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Trade & Channel Strategies 2025: How Regulatory & Patent Cliff Disruption is Remaking Pharma Channels

HTI-4 Standards Target Lack of Transparency in Medication Access

Pharma Pulse: Lilly’s Jaypirca Challenges Imbruvica, as AI Chatbots Could Prove Key to Boosting Vaccine Rates

Price Transparency Advances, Prior Authorization Still Stalls

How AI-Powered Precision Is Reshaping Medical Affairs
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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.

In today’s Pharma Pulse, a structured exercise program is proven to manage persistent long COVID symptoms, while Regeneron commits $150 million upfront to Tessera for a gene writing therapy targeting AATD, and Strive Pharmacy invests in a massive Arizona facility to boost national personalized medicine capacity.

The new 350,000 square-foot Mesa hub is expected to expand the compounding pharmacy’s national fulfillment and advanced compounding capabilities.

In the first part of his Pharma Commerce video interview, Colin Banas, MD, DrFirst’s chief medical officer, explains that with updated certification requirements for drug pricing transparency and electronic prior authorization, providers will see momentum build toward more efficient, patient-focused medication workflows.

In today’s Pharma Pulse, a US-UK trade agreement mandates that the UK’s NICE agency raises its QALY threshold, increasing access to innovative drugs and much more.

In the final part of his Pharma Commerce video interview, Dan Walles, VP & GM, traceability and compliance solutions, TraceLink, notes that while DSCSA was designed for compliance, its first major business value is enabling targeted recalls.

The agreement includes exemptions for UK-produced drugs and medical devices from Section 232 tariffs, but mandates a significant change to the UK's NICE value appraisal framework.













