Legal & Regulatory

Rising recalls, tighter FDA enforcement, global supply chain dependencies, and rapid technology shifts are reshaping pharmaceutical quality and compliance—forcing manufacturers to rethink oversight, resilience, and continuous improvement across operations.

As policy pressure, tariffs, and supply chain risks push drugmakers to expand US-based production, this FAQ explains what pharma reshoring is, why it’s accelerating, which companies are investing, and how the shift could reshape reliability, regulation, and patient access.

TrumpRx is meant to reduce drug costs, but Americans are wondering how it works and what impact it will have.

What 2025 means for the life sciences sector in the New Year.

In today’s Pharma Pulse, the FTC secures a multi-billion-dollar settlement against the "rebate trap," while Congress provides long-term certainty for the digital health revolution.

Policy shifts bring meaningful improvements for some—but looming coverage losses and rising premiums threaten to erase those gains.

In today’s Pharma Pulse, AstraZeneca faces a complete response letter for its self-injectable lupus drug, while the EMA gives the green light to a historic wave of new therapies for MASH, rare diseases, and postmenopause.

The acquisition strengthens M&D’s specialty portfolio, broadens access to plasma-derived therapies, and supports phased integration focused on regulatory compliance.

Even the threat of Greenland-related tariffs rattled drug supply chains and uncovered industry vulnerabilities to instability.

In today’s Pharma Pulse, the United States finalizes its departure from global health oversight, while domestic providers face a record-breaking surge in respiratory hospitalizations.

The agency will evaluate FISP after early results show major gains in speed, capacity, and real-time risk mitigation across US ports of entry.

Artificial intelligence is helping pharma teams uncover critical safety signals faster, lower costs, and shift pharmacovigilance from compliance to competitive advantage.

In today’s Pharma Pulse, Congress races to secure funding, while Novavax nets a half-billion-dollar validation of its non-aluminum vaccine technology.

In today’s Pharma Pulse, the FDA and EMA synchronize on AI standards, a potential divide in pricing strategy occurs, and BoomRx launches a needle-free nanoemulsion for weight loss.

The company brings its temperature-controlled Superbox to the US pharma industry, aiming to improve speed, compliance, and resilience in the cold chain process.

In today’s Pharma Pulse, AbbVie joins TrumpRx, shingles vaccines reveal a longevity boost, and HER2 therapies break new ground in cancer treatment.

The company will participate in the Trump administration’s direct-to-patient drug platform, while committing $100 billion to US R&D and manufacturing.

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.

In today’s Pharma Pulse, Johnson & Johnson secures a major tariff deal by joining the federal drug discount portal, while new data warns that missing early infant shots is the leading predictor of skipped MMR vaccines.

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.

In today’s Pharma Pulse, the FDA issues two high-stakes priority vouchers for cholesterol and cancer therapies, GSK leverages genomic data to refine drug targets, and DHL completes a one-million-square-foot logistics center of excellence.

In today’s Pharma Pulse, federal officials slash the childhood immunization schedule, new data underscores the life-saving impact of COVID vaccines for COPD patients, and Eli Lilly targets the AMPK pathway in a massive new oral obesity collaboration.