Legal & Regulatory

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

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 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 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.

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.

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.

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.

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.

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.

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.

This episode of Pharma Pulse discusses how the FDA’s new plausible mechanism pathway, WeightWatchers’ plans to offer oral Wegovy, and emerging evidence on berberine are shaping the future of obesity and metabolic health care.

In the first part of her Pharma Commerce video interview, Christy Christian, senior industry principal with Kinaxis, describes how manufacturers face mounting challenges managing long, complex supply chains, including limited inventory buffers, tight cash flow constraints, and constant policy changes.

This episode of Pharma Pulse discusses FDA’s growing National Priority Voucher initiative, fresh data on oral semaglutide’s cardiometabolic impact, and Mark Cuban’s latest drug addition that signals key shifts in innovation, access, and affordability across the pharmaceutical landscape.

Nine drugs from leading manufacturers will participate in HRSA’s new 340B rebate model pilot program, set to begin in 2026, which aims to evaluate a rebate-based framework for future drug pricing models amid ongoing industry litigation.

This episode of Pharma Pulse discusses Novartis’ $12 billion acquisition of Avidity Biosciences to expand its RNA therapeutics portfolio, and President Trump’s proposed 10% tariff increase on Canadian imports that could disrupt pharma supply chains.

The move adds new tension to US-Canada trade relations under the USMCA and raises questions about pending pharmaceutical import policies.