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Today's Rundown

Featured Story

AstraZeneca's COVID-19 therapy hits goal in phase 3, but efficacy falls short of rivals

AstraZeneca has chalked up another win for its anti-SARS-CoV-2 antibody combination, revealing the prospect cut the rate of severe COVID-19 or death in patients recently infected with the coronavirus. But with AstraZeneca arriving late to the market with efficacy results that fall short of its rivals, the commercial prospects of AZD7442 in the treatment of COVID-19 are uncertain.

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Top Stories

Sponsored: Purify DNA, RNA, proteins, and cells for many applications

Discover ways your Thermo Scientific™ KingFisher™ system can empower your research beyond SARS-CoV-2.

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Merck makes beeline to FDA, seeking approval for COVID-19 antiviral 10 days after reporting data

Merck isn’t hanging around. Ten days after reporting data on its oral COVID-19 antiviral molnupiravir, Merck has filed for emergency use authorization from the FDA as part of a rapid global push to get the drug to patients.

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Protagonist's story gets a happy ending as FDA's hold swiftly lifted on rusfertide program

A month ago, Protagonist Therapeutics saw its shares more than halved on an FDA clinical hold of its blood cancer drug after worrying preclinical safety signals.

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Sponsored: Partnership to unlock the full potential of data to advance the science and practice of healthcare: Q&A with Syntropy and the University of California, Irvine

Q&A with Syntropy and UCI on their collaboration to work across their enterprise and with external partners to advance health research and patient care.

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Idorsia's Fabry med did what executives were expecting—it just didn’t relieve the disease's hallmark burning pain

Idorsia’s Fabry disease therapy “did exactly what we were expecting,” according to one executive—except relieve neuropathic pain. That means lucerastat failed in a phase 3 clinical trial in adult patients with Fabry disease, a rare metabolic disorder that causes episodes of severe burning pain and can eventually lead to kidney failure or cardiac disease.

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He led Bayer's $1B Parkinson's bet. Now, Nuwaysir will helm Takeda-partnered Ensoma

Emile Nuwaysir led the $1 billion bet that Bayer placed on Parkinson's via its BlueRock Therapeutics subsidiary. Now, the chairman of the Alliance for Regenerative Medicine will take the reigns at Ensoma, a gene therapy biotech that launched with $70 million and a Takeda partnership in February.

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Senate to cull Biden's biomedical research agency from social care bill: Report

President Joe Biden’s $3 billion Advanced Research Projects Agency for Health is in jeopardy as the Senate is set to cut the agency from its social care spending bill.

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Protalix reaches agreement with FDA on Fabry data package, but resubmission of PRX–102 could be years out

Protalix BioTherapeutics sees a path forward for resubmitting an application for a Fabry disease medicine with the FDA; it’s just going to take a while. The Israeli biotech received a complete response letter from the FDA for PRX–102, or pegunigalsidase alfa, in April.

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Brain atlas unveils dozens of cell types that control movement and could inspire targets in neurological disease

A Berkeley-led team discovered that the primary motor cortex in the brain, which controls movement, houses up to 116 distinct cells—five times more than had been identified in previous research. The research is part of the National Institutes of Health's BRAIN Initiative, a massive research effort aimed at the world’s understanding of the human neurological system.

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Biden doubles down on vaccine mandates, pointing to increased uptake and limited resignations

In a speech and new report, the U.S. president pointed to data indicating major increases in employee vaccination rates and relatively few resignations following vaccination requirements. About 40% of all U.S. hospitals have publicly announced a vaccination requirement for their workforce.

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GlaxoSmithKline to leave landmark global HQ after split-up as consumer health business plots £120M new home

GSK will leave its iconic glass-façade corporate headquarters in London, known as the GSK House, after 2023 at the earliest. The outgoing consumer health business will invest £120 million to build its own campus in Weybridge, U.K.

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Deep Lens pens cancer trial matchmaking pact with Pacific Cancer Care

Deep Lens is looking to help the right cancer patients get into the right trials and is teaming up with Pacific Cancer Care to help in its mission.

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Mount Sinai unveils first-of-its-kind department to develop AI tools for healthcare

Many hospitals and health systems talk a big game about integrating artificial intelligence into nearly every aspect of clinical care, but Mount Sinai, for one, is actually putting its money where its mouth is.

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Resources

Whitepaper: Applications of Digital Twins in Clinical Trials for Alzheimer’s Disease

Read Unlearn’s whitepaper to learn about how novel trial designs with Digital Twins enable more efficient clinical trials, with higher power and smaller required sample sizes.

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?

Paid Marketplace: Online Graduate Programs Designed for Your Career

Drexel University’s online graduate programs in biomedicine, clinical research, drug discovery, and molecular medicine were developed with working professionals in mind, providing you with the education, practical skills, and competitive edge you need to be successful in your career. Learn more.

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.

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.

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: 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.

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