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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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Treatments for overactive bladder are not one size fits all, which is why Urovant is advancing URO-902, an injectable gene therapy that is currently being investigated in Phase IIa clinical trials.
Shares of CRISPR Therapeutics fell more than 11% on Monday as investors react negatively to the endorsement of a rival beta-thalassemia gene therapy developed by bluebird bio.
OptiNose announced positive top-line results from its Phase III ReOpen2 clinical trial testing OptiNose’s XHANCE, a fluticasone propionate nasal spray for chronic sinusitis.
BioSpace looks at several companies developing new gene therapies in the wake of the FDA recommending two of bluebird bio’s lentiviral vector gene therapies.
Versanis Bio’s data reveals the results of a pooled analysis, showing that its lead asset, bimagrumab, improves body composition in both diabetic and non-diabetic patients.
ION582 is uniquely formulated using RNA technology to provide relief to patients with Angelman syndrome, a rare disorder for which limited treatment options are available.
Ahead of a scheduled Advisory Committee meeting this week, the FDA released favorable remarks about the Pfizer-BioNTech and Moderna COVID-19 vaccines for children under the age of five.
While a handful of companies have dominated the COVID-19 vaccine market in the U.S. and Europe, a number of biotechs are continuing to develop vaccines to use as booster shots.
The approval of AMX0035, which will be marketed under the brand name Albrioza, marks the first new ALS drug approved in Canada since 2018.
Genmab’s Phase II expansion cohort of the EPCORE NHL-1 clinical trial revealed that its investigational bispecific antibody epcoritamab induced a durable response in patients with LBCL.