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Today's Big News Sep 20, 2022 Merck finally gets FDA nod to relaunch HIV trials, but drops preventive therapy plans Rocket inks Renovacor buyout to propel its heart disease gene therapy ambitions Fierce Biotech Summit: As the biotech market teases turning a corner, stakeholders say we're in a 'new normal' Alzheon's Alzheimer's asset axes brain injury biomarker in phase 2 trial Clover touts phase 3 omicron data as wait for COVID-19 vaccine approvals drags on Thought COVID was bad? DOD taps Evotec to bolster its defenses against bubonic plague By James Waldron A path forward for Merck & Co.’s struggling HIV strategy has opened up, with the FDA releasing a nine-month clinical hold on trials of the Big Pharma’s drug islatravir as long as low doses are used. However, the company has also decided to ditch its plans to use the drug as a preventive treatment. By Nick Paul Taylor Rocket Pharmaceuticals is set to snap up gene therapy startup Renovacor, inking an all-stock merger that will give it control of a preclinical heart disease candidate and add $38 million to its cash reserves. By Max Bayer After more than a year of a brutal biotech bear market, industry stakeholders say there are signs that the financial storm clouds may be parting. The discussion at the Fierce Biotech Summit came as private financing has rebounded in September. By Nick Paul Taylor Alzheon has released one-year data from a phase 2 study of its Alzheimer’s disease candidate ALZ-801, linking the oral beta amyloid blocker to a reduction in a marker of neuronal stress and brain injury. By Nick Paul Taylor Clover Biopharmaceuticals is pitching its first-generation adjuvanted protein vaccine as a “universal booster”—and touting antibody levels against the omicron BA.5 subvariant to make its case. By James Waldron Evotec has received almost $50 million from the U.S. government to develop monoclonal antibodies that target the bacterium Yersinia pestis—also known as the bubonic plague. By Max Bayer Jay Backstrom will take the helm of Scholar Rock in October, more than 14 months after the company's last permanent CEO hire departed. By James Waldron Johnson & Johnson’s Technology, Innovation and Janssen units have moved in together to a new R&D facility in San Francisco’s Bay Campus. The nearly 200,000 square-foot space will be home to up to 400 employees, more than doubling J&J’s presence in this R&D hot spot. By James Waldron As it continues to push its DNA-based interleukin-12 therapy through phase 2 trials, Celsion Corporation has decided now is the time for a rebrand to highlight its joint focus on immunotherapies and vaccines. By Kevin Dunleavy Multidistrict litigation is looming for several companies—including GSK, Sanofi, Pfizer, Boehringer Ingelheim and Thermo Fisher—that manufactured and marketed Zantac. The federal litigation targets five types of cancers allegedly caused by consumption of the heartburn medicine. But now, in state-side litigation, plaintiffs who used Zantac are filing lawsuits that cover other types of cancers. Improve your congress competitive intelligence and cut down costs by 50% Sponsored by: Ferma.AI, a Product of ZoomRx How a new app brings the power of CRM to a leading lab instruments provider’s field service engineers Sponsored by: Cognizant Improve patient engagement, adherence, and outcomes Sponsored by: Health Catalyst Supporting your product development programme through experience, expertise, and efficiency. 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Sponsored by: DocuSign Learn how a private health insurance company uses analytics to deliver exceptional service to its employees and members Sponsored by: Genpact This paper explores how Medical Affairs is increasingly playing a key leadership role in evidence planning and generation (part 3 in a series). Sponsored by: Blue Matter, strategic consultants in the life sciences Explore how Thermo Scientific’s Process Liquid Preparation Services can help you plan for scalable buffer preparation. Sponsored by: Thermo Fisher Scientific TwinRCTs require fewer patients and shorten trial timelines for rare neurodegenerative diseases. Sponsored by: Unlearn ZS helps life sciences companies shape the future of medicine by turning healthcare data into transformative insights. Discover the power of R&D innovation Sponsored by: ZS | |
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