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WELCOME TO FIERCE LIFE SCIENCES WEEKLY DIGEST

The COVID-19 pandemic showed mRNA-based vaccines can be highly effective against the coronavirus—now the race begins to take on the seasonal flu. Sanofi and Translate Bio launched a phase 1 trial of their shot, leap-frogging Pfizer and Moderna—the latter of which has three influenza vaccines in development, and plans to enter the clinic this year. Meanwhile, Novavax showed its nanoparticle approach can perform just as well, if not better, but manufacturing logistics may delay it from entering the saturated U.S. market. Guess the company will have to settle for supplying the rest of the planet, which analysts describe as a multibillion-dollar opportunity for Novavax over the next five years.

Featured Story

Tension builds at GlaxoSmithKline as activist investor Elliott plots CEO Walmsley's removal, vaccine split: FT

In the run-up to a closely watched investor day scheduled for Wednesday, pressure is rising at GlaxoSmithKline. As CEO Emma Walmsley is slated to lay out her plan for a “new GSK,” activist investor Elliott Management is reportedly rallying support for her ouster as well as further splitting the company with an eye on hiving off the vaccines business.

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Top Stories Of The Week

Sanofi, Translate Bio start seasonal mRNA flu vaccine trial, gaining early lead over Moderna and Pfizer

Sanofi and Translate Bio have started a phase 1 clinical trial of an mRNA vaccine for seasonal influenza. The initiation of the study puts the partners ahead of Moderna and Pfizer in the race to show mRNA vaccines are as good or better at preventing flu than existing technologies. 

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Special Report—The top 10 ESG pharma companies in 2021

Environmental, Social and Governance (ESG) is the new corporate sustainability yardstick. And investors are pushing ESG accountability—thanks in part to the pandemic—to the front page across industries, including pharma.

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Novavax's COVID-19 shot won't see much U.S. use, but a big global market awaits: analyst

Because of development delays, Novavax should expect little uptake for its COVID-19 vaccine in the United States. But there's still a ready market globally, which the shot is well equipped to serve, GlobalData analysts report.

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Gilead's Kite makes off-the-shelf play with Shoreline Biosciences CAR-NK deal worth as much as $2.3B

Gilead’s Kite unit made its name developing autologous CAR-T treatments made from a patient’s own cells. Now, the subsidiary is making another big play in off-the-shelf treatments that can be developed more quickly in a deal with Shoreline Biosciences that could exceed $2.3 billion. The partners will initially work on CAR targets for natural killer cell therapies for blood cancers.

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Key senator calls for Woodcock's removal as FDA fallout from Biogen Alzheimer's approval heats up

Sen. Joe Manchin, a moderate Democrat from West Virginia, told President Joe Biden in a letter that interim FDA Commissioner Janet Woodcock is "not the right person to lead the FDA" following the agency's controversial decision to approve Biogen's Alzheimer's drug Aduhelm.

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New COVID-19 approach exploits protein response in human cells to combat virus

The development of COVID-19 drugs has mostly focused on directly targeting the SARS-CoV-2 coronavirus. But scientists at the University of Cambridge are taking a different approach to treating the disease by looking at an infection response pathway in human cells.

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U.K. doubles down on Innova's rapid COVID-19 test, after FDA urged users to throw it away

After the FDA urged anyone who had Innova Medical Group’s COVID-19 antigen test to stop using it and toss it in the trash, regulators across the pond have re-reviewed and now cleared the rapid diagnostic's use, while also extended its authorization.

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Meet Hugo: Medtronic's robotic-assisted surgery system makes global debut in Chilean clinic

The medtech giant’s Hugo system was used in its first-ever patient procedure June 19, a prostatectomy performed in Santiago, Chile.

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AstraZeneca, Novavax partner SK Bioscience eyes $132M vaccine production boost—and looks to add mRNA to the menu

COVID-19 production pacts have elevated the profile of numerous biopharmas during the pandemic, and that's certainly true for AstraZeneca and Novavax's partner SK Bioscience. The company is now channeling its recent momentum into a sizable manufacturing expansion at home.

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Pfizer, Roche, Teva grab pharma Cannes Lions for 2021, but a wearable company scores the top creativity prize

Cannes Lions awarded the pharma Grand Prix winner—highly anticipated after last year’s festival cancellation—to a non-pharma company. Woojer audio wearable company, along with its agency FCB Health’s Area 23, won for its music, tech and wearable solution for people with cystic fibrosis.

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Roche's Alzheimer's antibody lowers biomarkers in inherited form of disease, though impact on symptoms is unclear

Experimental anti-amyloid antibodies from Eli Lilly and Roche failed to improve symptoms of Alzheimer’s disease in a phase 2/3 study, but analysis of the the trial continued. Now, the investigators at Washington University are extending the trial of Roche’s drug based on findings suggesting it may help a subset of patients.

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Resources

Whitepaper: How to Launch a Successful BYOD Strategy in Any Phase

For faster deployment, improved patient engagement, and better-quality data — go where your patients are. GO BYOD with Lunexis™ from Clinical Ink.

eBook: Improving Diversity and Inclusion in Clinical Trials

Create a more diverse and inclusive clinical trial enrollment and engagement environment by learning the barriers to participation and the strategies to overcome them.

Whitepaper: Closed Cell Processing System Benefits for Cell & Gene Therapy

Autologous cell and gene therapy workflows involve isolating cells from an individual, engineering the cells, expanding and concentrating them, and infusing them back into the patient. Optimized automation of certain steps of the workflow may decrease hands-on time and the cost of the cell manufacturing process.

Guide: Your Guide to Overcome Inconsistent Clinical Data Standards

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.

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.

Content Hub: Process Intensification Resource Center

A one-stop hub for Cytiva resources to support process intesification

Content Hub: Emerging Biotech Resource Center

A one-stop hub for Cytiva resources to support process development and manufacturing of your novel molecule

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. 

Content Hub: How to improve the virtual work you do every day

We enable virtual work — offering over-time sessions where participants are more focused, insights are more diverse and business goals are met.

Webinar: Age-Appropriate Formulation Development for Pediatric Trials-Challenges and Considerations

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.

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.

Q&A: Planning Successful Launches

Learn about proven strategies for a successful product launch, including cross-functional team collaboration, risk management and using the right project management tools.