WELCOME TO FIERCE LIFE SCIENCES WEEKLY DIGEST As coronavirus mutations emerge across the globe, concerns rise over the future effectiveness of vaccines, treatments and screening tests. New data from Novavax showed its shot still performed well against the B.1.1.7 variant first found in the U.K., but less so against South Africa’s B.1.351. Nevertheless, global production moves forward, with Novartis offering up its manufacturing lines to Pfizer and BioNTech, and analysts predict blockbuster sales for each of the top five vaccine programs as the world waits in line. Those stories, plus our top reads of the past week, follow below. | |
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Featured Story | By Nick Paul Taylor Novavax’s COVID-19 vaccine has achieved 89.3% efficacy in a phase 3 clinical trial that enrolled subjects exposed to the B.1.1.7 variant found in the U.K. However, the vaccine performed far worse in a smaller phase 2b that pitted it against another variant first identified in South Africa, intensifying concerns that updated prophylactics will be needed to protect against the evolving virus. read more |
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Top Stories Of The Week By Eric Sagonowsky Only a day after Novartis said it was looking at offering its manufacturing network to the global COVID-19 fight, the company is joining forces with Pfizer and BioNTech to help produce mRNA vaccines. It's the latest example of an unlikely Big Pharma partnership spurred by the urgent need to defeat the pandemic. read more By Eric Sagonowsky With Novavax and Johnson & Johnson data now in hand, the world has efficacy numbers on at least five COVID-19 vaccines. That's plenty for analysts to parse—and they're busy doing not only that, but also sizing up potential sales. The upshot? Blockbuster sales to go around, but some will capture a lot more than others. read more By Ben Adams As Biogen hopes and prays for a (now delayed) FDA approval of its controversial Alzheimer’s disease hopeful aducanumab, a key, closely watched pipeline asset has failed and been tossed out. read more By Angus Liu A manufacturing shortfall likely cost Bristol Myers Squibb the chance of an FDA approval for CAR-T therapy liso-cel by the end of 2020—and sent a potential $9-apiece Celgene deal sweetener into the trash can. Investors looking for details of the expensive misstep now have the answers in an FDA Form 483. read more By Arlene Weintraub Two COVID-19 vaccine candidates built from gene therapy technology elicited strong immune responses in mouse and nonhuman primate models. The Mass General scientists who developed the vaccines believe their ability to be stored at room temperature and to be administered in just one dose could make them popular choices for developing countries. read more By Angus Liu CRISPR-Cas9 has made waves in the biomedical world as a revolutionary gene editing tool, but it has its limitations. A team from the University of Illinois at Urbana-Champaign showed that an alternate technology, TALEN, is up to five times more efficient than CRISPR-Cas9 in highly compact forms of DNA. read more By Angus Liu Bristol Myers Squibb just broke into previously untreated non-small cell lung cancer less than a year ago with an FDA go-ahead in PD-L1-positive patients for the dual checkpoint inhibitor regimen of Opdivo and Yervoy. But rival Merck & Co. is already casting doubt on its place in the lucrative market. read more By Beth Snyder Bulik Amgen is cutting about 500 jobs, and its U.S. sales teams are bearing the brunt of it. The California-based drugmaker confirmed Wednesday that it is shrinking its workforce, "primarily in the U.S. sales force," as it pivots to upcoming drug launches and adopts pandemic-time digital marketing tools for the long run. read more By Conor Hale The FDA approved Medtronic’s DiamondTemp irrigated ablation catheter, designed to treat patients with recurrent atrial fibrillation that has not responded to drug therapies. read more 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: 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: 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 proven strategies for a successful product launch, including cross-functional team collaboration, risk management and using the right project management tools. Sponsored by: Catalent Learn about a real-world example of how clinical supply management expertise was applied to overcome inventory challenges for a complex, global study. Sponsored by: Catalent Whether a study is simple or highly complex, forecasting and simulation reports serve as data driven communication tools to help minimize risks and keep the study on track. Learn more about forecasting solutions for informed decision making and supporting contingency planning for clinical study. | 
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