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The FDA has introduced models intended to accelerate rare disease drug development, but recent reversals of guidance from the agency speak to a lack of clarity in its implementation. AI can help focus this process.
European pharma companies splashed billions of dollars into the U.S. biopharma sector in a matter of days, but there are differing views on whether the activity represents the rise of a new buyer class or a quirk of timing.
Three pharma CEOs joined the $30 million compensation club in 2025 but Eli Lilly’s David Ricks exceeded his nearest peer by more than $4 million.
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The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
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The British pharma expects “meaningful” sales and earnings growth in 2024 and is upgrading its growth outlooks for 2026 and 2031, according to GSK CEO Emma Walmsley.
The U.S. Department of Health and Human Services on Thursday released new data showing that Americans pay three times more for prescription drugs than other developed countries and nearly 10 times more for insulin.
Alto Neuroscience and Fractyl Health provided further momentum to the recent spate of biotech initial public offerings, with both companies going public on Friday morning in respective $128 million and $110 million IPOs.
Kyverna Therapeutics, the fifth biotech with plans for an initial public offering this year, will use the proceeds to support the development of its anti-CD19 CAR-T therapies for autoimmune diseases.
The Centers for Medicare and Medicaid Services on Thursday sent its opening price proposals to drugmakers, which now have 30 days to either approve the offers or submit counteroffers.
Biotech companies are exploring multiple targets in the fight against neuroinflammation. Experts say these projects could yield the next breakthrough in treating Alzheimer’s disease.
The Swiss pharma on Thursday projected mid-single-digit sales growth for 2024, culling eight assets and looking to acquisitions and collaborations for de-risked assets with “significant potential.”
During a Wednesday webinar, FDA Commissioner Robert Califf said the agency is working on “systemic” changes to its advisory committee process.
Positive Phase III results for VX-548 could signal a new chapter in the fight against opioid addiction, but experts say there is still room to do better.
The first hearing on a potential injunction came the day before CMS is to release pricing proposals on 10 drugs.