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ProKidney axes one Phase 3 study, aims for 'expedited approval pathway' using...
ProKidney believes it will only need one Phase 3 trial to win an FDA approval for its kidney disease cell therapy, and will discontinue another to save cash. On Tuesday, the biotech said it will wind...
View ArticleDenali details accelerated approval plans; Jazz's $850M private offering
Plus, more news about Circle Pharma, Emergent, Cytokinetics, Nxera Pharma, Neurocrine Biosciences, Simcere Zaiming, TargetRx and Calliditas: Denali Therapeutics to seek accelerated approval in 2025:...
View ArticlePraxis' epilepsy drug reduces seizures by 46% in pediatric patients in Phase...
Praxis Precision Medicines released another batch of topline data from its epilepsy program on Tuesday, this time from the Phase 2 EMBOLD study investigating relutrigine in SCN2A and SCN8A...
View ArticleNovo Nordisk continues to grapple with patchy GLP-1 drug supply in Europe
All doses of Novo Nordisk’s Ozempic are expected to face “intermittent shortages” in Europe during the fourth quarter of the year, especially lower doses, supplies of which have “deteriorated,”...
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Three Dyne executives leave as company reports new Duchenne drug data
Dyne Therapeutics’ new data on its experimental Duchenne muscular dystrophy drug is being overshadowed by the departure of several top executives. The biotech announced Tuesday that its chief operating...
View ArticleEuropean Commission revokes Ocaliva's authorization ahead of FDA adcomm
Advanz Pharma on Tuesday said its liver disease treatment Ocaliva suffered a setback as the European Commission revoked its conditional marketing authorization. Ocaliva, which was available in Europe...
View ArticleDana-Farber chief Laurie Glimcher set to leave storied cancer center
After eight years, Laurie Glimcher will step down as president and CEO of the Dana-Farber Cancer Institute, Boston’s famed oncology research center. Replacing her on Oct. 1 is Benjamin Ebert, chair of...
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Pfizer and Valneva say second Lyme booster led to 'strong' responses, target...
Pfizer and Valneva said patients demonstrated “strong immune responses” after receiving a second booster dose of their experimental Lyme disease vaccine, supporting the case for annual dosing. Patients...
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Court's ruling on Illumina-Grail deal could signal a limit to European...
Illumina’s legal victory against the European Union’s antitrust enforcer won’t give the testing company back its $7.1 billion merger with Grail. But it might dampen the bloc’s more aggressive antitrust...
View ArticleResearchers seek answers as they spell out Phase 3 failure of Bayer’s...
Researchers reported Sunday that atrial fibrillation patients who received Bayer’s experimental anticoagulant were significantly more likely to experience a stroke or systemic embolism compared to...
View ArticleBioAge files for IPO, riding momentum for weight loss drugs
BioAge Labs is heading to Wall Street after months of speculation that the Eli Lilly-partnered cardiometabolic biotech was planning to join the public markets. The company’s investor prospectus...
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Athira’s small molecule drug for Alzheimer’s fails in mid-stage study
A daily injection intended to protect and regenerate brain cells has failed to slow the progression of Alzheimer’s disease in a Phase 2/3 clinical trial run by Athira Pharma, the company announced...
View ArticleCell therapy startup ArsenalBio raises $325M as it runs early solid tumor trials
CAR-T cell therapy startup Arsenal Biosciences has reeled in a $325 million Series C as it works through two early-stage trials in solid tumors. But even after securing the fifth-largest private...
View ArticleRoche unveils more mid-stage data for BTK inhibitor in relapsing multiple...
Roche touted new Phase 2 data for its BTK inhibitor fenebrutinib in relapsing multiple sclerosis, noting that patients on the drug maintained low levels of disease activity and no progression of the...
View ArticleLilly inks obesity deal with seed-stage RNA startup as its genetic medicines...
Eli Lilly is pairing up with a so-called “dark genome” biotech startup to hunt for a new generation of obesity and metabolic drugs. The Indianapolis-based drugmaker is betting up to $1 billion on...
View ArticleTransplant biotech eGenesis snags $191M after first use of gene-edited pig...
Following a world-first transplant earlier this year, eGenesis has raised $191 million to continue developing genetically modified pig organs for people in dire need of a transplant. The biotech said...
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Little-known startup, backed by Foresite and Samsara, swings $60M China I&I deal
A new, still-in-stealth biotech is paying eight figures to acquire the rights to an experimental I&I drug out of China. Vignette Bio — a company backed by Foresite Capital and Samsara BioCapital,...
View ArticleVaxcyte aims to raise $1B after sharing pneumococcal vaccine data; More...
Plus, news about Anthos, Ascendis, Royalty Pharma, Semnur, Sonoma, Atara, Feldan, Indivior, Aelis Farma and Acepodia: Vaxcyte launches $1B offering: The raise comes fresh off the company’s pneumococcal...
View ArticleNovartis expands radioligand therapy manufacturing in California and...
Novartis is putting $200 million into its radioligand therapy manufacturing capabilities with a new site in California and the expansion of an existing site in Indianapolis. The Indianapolis site will...
View ArticleCourt orders J&J to pay $1B following buyout of surgical robotics company
Johnson & Johnson paid $3.4 billion upfront for the surgical robotics company Auris Health in 2019, with the potential for $2.35 billion more in commercial and regulatory milestones. But a Delaware...
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