Senators are probing which products fall under Medicaid-related deal provisions and whether any “MFN” prices are meaningfully lower than current Medicaid net prices after rebates.
FDA granted Priority Review to AstraZeneca’s supplemental application for Enhertu in early-stage HER2-positive breast cancer, moving the drug closer to a potential new indication for patients at high ...
In today's Pharmaceutical Executive Daily, the FDA approves leucovorin as the first-ever treatment for an ultra-rare genetic condition called cerebral folate transport deficiency, Enhertu receives FDA ...
FDA granted a narrow indication for CFD-FOLR1, targeting impaired folate transport into the CNS that drives developmental delay, seizures, movement disorders, and autistic features in some patients.
Ron Lanton, Senior Partner & Global Strategist, Lanton, Lanton & Sosa Law PLLC, discusses FDA’s removal of the two-trial requirement marking a significant policy shift and prompting sponsors to ...
In today’s Pharmaceutical Executive Daily, Vinay Prasad exits the FDA’s Center for Biologics Evaluation and Research for the ...
In a conversation with Pharmaceutical Executive Ron Lanton, Senior Partner & Global Strategist, Lanton, Lanton & Sosa Law ...
The second exit in under a year follows controversy around CRLs for Replimune and Capricor, including criticism that mid- and ...
David Rosner, principal and global life sciences customer engagement leader at Deloitte, spoke with Pharmaceutical Executive ...
Under the terms of the agreement, Alfasigma is expected to acquire worldwide exclusive rights to develop, manufacture and commercialize linerixibat, while GSK will receive an upfront payment of $300 ...
Based on the clinical trial findings, Ipsen is withdrawing Tazverik across all indications, including both follicular lymphoma and epithelioid sarcoma, and is discontinuing all active tazemetostat ...
Conversational AI is pushing engagers to prioritize clear, explainable guidance as patients and clinicians delegate understanding to chatbots. OpenAI’s announcement of ChatGPT Health and Anthropic’s ...
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