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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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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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Kailera will launch a global Phase 2 study of ribupatide this year, while Hengrui will push the asset into Phase 3 in China.
The FDA recommended that REGENXBIO run a new study, treat more patients and include a placebo arm to support a resubmission for the gene therapy RGX-121.
AstraZeneca will push the pill, elecoglipron, into a comprehensive late-stage program that will test the drug as a monotherapy, as part of a combination regimen and for several indications.
As next-generation antibody-drug conjugates reshape cancer care, digital pathology and artificial intelligence are transforming how HER2 is measured. The advances aim to help clinicians identify low and ultra-low expressors, match patients to the right therapies and make more precise treatment decisions.
As the field grows rapidly, companies are luring people from other nuclear industries and tapping the expanding educational talent pipeline, but are constrained by a steep learning curve and the value of real-world experience.
The deal gets Lilly access to Orna’s in vivo CAR T technology. The biotech’s lead asset, which has yet to start clinical testing, is focused on B cell–driven autoimmune diseases.
Analysts, investors and scientists are eager for Biogen’s 2026 BIIB080 readout. Even if successful, executives warn that there are many more steps before the Alzheimer’s therapy could reach the market.
Novo Nordisk has sued Hims for allegedly violating patents protecting semaglutide, seeking potentially “hundreds of millions” in damages, John Kuckelman, the pharma’s general counsel, said. The wellness platform pulled its version of the drug just days after launching it.
The gene therapy uses an AAV vector to restore healthy levels of the alpha-galactosidase enzyme, which is rendered dysfunctional in patients with Fabry disease, leading to the toxic build-up of lipids in cells.
The FDA in July last year declined to approve UX111 for Sanfilippo syndrome, a rare neurodegenerative disorder, citing manufacturing issues. Ultragenyx Pharmaceutical resubmitted its application ten days ago, expecting a six month review time.