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Denali Therapeutics is the latest company to sell a priority review fast pass for an elevated price after the program was renewed earlier this year.
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While agents like AbbVie’s Humira have transformed the treatment landscape, not all patients benefit equally from the drug. Better biomarker analysis and more investment in mechanistic trials can inform the development of more effective therapies with broader clinical value.
Precision science is ruling the M&A scene as pharmas prepare for loss of exclusivity on key products, PwC says in a new report. Biotechs should be prepared with a dual-track process with the IPO window now open.
While biopharma’s overarching mission is to develop innovative medicines to improve patient outcomes, for these six people, the motivation came from much closer to home.
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FDA veteran Peter Marks will now shape the future of Eli Lilly’s vaccines work after the buys of Curevo, LimmaTech Biologics and Vaccine Company for up to $3.8 billion total.
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The payment scheme will tie gene therapy payments to improvements in health outcomes—and could potentially boost the uptake of these sickle cell disease treatments.
In recent months Novo Nordisk has invested several billions of dollars to boost its manufacturing capacity—including its highly contested $16.5 billion merger with CDMO giant Catalent.
In this episode of Denatured, BioSpace’s Head of Insights Lori Ellis, Miguel Forte and Ali Pashazadeh discuss how a slow and steady pace is a continuation of the pattern we have seen throughout the last three years.
Based on how President-elect Donald Trump’s first administration handled immigration, experts are concerned about how his second term will impact foreign-born biopharma professionals. Two immigration attorneys discuss what may be ahead, including increased difficulty getting work visas.
One year after a potential $1.7 billion deal with Hansoh Pharma, GSK goes back to China to forge another alliance with DualityBio for another deal that could be worth up to $1 billion as it continues to build up its ADC portfolio.
The Danish startup, whose lead candidate has parallels to Amgen’s MariTide, launches on the heels of Amgen’s Phase II data release for the drug last week.
President-elect Donald Trump and his incoming administration are unlikely to attempt a wholesale restructuring of U.S. healthcare and could promote M&A activity, but controversial picks like Robert F. Kennedy could impact vaccine sales, experts say.
SURMOUNT-5’s results reflect those of multiple real-world studies, which have found that tirzepatide treatment results in stronger weight loss than semaglutide.
The agency’s warning letter outlines Applied Therapeutics’ failure to provide adequate information regarding the clinical trial—including a dosing error for govorestat—claims that the company said it had already addressed.
Amylin analogs present a strong alternative or complement to GLP-1 receptor agonists, potentially eliciting higher-quality weight loss with a cleaner tolerability profile.