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Europe’s Joint Clinical Assessment promises harmonization, but it introduces a new layer of strategic complexity that manufacturers must navigate at both EU and national levels.

Ron Wyden led 7 Democrats demanding details from Pfizer, AstraZeneca, Novo Nordisk, and Eli Lilly.

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 Priority Review for HER2-positive early breast cancer in the post-neoadjuvant setting, and a new commentary argues that AI has fundamentally changed how healthcare communicators must think about content strategy.

FDA approved GSK's Wellcovorin as the first treatment for cerebral folate deficiency caused by a rare genetic variant.

The application is based on Phase III trial data showing the drug reduced the risk of invasive disease recurrence or death.

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 consolidate into a single robust pivotal study.

Conversational AI is pushing engagers to prioritize clear, explainable guidance as patients and clinicians delegate understanding to chatbots.

In today’s Pharmaceutical Executive Daily, Vinay Prasad exits the FDA’s Center for Biologics Evaluation and Research for the second time in under a year, major deal activity including a GSK and Alfasigma licensing agreement along with Servier’s $2 billion acquisition of Day One Pharmaceuticals, and Ipsen withdraws Tazverik from the market following emerging clinical trial data.

The deal comes after Novo took legal action against Hims to prevent the company from offering compounded GLP-1 medications.

The vaccine chief briefly left the role last summer before almost immediately returning to it.

The GSK licensing deal is reportedly worth up to $690 million.

Ron Lanton, Senior Partner & Global Strategist, Lanton, Lanton & Sosa Law PLLC, notes shifting regulatory signals for Moderna’s mRNA flu vaccine review and raises broader questions about the stability of the approval pathway.

Pharma companies choosing between Salesforce and Veeva’s CRM has larger implications than many expect.