| %20(1).png) | Webinar: MDR conform development of sterile Medical Devices Wednesday, September 1, 2021 | 10am ET / 7am PT Get insight on MDR requirements and their impact on the development of medical devices, relevance of adequate documentation during MDR conform development of sterile medical devices, and advantages of Contract Manufacturing as strategic partnership to fulfill MDR requirements. Register Now |
WELCOME TO FIERCE LIFE SCIENCES WEEKLY DIGEST To get its COVID-19 vaccine candidate across the FDA’s finish line, Novavax enlisted a pair of industry heavyweights, with a new CFO and VP of quality assurance. The hires come after Novavax delayed its filing to later this year, following a series of manufacturing and supply issues. Meanwhile, Translate Bio was the subject of a $3.2 billion acquisition deal this month from its financial benefactor Sanofi—but the French Big Pharma had been planning to cut back its holdings in the company as recently as April, after spending hundreds of millions on the mRNA player. What changed? Those stories, plus our other top reads of the week, follow below. | |
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Featured Story | By Fraiser Kansteiner Novavax's new SVP of quality assurance, Nasir Egal, Ph.D., hails from Sanofi, while Jim Kelly, Novavax’s new chief financial officer and treasurer, comes from Supernus Pharmaceuticals. Novavax will channel the execs’ quality and commercial know-how toward its experimental COVID-19 vaccine, which it plans to file for a U.S. emergency nod in the fourth quarter. read more |
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Top Stories Of The Week By Kyle LaHucik Sanofi was prepared to dump a quarter of its holding in Translate Bio in April—which the mRNA biotech agreed to. So how, exactly, did the French pharma end up buying Translate for $3.2 billion two weeks ago? Under-the-hood details of the deal were revealed in a Securities and Exchange Commission filing disclosed by Translate Monday. read more By Nick Paul Taylor Neuroscience has zoomed up the agenda at Eli Lilly as the combination of data on donanemab and the accelerated approval of Biogen’s Aduhelm has opened up an opportunity in Alzheimer’s disease. Lilly has responded by splitting off its late-phase neurodegeneration and pain prospects into a new business unit. read more By Noah Higgins-Dunn Belzutifan, now sold as Welireg, snared its first FDA approval on Friday for patients with a number of cancers associated with the rare disorder known as von Hippel-Lindau disease. The agency’s decision comes a month ahead of its expected decision date, and its label is broader than what some analysts expected. read more By Fraiser Kansteiner Just days before Pfizer and Medivation unveiled their merger plans in August 2016, Medivation's then-business development lead bought stock options in Incyte Corporation, the SEC says. After news of Pfizer's Medivation buyout broke, Incyte's shares jumped. read more By Andrea Park After Philips issued a recall in mid-June of nearly two dozen models of its continuous and noncontinuous ventilators, ResMed has eagerly stepped up to fill in the market gap left by Philips’ absence. read more By Noah Higgins-Dunn Roche's Genentech warned that the "unprecedented" surge in demand for its arthritis drug Actemra, used to treat severely ill COVID-19 patients, has driven a global shortage that could last for months if the pandemic continues at its current pace. read more By Beth Snyder Bulik Last week, Sesen Bio was finalizing label wording with the FDA on its bladder cancer hopeful Vicineum. This week, the CEO is explaining to investors how it will continue going forward after an FDA rejection. The unexpected FDA turn on Vicineum caught Sesen and its followers by surprise—but it’s far from alone lately. read more By Kyle LaHucik Exscientia has already found a drug candidate in its $1.2 billion partnership with Bristol Myers Squibb. The Big Pharma will pay the AI-powered drug miner $20 million for the option fee just three months after expanding their collaboration, which included a $50 million upfront payment. read more By Arlene Weintraub CAR-T treatments like Novartis’ Kymriah have proven effective in some B-cell-driven cancers, with one notable exception: chronic lymphocytic leukemia. Researchers at the University of Pennsylvania showed in a new study that inhibiting BET proteins can improve CAR-T functioning by reviving exhausted T cells. read more Resources Sponsored by: XIFIN inc. Download Frost & Sullivan’s enabling technologies best practices report to learn more about the four core functionalities required in successful precision medicine programs. Sponsored by: Patheon by Thermo Fisher Scientific Learn how a decentralized clinical trial strategy improves patient recruitment, reduces drop-out rates, and ultimately streamlines the path to the next trial phase. Sponsored by: Patheon by Thermo Fisher Scientific Learn how to build a robust packaging strategy and the key technical considerations in packaging design and operational planning to enable rapid commercialization of pharmaceuticals. Sponsored by: Patheon by Thermo Fisher Scientific Learn how regulations are changing and key considerations for commercializing cell and gene therapies without sacrificing quality. 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: 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: Catalent Hear industry experts discuss the recent advances, challenges and considerations in pediatric drug development. Real-life examples presented by the experts illustrate the impact of age-appropriate dose forms for pediatrics and highlight insights into the caregiver perspectives. 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: 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. | 
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