WELCOME TO FIERCE LIFE SCIENCES WEEKLY DIGEST With COVID-19 vaccines in the international spotlight, so too are their makers. With Moderna becoming a household name, the company has since spent more than $1 million on security for CEO Stéphane Bancel and other executives—services that may include personal protection as well as efforts to safeguard its intellectual property. Meanwhile, the government watchdog Public Citizen has called for an investigation into the “unprecedented” collaboration between Biogen and the FDA on the review of the Alzheimer’s treatment aducanumab. Those stories, plus our list of the top 10 pharma R&D budgets, follow below. | |
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Featured Story | By Eric Sagonowsky Moderna stepped onto the world stage last year when it pivoted its mRNA research to target COVID-19, scaled up manufacturing, staffed up in sales and marketing and then launched a highly effective shot. And under that spotlight, CEO Stéphane Bancel and his team needed backup, Moderna decided. read more |
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Top Stories Of The Week By Ben Adams While 2020 was a year to forget for almost the entire globe, the R&D engine of pharma roared to life in a never-before-seen way by creating new drugs, vaccines and tests for the pandemic that ravaged the world. read more By Nick Paul Taylor A government watchdog has called for an investigation into the “unprecedented and inappropriate close collaboration” between Biogen and the FDA on the aducanumab filing in Alzheimer’s disease. read more By Angus Liu In a stunning revelation, FibroGen admitted to presenting roxadustat data manipulated to make the anemia drug look safer than it is. The late-Tuesday announcement sent FibroGen shares tumbling and prompted analysts to reassess the potential first-in-class therapy ahead of an FDA decision. read more By Eric Sagonowsky AstraZeneca’s COVID-19 vaccine rollout has spurred concerns over blood clots in Europe, but after an urgent review, the bloc's top drug regulator offered fresh backing last month. Now, a European Medicines Agency official says the vaccine is linked to rare blood clots, but that the benefits of vaccination still outweigh the risks. read more By Nick Paul Taylor Novavax has added crossover arms to late-phase clinical trials of its COVID-19 vaccine. The action will enable participants in the placebo cohorts of the original trials to get vaccinated without unblinding the studies. read more By Ben Adams China’s Legend Biotech and Janssen have finished off the rolling submission to the FDA for their partnered cell therapy hopeful cilta-cel. read more By Kevin Dunleavy The U.S. will help AstraZeneca find a new manufacturer for its COVID-19 vaccine after ordering Johnson & Johnson's takeover of an error-prone Emergent plant in Baltimore. read more By Arlene Weintraub A Penn team found that Pfizer’s lung cancer treatment Vizimpro (dacomitinib), the antibiotic salinomycin and anti-rejection drug cyclosporine inhibited SARS-CoV-2 in respiratory cells. The study also shed light on the varied mechanisms the virus uses to invade different types of cells. read more By Angus Liu AbbVie has pegged multibillion-dollar hopes on Rinvoq to fill the revenue gap when immunology superstar Humira loses U.S. market exclusivity. But that plan, dependent on multiple label expansions, has hit its second regulatory setback in weeks—this time in atopic dermatitis. read more By Conor Hale It's been a busy day for Invitae. The genetic testing provider inked a $200 million buyout and wrapped up a hefty investment from a group of backers marshaled by SoftBank. read more Resources 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? 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Sponsored By: Almac Clinical Technologies This industry report reveals qualitative and quantitative candid insight from clinical development insiders and their views on current clinical trial challenges faced amidst uncertainty. 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. | 