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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.

Featured Story

Researchers retract preprint study that miscalculated higher heart inflammation risk for Moderna, Pfizer COVID vaccines

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.

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Top Stories Of The Week

UPDATED: Merck's oral COVID-19 antiviral slashes hospitalizations, prevents deaths in phase 3, sparking race to file with FDA

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.

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The 2021 Fierce Pharma Marketing Awards

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.

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J&J's RSV vaccine offers 80% efficacy against severe illness in a race crowded by Big Pharmas

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.

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Medtronic expands minimally invasive spine surgery portfolio with 3 additions

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.

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GlaxoSmithKline relocates US operations in Philadelphia, North Carolina as COVID-19 cuts its office space needs

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.

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AstraZeneca underpaid hundreds of female and Hispanic sales reps, feds say

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.

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J&J spends $100M upfront, with $1.2B in biobucks, to join Roche and Regeneron in bispecific blood cancer race

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.

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Trouble builds for Merck's $11.5B Acceleron buy as activist investor behind Gilead's Immunomedics deal says too early, too cheap

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.

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Moderna report says 'human error' to blame for contamination found in 3 vaccine lots from Rovi plant

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.

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New map of protein interactions offers opportunity to 'do such damage to cancer,' scientists say

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.

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Resources

Research: eTMF Implementation Quick Guide

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.

Whitepaper: Modernizing Key Clinical Trial Processes with Artificial Intelligence

This whitepaper addresses where AI can make the biggest impact in clinical trials.

Free Infographic: Identifying Opportunities for Biotech Scale-Up

Looking to accelerate your biotech company, but not sure where to start?

Report: New research indicates an accelerated shift to decentralized clinical trials

New research indicates an accelerated adoption of decentralized clinical trials due to COVID-19.

Whitepaper: Transform LIMS Data into Action-Ready Insights with Advanced Analytics

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.

Whitepaper: Clinical trial simulation: Advanced modeling techniques enable data-driven supply chain planning

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.

Whitepaper: Big Challenges for Small Sponsors: Competition in Oncology Research

Every biopharma sponsor faces the challenge of initiating, running and closing trials on time, but oncology studies pose several unique hurdles.

eBook: Get solutions to market faster

Read Get to Know Cloud Content Management for Life Sciences and learn how to eliminate silos across all workflows, from R&D to commercialization.

Content Hub: Remarque Systems Resource Hub

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. 

eBrief: Manufacturing Strategies to Effectively Industrialize Autologous Cell Therapies

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.