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HDA 2025 Traceability Seminar: FDA Emphasizes Readiness Over PerfectionLatest Content

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In today’s Pharma Pulse, the University of Maryland expands its medical class to combat physician shortages and much more.

Commercialization expert Bill Roth outlines the critical need for "adaptive capacity," detailing how accelerating government regulation and massive patent cliffs are forcing a complete overhaul of commercial strategies across various markets.

In the final part of his Pharma Commerce video interview, Colin Banas, MD, DrFirst’s chief medical officer, explains how amid soaring patient and provider frustration, new HTI-4 standards are rapidly forcing change across the insurance and technology sectors to solve the current "transparency problem," making the status of a life-saving prescription as clear and actionable as tracking a takeout order.

In today’s Pharma Pulse, new trials confirm AI chatbots are a successful and sustainable tool for increasing pneumococcal vaccine uptake among older adults and much more.

In the second part of his Pharma Commerce video interview, Colin Banas, MD, DrFirst’s chief medical officer, points out that while real-time benefit tools are improving coverage visibility at the point of care, true efficiency requires actionable insights and standardized ePA, an area still “laying the tracks.”

Artificial intelligence is fundamentally transforming medical affairs from a reactive function into a strategic partner by converting disparate data into "precision medical affairs" insights, driving targeted HCP engagement and operational efficiency.

In today’s Pharma Pulse, the ACIP votes to end the decades-long universal hepatitis B birth dose recommendation; meanwhile, former FDA commissioners warn that new vaccine policies are compromising the long-standing regulatory framework and jeopardizing public health security.

The entrepreneur urges the Trump administration to eliminate costly FDA generic drug fees, part of a broader push to scale domestic production, address shortages, and challenge PBM-driven pricing models.

In the final part of his Pharma Commerce video interview, Ed Schoonveld, value and access advisor for Schoonveld Advisory and author of The Price of Global Health, previews his December column, exploring US price-referencing guidance, its impact on innovation, and whether this marks the beginning of broader pricing controls.

In today’s Pharma Pulse, Dr. Tracy Beth Høeg is named acting CDER director amidst high leadership turnover, promising modernization and transparency.

The pharma distribution giant is scaling its third-party logistics network across Europe and the United States, adding cryogenic capacity, new facilities, and enhanced cold chain services, to support rising demand for specialty pharmaceuticals and global market access.

In the second part of his Pharma Commerce video interview, Ed Schoonveld, value and access advisor for Schoonveld Advisory and author of The Price of Global Health, notes that while non-transferability could hinder smaller biotechs partnering late with pharma, most alliances are already in place before vouchers become relevant.

In today’s Pharma Pulse, Dr. Richard Pazdur retires from his CDER director role weeks after his appointment, and much more.

Analysis determines that emotional barriers, knowledge gaps, and skills deficits are far more disruptive to starting and staying on therapy than commonly perceived financial obstacles.

In the first part of his Pharma Commerce video interview, Ed Schoonveld, value and access advisor for Schoonveld Advisory and author of The Price of Global Health, explains that affordability is only one pathway to securing a voucher—and reducing list prices isn’t the only way to demonstrate value.













