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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.

The drug is part of the Commissioner’s National Priority Review Voucher program.

FDA informed uniQure it will not accept external control data as the primary basis for approving AMT-130, instead demanding a prospective, randomized, sham surgery-controlled trial before moving forward.

Market access strategies are evolving as more biopharma companies commercialize their own therapies, requiring closer alignment with payer requirements, provider education, specialty pharmacy networks, and patient support services to ensure appropriate coverage, prescribing, and long-term adherence.

In the second part of his conversation with Pharmaceutical Executive, Ajna Biosciences CEO Joel Stanley explains the complexities of getting a botanical drug approved.

From data risk to relationship equity, the need to rethink consent in life sciences marketing.

The business and market models drugmakers must continually adapt to stay competitive as 2026 progresses.

In today’s Pharmaceutical Executive Daily, Cognito Therapeutics and Nexcure secure new financing rounds to advance their pipelines, artificial intelligence and large language models reshape pharmacovigilance and drug safety monitoring, and Eli Lilly launches a new Employer Connect platform to expand obesity treatment coverage options.

Large language models and natural language processing are reshaping drug safety surveillance by enabling automated adverse event detection, large-scale analysis of regulatory labeling data, and faster, citation-grounded safety assessments while maintaining human oversight and regulatory compliance.

Eli Lilly launches Employer Connect, a new platform linking employers with benefit administrators and a pharmacy network to expand affordable access to its obesity medication Zepbound for U.S. workers.

By correlating behavior data with performance outcomes, it becomes possible to predict what actually drives results.

Alice Valdur Curran discusses how the industry continues to strategize around this complicated order.