WELCOME TO FIERCE LIFE SCIENCES WEEKLY DIGEST Researchers retracted a preprint study that had falsely calculated a 1 in 1,000 risk of cardiac complications from Moderna and Pfizer-BioNTech’s mRNA vaccines—saying the finding was the result of a “major error” in the data, and that the true rate of the COVID shots’ side effects would be closer to 1 in 25,000. Meanwhile, Merck said its COVID antiviral pill could halve the risk of hospitalizations or death, gearing the company up for an FDA emergency authorization. Finally, the Fierce Pharma Marketing Awards highlighted the stunning creativity of companies large and small, after a year where it seemed creativity faced an uphill climb. Those stories follow below. | |
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Featured Story | By Angus Liu In the past few weeks, anti-vaxxers have rallied behind a nonpeer-reviewed study by a group of Canadian researchers as evidence against COVID-19 vaccines. Turns out, the paper made a fatal mistake in reaching its conclusion. read more |
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Top Stories Of The Week By Nick Paul Taylor The wait for an oral antiviral against COVID-19 may almost be over. Friday, Merck reported its prospect halved the risk of hospitalization and death in phase 3, spurring it to stop the study and race to get emergency use authorization. read more By Beth Snyder Bulik After a year when it seems like creativity should have hit a pause, the Fierce Pharma Marketing Award winners are proof of just the opposite. read more By Annalee Armstrong After years in development, the floodgates for RSV vaccines may open up soon, with more and more Big Pharmas piling on data. Now, Johnson & Johnson’s Janssen is adding to the fray, announcing efficacy as high as 80% in preventing severe infections in a mid-stage clinical trial. read more By Conor Hale Medtronic unveiled three new products that it's adding to its portfolio of tools for minimally invasive spine surgery. The latest offerings focus on TLIF procedures and join up with the medtech giant’s suite of navigation, AI and robotics technologies. read more By Angus Liu Many companies have shifted their way of working amid COVID-19. Adjusting to how work is done these days, GlaxoSmithKline is downsizing its office footprint in the U.S. by moving to new locations. read more By Eric Sagonowsky AstraZeneca has already faced one high-profile personnel issue this year in a case that resulted in a $2.4 million jury award for a former sales manager. Now, the company is paying up to resolve allegations of race- and gender-based pay discrimination for hundreds of sales reps. read more By Nick Paul Taylor The race to use bispecifics to treat blood cancers is heating up, with Johnson & Johnson paying $100 million upfront to challenge Regeneron and Roche in a field that looks set to be highly competitive. read more By Angus Liu Merck hopes its $11.5 billion Acceleron buy will quickly wrap up in the fourth quarter. But revolt from an activist investor threatens to derail that plan. Avoro Capital, known for nixing Immunomedics’ tie-up with Seattle Genetics, slammed Merck’s $180-apiece price “drastically undervalues” Acceleron. read more By Kevin Dunleavy COVID-19 vaccine producer Moderna and Japanese partner Takeda have concluded that “human error” caused the presence of metallic particles in vials discovered five weeks ago in Japan. The errors occurred at a Rovi manufacturing plant in Spain, which released three vaccine lots after a fourth lot from the same production series failed an inspection. The particles were stainless steel and resulted from mistakes made during a production-line changeover, the 16-page report said. read more By Arlene Weintraub University of California researchers produced a map of protein interactions in cancer, uncovering previously unrecognized mutations they believe could drive metastasis. The detailed insights that emerged could explain disparities in the effectiveness of cancer drugs while also leading to new drug targets, they believe. read more | | Webinar: New ctDNA Data in Response Monitoring Thursday, October 14 | 11am ET / 8am PT Discover improvements to clinical trial design with Signatera including: identifying early relapsers, enriching for patients potentially most likely to respond to therapy, accelerating time to trial readout, predicting clinical outcomes as early as 6 weeks into treatment. Learn More. |
Resources Sponsored By: Trial Interactive Check out the eTMF Implementation Quick Guide to see a checklist TMF experts developed to help you reduce risks, maintain compliance, and establish effective processes in your eTMF. This whitepaper addresses where AI can make the biggest impact in clinical trials. Sponsored by: Thermo Fisher Scientific Looking to accelerate your biotech company, but not sure where to start? Sponsored by: Oracle Health Sciences New research indicates an accelerated adoption of decentralized clinical trials due to COVID-19. Sponsored by: LabVantage Solutions Shift from data collection to data science. Add advanced analytics to your lab informatics platform to yield valuable, action-ready insights from LIMS and other data. Sponsored by: Thermo Fisher Scientific Integrate supply chain simulation into your early clinical trial planning to minimize risk in an uncertain supply chain environment, improve supply chain outcomes, and help streamline time-to-market for innovative therapies. Sponsored by: WCG Every biopharma sponsor faces the challenge of initiating, running and closing trials on time, but oncology studies pose several unique hurdles. 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: 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. | 