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As Novo Nordisk cuts 400 jobs at the troubled site, Scholar Rock has seen enough progress that it included the facility in a resubmission for FDA approval.
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Following Insmed’s decision to hold off on launching a newly approved lung disease drug in Europe, experts anticipate more companies will do the same as they seek to avoid price erosion in the U.S. Will Chinese biotechs fill the void?
The recent uptick in IPOs is an encouraging signal after a drought for much of 2025. Experts point to AI as a driving force behind this resurgence.
Deal-hungry Big Pharmas, a long-sought biotech prize, an infrequent buyer and one serial biotech rabblerouser highlight a busy quarter in biopharma M&A.
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Read our takes on the biggest stories happening in the industry.
While requests by government officials for anonymity when speaking to the media are nothing new, the practice attracts more scrutiny when the Department for Health and Human Services has pledged a commitment to “radical transparency.”
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Longevity is a long-standing buzzword in life sciences, but it now has staying power. The smart trajectory is to stop chasing aging as an abstract target and concentrate on specific mechanisms that can clearly target specific, age-related diseases, according to two investors in a discussion with BioSpace.
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.
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.