WELCOME TO FIERCE LIFE SCIENCES WEEKLY DIGEST After blood clot concerns beset vaccine rollouts for months, Europe’s drug regulator is investigating a new crop of potential side effects from Pfizer and AstraZeneca’s COVID shots, including reports of rare heart inflammation and nerve disorders. It’s asking for additional data, but, at the moment, said it hasn’t seen indications that the vaccines are to blame. Meanwhile, Novavax has pushed back the international review of its vaccine to July at the earliest, after quality testing issues emerged across different manufacturing sites. Those stories—plus a way to submit your nominations for this year’s class of Fierce 15—follow below. | |
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Featured Story | By Noah Higgins-Dunn The European Medicines Agency’s safety committee said on Friday that it's evaluating an assortment of potential side effects following inoculation with most leading COVID-19 vaccines, including heart inflammation, facial swelling and a rare nerve-degenerating disorder. read more |
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Top Stories Of The Week By Arlene Weintraub University of California, San Francisco scientists showed in preclinical studies that activating invariant natural killer T cells can eliminate "senescent" cells, which have been implicated in a range of age-related diseases including diabetes and osteoarthritis. A startup called Deciduous Therapeutics is working to translate the discovery into medicines for people. read more By Fraiser Kansteiner The popular heartburn med Zantac officially exited U.S. shelves last April after FDA probes into an impurity believed to cause cancer. For Sanofi and other companies battling lawsuits from the saga, the problem is far from over. read more By Annalee Armstrong Inovio is hoping to change outcomes for patients with glioblastoma using a new DNA medicine combination of INO-5401, INO-9012 and Regeneron-Sanofi’s PD-1 inhibitor Libtayo. read more By Amirah Al Idrus Novavax will not file for approval of its COVID-19 vaccine until July at the earliest, thanks to manufacturing issues related to an assay needed to show regulators that its vaccine manufacturing process is consistent across different sites. read more By Ben Adams Now in our nineteenth year, Fierce Biotech is once again seeking your nominations for the best, most exciting and innovative private biotechs. Last year, we wanted to see more COVID companies on the list, but this year there is a return to normality, and we will be happy to accept nominations from across all target areas. read more By Kevin Dunleavy With the coronavirus pandemic subsiding, Eli Lilly is set to open offices to 25% of its employees on June 1, then to all of them by July 12, CEO David Ricks announced. read more By Nick Paul Taylor Ginkgo Bioworks is set to go public through a $17.5 billion merger with a special purpose acquisition company. The deal, which involves Arie Belldegrun, will generate $2.5 billion of gross cash proceeds to support Ginkgo’s efforts to engineer cells to enable new product development. read more By Angus Liu As BioNTech makes inroads with its COVID-19 vaccine in Western countries under a partnership with Pfizer, the German biotech is bringing its work in China to the next level with a joint venture with licensing partner Fosun Pharma. The goal is to have manufacturing capacity of up to 1 billion doses a year. read more By Conor Hale After launching the commercial rollout of its first FDA-cleared device just last week, Soliton will have little time to rest on its laurels. read more By Beth Snyder Bulik Novo Nordisk is recalling about 1,500 product samples of Levemir, Tresiba, Fiasp, Novolog and Xultophy after it discovered the giant Texas winter storm—and resulting power outages—interfered with proper refrigeration. read more Resources 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: 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: BC Platforms Those wishing to unlock RWD’s true value must have access to a variety of data sources/types and the technological capabilities to use the data to uncover meaningful insights. Sponsored By: Oracle Health Sciences New research indicates an accelerated adoption of decentralized clinical trials due to COVID-19. Sponsored By: Within3 We enable virtual work — offering over-time sessions where participants are more focused, insights are more diverse and business goals are met. 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: 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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