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 | By Nick Paul Taylor 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. read more |
| |
|---|
|
Top Stories Of The Week By Angus Liu 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. read more By Angus Liu 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. read more By Conor Hale 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. read more By Nick Paul Taylor 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%. read more By Kevin Dunleavy 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. read more By Angus Liu 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. read more By Nick Paul Taylor 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. read more By Angus Liu 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. read more By Joseph Keenan 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. read more | | Webinar: Clinical Adjudication Survey Results Revealed Tuesday, November 2 | 1pm ET / 10am PT In a recent survey, 89% of clinical adjudication users agreed clinical adjudication provides value to clinical trials. Join two Bioclinica experts for a discussion of these and other survey results to understand how they could impact your studies. Register Now. |
Resources Sponsored By: Unlearn AI 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. Sponsored By: Trial Interactive 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. Sponsored By: Unlearn AI This whitepaper addresses where AI can make the biggest impact in clinical trials. Sponsored by: Catalent 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. Sponsored by: Thermo Fisher Scientific Looking to accelerate your biotech company, but not sure where to start? Sponsored by: Oracle Health Sciences New research indicates an accelerated adoption of decentralized clinical trials due to COVID-19. Sponsored by: LabVantage Solutions 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. Sponsored by: Thermo Fisher Scientific 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. Sponsored by: WCG Every biopharma sponsor faces the challenge of initiating, running and closing trials on time, but oncology studies pose several unique hurdles. Sponsored by: Catalent 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. Sponsored by: Box Read Get to Know Cloud Content Management for Life Sciences and learn how to eliminate silos across all workflows, from R&D to commercialization. Sponsored By: Remarque Systems 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. | 