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Three fatalities occurring recently in China clinical trials have spurred two members of U.S. Congress to urge the FDA to enact new policies designed to protect American patients.
The merger, which would create a new company bearing Ambros’ name, will help support development of Ambros’ non-opioid painkiller for patients with debilitating limb injuries.
The Phase 3 study is evaluating two doses of Novo’s Wegovy pill in people with obesity or overweight in combination with a reduced-calorie diet and increased physical activity.
After committing $2 billion to a new North Carolina facility to boost capacity for its next-gen obesity candidates, Roche’s Genentech is putting down more cash to expand a device fill-finish site in Oregon.
Scribe Therapeutics’ one-time epigenetic treatment is designed to slash the adherence burden of chronic cholesterol-lowering therapies while sidestepping the irreversibility of gene editing.
Regeneron’s Pasatru is the second fibrodysplasia ossificans progressiva drug approved in the U.S., following the 2023 approval of Ipsen’s Sohonos.
The accelerated greenlight for Ultragenyx’s gene therapy for glycogen storage disease has raised analyst expectations for approval of UX111, which the FDA rejected last summer and is currently reviewing for a second time. A decision is expected by mid-September.
Investors had been pessimistic about the probability of success for the personalized cancer vaccine intismeran autogene, so the Phase 3 win was a welcome surprise.
In this episode of Denatured, you’ll hear from Ian McGowan, Chief Medical Officer at Synklino and James Hunter, associate professor of transplantation at Oxford University. We explore transplantation and antiviral innovation and why CMV remains one of the most persistent and consequential challenges facing transplant patients today.
Workforce cuts this year at seven companies involved in recent mergers and acquisitions will cost over 1,300 employees their jobs. Affected businesses include Arcellx and Tourmaline Bio, acquired by Gilead Sciences and Novartis, respectively.