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WELCOME TO FIERCE LIFE SCIENCES WEEKLY DIGEST

Our annual list of the highest-paid in biopharma R&D has some familiar faces and some wild cards, as the mad dash against COVID-19 brought along several pay raises. That includes CSO Gregory Glenn, whose Novavax recently posted 90.4% efficacy in a U.S. study. Meanwhile, a U.K. real-world study of Pfizer, BioNTech and AstraZeneca’s vaccines showed they could work against the coronavirus’ Delta variant, aka B.1.617.2, one of the predominant strains in the country. Elsewhere, CureVac’s first-generation shot missed the mark with 47% accuracy, but it’s second-gen vaccine is in the works with help from GSK.

Featured Story

Two shots of Pfizer, AstraZeneca COVID-19 vaccines effective against Delta variant: study

In a real-world study in the U.K., two shots of the Pfizer or AstraZeneca COVID-19 vaccine were effective in preventing hospitalizations caused by the Delta variant, which scientists first detected in India.

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Top Stories Of The Week

Novavax COVID-19 vaccine hits 90% efficacy in pivotal U.S. trial

Novavax’s COVID-19 vaccine candidate has achieved 90.4% efficacy in the pivotal trial designed to support U.S. approval. The phase 3 data set Novavax up to file for approval in the third quarter.

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SPECIAL REPORT—The top 10 highest paid biopharma R&D executives in 2020

If you (like us) thought George Yancopoulous, M.D., Ph.D., would top this list, well, that would have been a pretty safe bet. What none of us predicted was just how big his lead would be. The Regeneron R&D chief raked in $134.3 million, a whopping 550% bump over his compensation the previous year. Yancopoulos' compensation eclipsed the pay of his peers on this list by at least $109 million.

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Biogen's $56K price on Aduhelm 'simply unacceptable,' Alzheimer's Association says after vouching for FDA approval

The Alzheimer's Association, which has been a leading advocate for Biogen's drug Aduhelm, said the drugmaker's roughly $56,000 per year list price is "simply unacceptable" and called on the company to change it.

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GSK pays iTeos $625M upfront to join Merck, Roche and the rest in TIGIT immuno-oncology race

GlaxoSmithKline is paying iTeos Therapeutics $625 million upfront for rights to phase 1 anti-TIGIT monoclonal antibody EOS-448. The deal sets GSK up to challenge Bristol Myers Squibb, Gilead, Merck and Roche for the red-hot corner of the immuno-oncology market. 

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'Place them in the trash': FDA warns against using Innova's rapid COVID-19 antigen tests

The FDA issued a stark warning to the public urging them to stop using rapid COVID-19 antigen tests developed by Innova Medical Group, the company previously tapped by the U.K. for hundreds of millions of kits.

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How did 75M J&J vaccines get ruined? FDA details the manufacturing woes at Emergent's beleaguered site

At long last, several million doses of Johnson & Johnson's COVID-19 vaccine made at CDMO Emergent BioSolutions' troubled Baltimore production facility have been cleared for use. But many more are now bound for the graveyard, and the feds are going public with the reasons behind the ruined doses.

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He authorized Moderna's vaccine 6 months ago. Now, ex-FDA chief Hahn joins biotech's backer

Ex-FDA Commissioner Stephen Hahn, M.D., is joining Moderna incubator Flagship Pioneering six months after granting the company an emergency use authorization for its COVID-19 vaccine.

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Slashing 186 jobs, Novartis hands off U.S. sales, marketing duties for migraine med Aimovig to Amgen

Facing heavy competition, Aimovig's U.S. operations will undergo a shakeup. Novartis on Tuesday said that it will hand shared U.S. business operations for the med to Amgen, including sales, marketing and medical support functions. The Swiss pharma will retain the financial aspects of its current U.S. collaboration with Amgen, including sharing costs and receiving royalties.

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Boehringer, Lilly and Takeda join matchmaker PharmStars' digital health accelerator

Just weeks after its debut, the PharmStars digital health accelerator nabbed its first pharma members—Boehringer Ingelheim, Eli Lilly and Takeda. The new matchmaking company is the first of its kind to focus specifically on connecting drugmakers to digital health startups.

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Diabetes mainstay metformin tamps down lung inflammation in COVID models

The 27-year-old diabetes drug metformin has been studied for its potential use in a wide range of other disorders, including heart disease and cancer. Now researchers led by the University of California, San Diego say the diabetes mainstay might help prevent lung inflammation in patients with COVID-19.

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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

Whitepaper: COVID-19 Survey report: The Lasting Impact on Outsourcing Decisions

How has COVID-19 impacted CRO/CDMO customer (dis)satisfaction and outsourcing decisions for pharma and biotech companies in 2021 and beyond?

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.