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Eli Lilly and Regeneron are leading the push to treat congenital deafness with gene therapies, seeking a piece of a potential billion-dollar market and banking on local delivery and the small amount of drug required to overcome key safety concerns.
The FDA’s Commissioner’s National Priority Voucher program, unveiled in June 2025, is “shrouded in secrecy,” Democratic representative Jake Auchincloss said last month, as regulatory and biopharma leaders try to decode the criteria for investigational or approved drugs to receive a voucher.
Follow along as BioSpace tracks job cuts and restructuring initiatives.
A spokesperson for the Department of Health and Human Services refuted the claim, made Thursday on social media by ACIP Vice Chair Robert Malone, calling it “baseless speculation.”
Biotech, in particular companies that are pre-commercial with a longer-duration risk profile, could be great investments as Operation Epic Fury rolls on, according to a Truist Securities analysis.
At its peak, Imcivree’s sales in hypothalamic obesity could reach over $2 billion worldwide, according to analysts at Stifel.
Aside from the $2 billion upfront payment, Novartis is also putting up to $1 billion on the line in milestones for Synnovation Therapeutics’ pan-mutant-selective PI3Kα blocker.
The main beneficiary of Roche’s discontinuation of an investigational spinal muscular atrophy drug is Scholar Rock, which was hobbled by manufacturing concerns at a Novo Nordisk facility last year but is now nearing a potential resolution.
With the approval of Wegovy HD, Novo Nordisk joins Johnson & Johnson, Boehringer Ingelheim and USAntibiotics as beneficiaries of the FDA’s Commissioner’s National Priority Voucher program, which aims to review products that align with certain national priorities in less than two months.
The company is establishing commercial production capabilities to fuel plans to launch autologous CAR-T cell therapies in China.
Sarepta Therapeutics says the FDA has agreed to review a regulatory package for Amondys 45 and Vyondys 53 after they failed a confirmatory trial, but whether the agency will agree to approve them is still unknown.
Eli Lilly’s retatrutide could present a “differentiated option” for patients with type 2 diabetes who want to control their blood sugar and achieve maximal weight loss, according to analysts at BMO Capital Markets.