Legal & Regulatory

In the third part of his Pharma Commerce video interview, Franco Stevanato, CEO of Stevanato Group, shares how automatic contract adjustments tied to labor, energy, and inflation—combined with the critical role of supply reliability—allow the company to pass through limited surcharges while maintaining strong client relationships.

In the second part of his Pharma Commerce video interview, Franco Stevanato, CEO of Stevanato Group, describes how from FDA validation to dual-site redundancy and reshoring momentum, the expansion of US capacity is a competitive advantage for pharma clients navigating increasingly complex global supply chains.

The pharma giant becomes the latest manufacturer to participate in the Trump Administration’s direct-to-patient pricing platform, aligning US drug costs with European benchmarks while reinforcing its domestic manufacturing investments.

In the first part of his Pharma Commerce video interview, Franco Stevanato, CEO of Stevanato Group, explains how near-term tariff pressures are creating short-term headwinds while accelerating longer-term investment in regional manufacturing footprints—especially in the US.

In the final part of his Pharma Commerce video interview, Philip Sclafani, PwC’s pharmaceutical and life sciences lead, points out that from biosimilars and site-of-care shifts to AI, value-based reimbursement, and potential legislative action, market deflators—not simple cost shifting—will determine whether affordability improves across employer-sponsored plans, Medicaid, and Medicare.

With a planned US launch in early 2026, the approval expands treatment options following strong late-stage trial results.

Nine more companies have joined the DTC government-run website, which is set to launch sometime next year.

The South Korea–based CDMO acquires its first US manufacturing facility in Rockville, MD, expanding its global footprint and strengthening biologics capacity.

Thani Jambulingam, PhD, professor of food, pharma, and healthcare business at Saint Joseph’s University’s Erivan K. Haub School of Business, describes why uncertainty around final tariff rules is forcing manufacturers into a wait-and-see position.

In a discussion on global trade disruption, Thani Jambulingam, PhD, professor of food, pharma, and healthcare business at Saint Joseph’s University’s Erivan K. Haub School of Business, explains why pharmaceutical manufacturers must move beyond broad assumptions about tariffs and instead assess trade risk at the individual product level.

The pharmaceutical giant’s new 700,000-square-foot hub aims to onshore production of key medicines and strengthen the US drug supply chain.

Welcome to Pharma Pulse, a Pharmaceutical Commerce podcast where we bring you the latest insights shaping patient access, supply chain/logistics, data & tech, and healthcare innovation. I’m your host, and let’s get into today’s headlines.

As the FDA ends its phased exemption period for most trading partners, Two Labs’ Michael Rowe warns that DSCSA compliance is entering a far more complex era—one shaped by real-time traceability, digital record requirements, and a transition to a 12-digit NDC.

In today’s Pharma Pulse, Augmentin XR is the first drug approved under the FDA's new CNPV pilot program and much more.

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

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.

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.

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.

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.