell and gene therapy workflows involve isolating cells from an individual, engineering the cells, expanding and concentrating them, and infusing them back into the patient. Optimized automation of certain steps of the workflow may decrease hands-on time and the cost of the cell manufacturing process. Sponsored By: Veeva Learn how to develop a standards program that has your full team’s buy-in and improves the efficiency and quality of your clinical trials. Sponsored By: Veeva One top 10 pharma outlines three key steps to launching a modular content strategy to generate localized content faster. Sponsored By: Blue Matter This 77-page e-book explores 7 keys to success that any biopharma company needs to keep in mind as it enters Europe. Sponsored by: Datacubed Health The average clinical trial spends $40,000 per patient. Yet despite these high costs, most trials struggle to retain patients. Sponsored By: AmerisourceBergen Developing a quality product and getting it approved for distribution is not enough to guarantee commercial success. Sponsored By: WCG Trifecta The new standards in study training help sponsors and CROs reduce costs by 60%, cut training time by 50%, and start enrollment 55 days faster – learn more today. Sponsored By: Oracle Health Sciences New research indicates an accelerated adoption of decentralized clinical trials due to COVID-19. Sponsored by: Cytiva A one-stop hub for Cytiva resources to support process intesification Sponsored By: August Bioservices How has COVID-19 impacted CRO/CDMO customer (dis)satisfaction and outsourcing decisions for pharma and biotech companies in 2021 and beyond? Sponsored by: Cytiva A one-stop hub for Cytiva resources to support process development and manufacturing of your novel molecule Sponsored by: TAC Roche has inked a $1.8 billion, all-cash deal for GenMark Diagnostics, to acquire its molecular tests designed to screen patient samples for multiple infections simultaneously. 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. 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: 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. | 
