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Eli Lilly continues to spend its GLP-1 landfall with four new deals in the past week, including three in the vaccine space; the obesity leader also touted surgery-like results for its next-gen weight loss drug; Moderna’s stock climbs on the hantavirus “fear trade”; and in oncology, all eyes are on Revolution at ASCO this week.
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Partners Summit Therapeutics and Akeso are expected to steal the show at the American Society of Clinical Oncology’s annual conference with data from their potential Keytruda rival, alongside Revolution Medicine’s groundbreaking pancreatic cancer candidate and other assets that could reshape patient care.
The tragic tale of TIGIT is well known. However, RIPK1, myc, STING and alpha-synuclein have also left a trail of failed clinical trials, canceled partnerships and sunk investments in their wake.
Analysts homed in on Duchenne muscular dystrophy and myotonic dystrophy type 1 assets during first quarter earnings as major players like REGENXBIO and Novartis as well as Dyne, Wave, Solid and Sarepta near the regulatory finish line.
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The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
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In an SEC filing, Zymergen revealed it was cutting 80 more jobs and parting with Zach Serber, its co-founder and chief scientific officer.
Pfizer’s RSV vaccine has produced promising data with an efficacy of 85.7% in adults over 60 with a more severe form of the disease. Data in hand, Pfizer plans to head to the FDA this Fall.
This week’s Movers & Shakers includes Tessa and Adial bringing in new CEOs, while other companies strengthened their regulatory and medical teams with key appointments
Erytech Pharma is abandoning plans to submit a Biologics License Application to the FDA for Graspa in hypersensitive acute lymphoblastic leukemia.
AstraZeneca announced a series of wins in Japan with regulatory approvals for Tagrisso, Ultomiris and Lynparza, to treat non-small cell lung cancer, myasthenia gravis and breast cancer, respectively.
BioMarin’s Roctavian was granted conditional authorization in the European Union, making it the first gene therapy approved for severe hemophilia A. Now, the company is shooting for U.S. approval.
NIH researchers found that symptomatic herpes viruses were associated with neurological symptoms, but there was no evidence that herpes viruses are linked to Alzheimer’s disease.
Bay Area-based 3T Biosciences launched Thursday with a technology platform its leadership team believes can change the future of treatment for solid tumors and immune-mediated diseases.
Novartis announced Wednesday it is temporarily halting dosing in its ongoing Phase IIb VIBRANT-HD trial of branaplam in Huntington’s disease.
Sonoma Bio announced its plans to erect an 83,000-square-foot operations facility in Seattle, while Thermo Fisher opened a new viral vector manufacturing plant in Massachusetts.