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TOP STORIES
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.
IPO
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.
Biopharma professionals sometimes find themselves out of jobs when employers want to bring staff back into the office, as recently seen at biotech EMD Serono and Exelixis.
Real progress happens where unmet medical need is greatest and patient impact can be clearly measured. Pediatric rare cancers exemplify these criteria and have therefore generated continued investment, even in a capital-constrained environment.
FDA
If confirmed by the Senate, Heidi Overton—officially revealed Wednesday as President Donald Trump’s choice for FDA commissioner—is expected to be a boon for developers of psychedelic therapeutics and non-opioid pain drugs, but could tow the party line on vaccines.
PRESS RELEASES
Leading cognitive-disorders specialist, Dr. William Shankle, will discuss vascular cognitive impairment, vascular dementia and the proposed clinical trial of VesCell™ (ACP-01) today at 12:00 EST, at https://us06web.zoom.us/webinar/register/WN_nJ8ViLkRSeiU_NXMYJ-jbw
Maccabi exercises option to extend agreement for an additional year, reinforcing continued adoption of TempraMed’s medication protection technology
MARKET RESEARCH REPORTS