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Roche said the Phase II results help build the case for advancing CT-388 into late-stage testing, which is set to get underway this quarter.
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Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
Together with robust data-driven modeling, rethinking regulation and data use could push forward a notoriously challenging field.
From opening new therapeutic mechanisms to repairing neuronal damage, investigational molecules from Ventyx Therapeutics, AC Immune, Gain Therapeutics and more could shape the future of Parkinson’s disease treatment.
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The FDA’s rare pediatric disease priority review voucher program missed reauthorization at the last minute in 2024; advocates have been fighting to get it back ever since.
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With its lawsuit filed against Pfizer and BioNTech, the British multinational biopharma has joined the high-profile patent battle over mRNA technology used in COVID-19 vaccines.
Pfizer will go toe-to-toe with CSL Behring following the FDA’s Friday approval of its hemophilia B gene therapy Beqvez and will launch a warranty program based on the durability of response.
The genetic engineering startup, recently honored by BioSpace readers for its work environment, is downsizing as it seeks to launch its first clinical trials.
Is there a connection between Bristol Myers Squibb’s announcement that it will reduce its headcount by 6% and the company’s recent acquisitions of Karuna, Mirati and RayzeBio?
Several companies—including Roche, Curemark and Yamo Pharmaceuticals—are running clinical trials of treatments that aim to offset the myriad challenges of autism.
Sanofi is dropping its Sjögren’s syndrome candidate due to disappointing Phase II efficacy data, while AstraZeneca is stopping work on some early-stage assets amid a portfolio reprioritization.
Merck’s bestselling immunotherapy raked in $6.9 billion in the first quarter of 2024. Analysts had been expecting $6.71 billion in Keytruda sales, according to estimates from FactSet.
Regeneron will use Mammoth Biosciences’ tiny Cas enzymes to deliver in vivo CRISPR-based gene editing therapies to tissues and cell types beyond the liver, the companies announced Thursday.
Bristol Myers Squibb announced Thursday it is implementing major cost-cutting measures including thinning out its management layers. The pharma also reported modest revenue growth despite taking a 6% sales hit for lung cancer therapy Opdivo.
Sen. Bernie Sanders (I-Vt.) on Wednesday launched an investigation into the exorbitant prices of Novo Nordisk’s Ozempic and Wegovy blockbusters, and has asked the Danish drugmaker to justify their price tags.