WELCOME TO FIERCE LIFE SCIENCES WEEKLY DIGEST It was bad enough when studies found AstraZeneca’s vaccine was largely ineffective against the aggressive coronavirus mutation emerging in South Africa—but now, analysts fret the shot’s distributed manufacturing network could give the FDA pause. Meanwhile, researchers in China made headway with one of the original goals of mRNA vaccine technology—before it was drafted into the COVID-19 effort—by combining it with hydrogel and using it to fight cancer. And Moncef Slaoui’s work isn’t slowing down after Warp Speed: he’s launching a new company that’s 10 biotechs in one. Those stories, plus our top reads of the week, follow below. | |
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Featured Story | By Arlene Weintraub It's not just the worrisome data showing AstraZeneca’s COVID-19 vaccine was largely ineffective against the aggressive South African variant that worries some analysts. Inconsistent manufacturing could complicate the company's bid to win over the FDA for a U.S. launch. read more |
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Top Stories Of The Week By Ben Adams Bristol Myers Squibb is putting down up to $1.3 billion on a next-gen engineered toxin body cancer platform from Molecular Templates as it cuts an unwanted cell therapy from its Celgene buyout. read more By Nick Paul Taylor Bluebird bio has suspended two clinical trials of its sickle cell disease gene therapy after participants developed acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). During the pause, bluebird will evaluate whether the BB305 lentiviral vector is linked to the cases of AML and MDS. read more By Beth Snyder Bulik GlaxoSmithKline plans to shut down antibiotics production in the U.K. after wrapping up a $500 million product sale to Novartis’ Sandoz. GSK will finish out its commitment to manufacture the cephalosporin meds for Sandoz—a deal that lasts through 2025—as it prepares to shutter one site and downsize another, cutting 300 jobs in the process. read more By Eric Sagonowsky Novartis' heart failure drug Entresto has been on the ascent after a slower-than-expected debut on the market, and now the drug has an expanded FDA label that could widen its reach to millions of new patients. read more By Angus Liu Scientists at China’s National center for Nanoscience and Technology have designed a hydrogel to deliver an mRNA vaccine with an immune-stimulating adjuvant. When injected into mice with melanoma, the vaccine stayed active for at least 30 days, inhibiting tumor growth and preventing metastasis. read more By Amirah Al Idrus When Moncef Slaoui resigned as co-leader of Operation Warp Speed last month, he said it was time to "move on and go back to my private life and private business." Now, he’s revealing his next act: Centessa Pharmaceuticals, an amalgamation of 10 biotech companies that starts out with $250 million and Bristol Myers Squibb veteran Saurabh Saha at the helm. read more By Fraiser Kansteiner Britain's drug regulator is auditing Serum Institute of India's manufacturing processes, potentially teeing up imports of India-made AstraZeneca vaccines to the U.K. and Europe. The move comes as AstraZeneca hustles to boost EU shot supplies—and after the pharma giant last week suggested it could source doses from production facilities outside the region. read more By Eric Sagonowsky After Breyanzi's long-and-winding path to an FDA approval, Bristol Myers Squibb is diving into the complex CAR-T lymphoma market—a market already dominated by Gilead Sciences and Novartis therapies. Still, the company has worked up its talking points, an exec said, and has big plans for the road ahead. read more By Conor Hale Medtronic has launched a global recall of its Valiant Navion thoracic stent graft system, used to reinforce large blood vessels at risk of rupturing from an aneurysm or other injuries. read more Resources Sponsored By: Within3 We enable virtual work — offering over-time sessions where participants are more focused, insights are more diverse and business goals are met. Sponsored by: Catalent 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. Sponsored By: Medidata, a Dassault Systèmes company 8 parameters to optimize your “Path to Virtualization” across site- and patient-centric capabilities in this Sponsor Edition eBook. 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Sponsored by: Catalent Learn about proven strategies for a successful product launch, including cross-functional team collaboration, risk management and using the right project management tools. Sponsored by: Catalent Learn about a real-world example of how clinical supply management expertise was applied to overcome inventory challenges for a complex, global study. Sponsored by: Catalent Whether a study is simple or highly complex, forecasting and simulation reports serve as data driven communication tools to help minimize risks and keep the study on track. Learn more about forecasting solutions for informed decision making and supporting contingency planning for clinical study. | 
