Takeda Is Waking Up the Narcolepsy Market With First-in-Class Drug, But Alkermes Is on Its Heels

Takeda Pharmaceutical’s oveporexton is designed to treat the root cause of narcolepsy. Statistically significant Phase 3 results for the twice daily pill were presented Monday during the World Sleep 2025 Congress in Singapore. The post Takeda Is Waking Up the Narcolepsy Market With First-in-Class Drug, But Alkermes Is on Its Heels appeared first on MedCity…

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Estados rojos y azules buscan limitar el uso de la inteligencia artificial en seguros de salud. Trump quiere lo opuesto

¿Cómo deben usar la inteligencia artificial (IA) las aseguradoras de salud? La respuesta a esta pregunta inusual de política pública, encuentra en un mismo bando al gobernador republicano Ron DeSantis, de Florida, y al gobierno demócrata de Maryland, los dos contra el presidente Donald Trump y el gobernador de California, Gavin Newsom. La regulación de…

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FDA Qualifies First AI Drug Development Tool in MASH.No impact of Medicaid on crime rates.“The life of an artist is…”Elasticity of disability insurance (DI) takeup to DI generosity: 1.26Do it anyway.

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Carving a Path Toward Pragmatic Innovation in Clinical Trials

Prioritizing risk-based management, data science, smart automation, standards, and patient optionality are critical for the industry to keep up with market changes. The recent FDA guidance that encourages ‘pragmatic trials’ in specific scenarios is a move in the right direction. The post Carving a Path Toward Pragmatic Innovation in Clinical Trials appeared first on MedCity…

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FDA Rejection Delays Regeneron From Competing With J&J, Pfizer in Multiple Myeloma

Regeneron Pharmaceuticals said the FDA cited no approvability concerns for its multiple myeloma drug, linvoseltamab, other than previously identified issues with a contract manufacturer. While linvoseltamab trails bispecific antibodies currently marketed by Johnson & Johnson and Pfizer, if approved, it could bring patients an earlier treatment option. The post FDA Rejection Delays Regeneron From Competing…

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Moving Beyond the Mega-Factory: Why the Future of Biomanufacturing is Agile, Distributed, and Resilient

Personalized and highly-targeted therapeutics are becoming more common, making local or regional production increasingly valuable for faster patient access. This underscores how a hybrid network combining large, centralized plants coupled with flexible regional sites will define the next era of resilient biomanufacturing. The post Moving Beyond the Mega-Factory: Why the Future of Biomanufacturing is Agile,…

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