Nicholas Saraceno, Senior Editor

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.

From billions in drug savings and more, we present to you today’s Pharma Pulse.

In the second part of his Pharma Commerce video interview, Dan Walles, VP & GM, traceability and compliance solutions, TraceLink, describes how initial EPCIS setup issues quickly give way to operational challenges—missing data, mismatched shipments, and suspect product alerts. Dispensers that succeed are the ones developing repeatable, cross-partner exception workflows.

The Trump administration has announced new negotiated Medicare prices for a second wave of blockbuster treatments, yielding an estimated $12 billion in savings for 2027, when compared to Medicare’s 2024 net spending.

In the first part of his Pharma Commerce video interview, Dan Walles, VP & GM, traceability and compliance solutions, TraceLink, notes that full readiness hinges on integrating serialized data exchange into everyday operations, not simply meeting minimum compliance requirements.

In today’s Pharma Pulse, the federal government prepares to unveil newly negotiated Medicare prices for 15 high-cost drugs, while Novartis receives FDA approval for Itvisma, a one-time gene therapy offering a new treatment pathway for older children and adults with spinal muscular atrophy.

As the federal government prepares to release newly negotiated Medicare drug prices, weight-loss blockbusters Ozempic and Wegovy remain in the spotlight, while CMS advances a model to cut Medicaid spending and broaden access to affordable treatments.

In the third part of his Pharma Commerce video interview, Brad Stewart, BDO’s national life sciences co-leader, explains that while the FDA has not defined the specific level of manufacturing commitment needed to improve US supply chain resilience, applicants for the voucher should focus on linking unique or rare disease therapies—particularly in areas like oncology—with domestic onshoring efforts to move their applications to the top of the pile for selection.

A new Pharma Pulse briefing unpacks declining RSV vaccine durability in older adults, AstraZeneca’s $2 billion expansion of its US biologics manufacturing footprint, and the stock-shaking Phase III struggle affecting Novo Nordisk’s Alzheimer’s ambitions.

The pharmaceutical giant will be nearly doubling biologics production in Frederick and build a new clinical supply facility in Gaithersburg, projects that will create thousands of jobs, enhance US supply chain resilience, and advance its growing rare disease portfolio.

In the final part of her Pharma Commerce video interview, Christy Christian, senior industry principal with Kinaxis, highlights a future where AI, cleaner data, and exception-based decision-making accelerate response times and strengthen end-to-end supply chain visibility.

Abbott's deal shakes up cancer diagnostics, new research confirms pandemic fatigue's impact on public compliance, and more in today’s Pharma Pulse.

In the second part of his Pharma Commerce video interview, Brad Stewart, BDO’s national life sciences co leader, reveals how National Priority Vouchers—and geopolitical pressure—are reshaping decisions around supply chain investment.

While studies reveal the complex, varying, and long-lasting burden of Long COVID symptoms, biopharma giants Novartis and Moderna commit significant capital to new facilities, reinforcing US drug supply resilience in today’s Pharma Pulse.

As part of its multi-billion-dollar investment, the company will be creating a unified, end-to-end manufacturing campus spanning biologics, gene therapy, solid dosage, and packaging operations.

In the first part of his Pharma Commerce video interview, Brad Stewart, BDO’s national life sciences co leader, explains why large-volume, high-need drugs—especially those heavily sourced overseas—may be the strongest candidates, and how the pandemic’s supply chain lessons are influencing the program’s future direction.

In today’s Pharma Pulse, we dissect the resource drain of new pilot programs, the growing concerns over global supply chain dependency, and the simple tech intervention improving glycemic control.

In final part of his Pharma Commerce video interview, Faisal Khan, a GRC solutions expert with Vanta, points out how leadership buy-in, role-based training, and “cyber moments” can reinforce continuous awareness and shared responsibility across the organization.

A US-China Economic and Security Review Commission report highlights China’s tightening grip on APIs, biomanufacturing, and R&D services, raising alarms about supply chain vulnerabilities, data transparency gaps, and the urgent need for US policy action.