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WELCOME TO FIERCE LIFE SCIENCES WEEKLY DIGEST

The FDA’s clinical hold of Allogene’s off-the-shelf CAR-T trials sent shockwaves through the field, after a chromosomal abnormality was found that could theoretically cause cancer. Meanwhile, CRISPR Therapeutics’ CAR-T candidate showed responses in 58% of study patients, but questions about long-term durability still dragged the company’s shares down. Elsewhere, private equity firms are reportedly sizing up GSK’s consumer health unit, which could be worth $54 billion on its own. The planned spinout will also see GSK leave its iconic London headquarters, though the company said it plans to find a new site in the area. Those stories, plus our other top reads of the week, follow below.

Featured Story

FDA stops all Allogene's CAR-T trials over safety scare, raising questions about future of gene editing

The FDA has sent shockwaves through the off-the-shelf CAR-T space, slapping a clinical hold on all of Allogene Therapeutics’ AlloCAR T clinical trials in response to an abnormality that could theoretically cause cancer.

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Top Stories Of The Week

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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Spinoff or $54B sale? GlaxoSmithKline's consumer health outfit draws buyout interest: report

As GlaxoSmithKline approaches the end of a two-year journey to spin off its consumer health joint venture with Pfizer, the demerger pathway suddenly looks less certain. Several private equity firms are reportedly sizing up the unit, which could be valued at $54 billion.

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Philips makes the scanner a playground to ease children through a scary MRI

Philips launched a digital coach to help parents and children cope with the stress of the procedure and get out the jitters before having to lie still for a clean image.

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UPDATE: CRISPR hails safety, efficacy of off-the-shelf CAR-Ts, but stock slides amid durability doubts

CRISPR Therapeutics’ off-the-shelf CAR-T therapy has fallen short of the high bar set by investors. The prospect triggered responses in 58% of patients without causing grade 3 or higher cytokine release syndrome, but six-month durability compared unfavorably to rival drugs, sending shares in the biotech down 8%.

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Moderna criticized for COVID-19 vaccine strategy putting once feel-good success story in jeopardy

Moderna has no intention of sharing its mRNA vaccine formula with the rest of the world, the company's chairman said on Tuesday. Once seemingly immune to criticism, Moderna is hearing lots of it recently. The company lags far behind other COVID vaccine producers in supplying shots to poorer nations.

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Eli Lilly's Verzenio snags first-in-class FDA approval for early breast cancer. But limited label poses a challenge

As a late entrant in the breast cancer race, Eli Lilly has leapt ahead of rivals Pfizer and Novartis with a first-in-class FDA approval for Verzenio. But a patient population restriction is adding what Lilly Oncology chief called “a legitimate challenge” to the launch.

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Boston biotech backers quit Dana-Farber board after U-turn on investment policy: report

Dana-Farber Cancer Institute has reportedly barred trustees from newly investing in biotechs created to license its science, leading to the resignation of board members including a co-founder of C4 Therapeutics.

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Novel protein degrader against 'undruggable' cancer target inhibits tumors in mice

Riding a growing interest in protein degradation, researchers at the Indiana University School of Medicine identified a small-molecule degrader for a cancer-promoting target called SUMO1, which was previously considered "undruggable." The compound inhibited tumor growth in mouse models of human breast, colon and lung cancers being developed by startup HB Therapeutics.

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Boehringer capacity exceeds original forecast at new $809M Austrian plant

Boehringer Ingelheim’s new $809 million manufacturing facility, which officially opened this month in Vienna, boasts a production capacity of 185,000 liters, exceeding its original planned capacity of 150,000 liters.

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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.

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.

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.

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.

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.