Legal & Regulatory

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 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 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.

This episode of Pharma Pulse discusses new data showing a post-Dobbs surge in telehealth medication abortion requests, the FDA’s expedited review of Tzield under its new National Priority Voucher Program, and the launch of a dedicated biopharma air logistics network by Frontier Scientific Solutions and ATSG.

Kala Shankle, JD, HDA’s vice president of regulatory affairs, shares that as DSCSA traceability requirements take full effect, distributors and trading partners are preparing for long-term gains in supply chain security, recall efficiency, and counterfeit prevention.

This episode of Pharma Pulse covers Amazon and WeightWatchers’ partnership to deliver FDA-approved weight-loss medications, Merck’s new biomanufacturing center of excellence in Virginia, and the FDA’s first-ever approval of a TSLP-targeting biologic, Tezspire, for chronic rhinosinusitis with nasal polyps.

The company’s new 400,000-square-foot facility in Elkton will boost small molecule manufacturing, create hundreds of jobs, and strengthen US innovation and supply chain resilience.

Kala Shankle, JD, HDA’s vice president of regulatory affairs, describes how FDA officials are signaling a balanced enforcement approach when it comes to DSCSA enforcement, expecting compliance efforts and documentation, but also recognizing that perfection will take time.

Kala Shankle, JD, HDA’s vice president of regulatory affairs, details that after a year of steady progress, manufacturers and distributors report over 97% data accuracy under DSCSA traceability requirements, marking a major milestone in supply chain interoperability and signaling confidence ahead of the November compliance deadline.

The $445 million expansion of AstraZeneca’s Coppelsite will boost global production capacity for Lokelma, enhance local job growth, and strengthen the company’s US manufacturing footprint amid industry-wide onshoring trends.

Kala Shankle, JD, HDA’s vice president of regulatory affairs, describes how at this year’s seminar, attendees emphasized pragmatic approaches to achieving full compliance while anticipating upcoming FDA rules that could reshape wholesale and 3PL licensure standards across the pharma supply chain.

This episode of Pharma Pulse covers the FDA’s approval of a rapid one-minute HIV self-test, the US government’s decision to delay tariffs on pharmaceutical exports from Singapore, and CVS Pharmacy’s acquisition of more than 600 Rite Aid stores across three states to expand its community health footprint.

A planned 100% tariff on branded and patented drugs from Singapore is being postponed as US and Singapore officials explore potential exemptions.

In the third part of her Pharma Commerce video interview, Linda Malek, JD, partner at Crowell & Moring, explains how healthcare organizations can harmonize both approaches by prioritizing fairness, transparency, and adaptable systems.

In the second part of her Pharma Commerce video interview, Linda Malek, JD, partner at Crowell & Moring, notes that by bringing regulators and innovators together, regulatory sandboxes could help US healthcare organizations test and refine AI tools responsibly, which allows oversight agencies to keep pace with rapid technological change.

The fallout is impacting partners Scholar Rock and Regeneron, both of whom have pending regulatory applications tied to the facility.

The global generics maker’s new Florida site will produce more than 25 critical respiratory medicines, create over 200 jobs, and reinforce domestic manufacturing and drug security.