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Today's Rundown

Featured Story

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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Top Stories

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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J&J's Burton grabs hold of Moderna rocket ship as the vaccine developer’s next chief medical officer

Moderna launched itself into the big leagues last year with its COVID-19 vaccine, and now it's poaching talent from the world’s biggest healthcare company. Paul Burton, M.D., Ph.D., will join the Cambridge, Massachusetts-based biotech as chief medical officer from Johnson & Johnson’s Janssen unit.

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Sponsored: Inside Track: Behind the Scenes of a Major Biotech SPAC

Take a closer look at the SPAC phenomenon with Dr. David Hung, Founder and CEO of Nuvation Bio and Michelle Doig, Omega Funds Partner and President of its Omega Alpha SPAC.

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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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Humanigen angling to go from zero to $1B with U.S., U.K. COVID-19 therapy filings

Humanigen could go from zero to $1 billion in sales if its COVID-19 treatment clears regulatory review in the U.S. and U.K., analysts from Cantor Fitzgerald said today. The self-described “cytokine storm company” filed a rolling submission in the U.K. Monday for lenzilumab in hospitalized COVID-19 patients. This follows a May 28 authorization request submitted to the FDA.

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Celltrion's COVID-19 antibody gets a phase 3 win as virus variants snare existing therapies

Chalk one up for COVID-19 antibodies: Celltrion’s prospect, regdanvimab, beat placebo at preventing hospitalization and death in patients with mild to moderate symptoms and helped those patients recover more quickly in a phase 3 study. The results arrive as the rise of SARS-CoV-2 variants raise concerns about existing antibody drugs, especially those given as single agents.

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Flagship Pioneering flags down another $2.2B to expand preemptive, pioneering medicine divisions

Flagship Pioneering wanted a little more heft behind its latest voyage. The biotech innovator and venture firm increased its April 2020 fund from $1.1 billion to a total of $3.37 billion on Monday to drive a preemptive medicine focus.

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HiFiBiO gets high-five from investors with $75M series D to bring two programs into clinic

HiFiBiO has another $75 million to take two lead antibody oncology programs into the clinic and continue the phase 1 study of its COVID-19 antibody candidate. Mirae Asset Financial Group led the Series D round alongside half a dozen other new investors like B Capital Group.

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EHA: Epizyme's first-in-class multiple myeloma drug candidate inhibits tumors in mice

Epizyme has reported positive data from mouse studies for a potential first-in-class multiple myeloma therapy. The drug, a small-molecule SETD2 inhibitor dubbed EPZ-719, significantly slowed tumor growth in mice, according to data presented at the European Hematology Association virtual congress.

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Johnson & Johnson told to throw out 60M COVID-19 shots made at troubled Emergent site: report

The FDA has instructed Johnson & Johnson to toss about 60 million COVID-19 vaccines made at Emergent BioSolutions' troubled factory in Baltimore, Maryland, the New York Times reports.

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Here's why Abernethy wanted to jump on board at Verily and her ambitions to grow its research business

Verily's recent hiring of former FDA official Amy Abernethy, M.D., Ph.D., signals it has strong ambitions to transform research to make it easier and faster to run clinical trials. Abernethy recently chatted with Fierce Healthcare about her move to the Alphabet life sciences venture and her vision to grow the company's clinical research business.

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Resources

Whitepaper: How the rapid shift to point-of-care is reshaping diagnostics

Learn how the diagnostics industry is being fundamentally transformed with point-of-care molecular testing.

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.

Paid Marketplace: Story of Success: Ashfield Healthcare Empowers Field Sales to Grow Market Share based on Data

Discover how Ashfield Healthcare uses the power of data and analytics to enable pre-call planning, inform sales rep actions and drive higher market share for its target pharmaceutical products.

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.

eBook: The New Standard: Virtual Study Training in Clinical Trials

The new standards in study training help sponsors and CROs reduce costs by 60%, cut training time by 50%, and start enrollment 55 days faster – learn more today.

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. 

eBrief: Drug Product Process Development: Ensuring a Consistent, High-quality Biologic

Learn about drug product process development challenges and risks, the difference between innovator and biosimilar drug product process development, and more during the drug product process development phase.

Whitepaper: Achieving a Successful Drug Product Technology Transfer

Get insights on key considerations for a successful tech transfer process for manufacturing a biologic drug product, including a case study on overcoming challenges in a process transfer for a sterile diluent.

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