Legal & Regulatory

In today’s Pharma Pulse, the FDA issues a rare “Refusal-to-File" for Moderna’s influenza vaccine, while new research confirms GLP-1s act as potent tools against chronic inflammation.

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.

In today’s Pharma Pulse, a telehealth giant retreats from the weight loss pill conflict, while safety-net hospitals secure a major legal victory against 340B reform.

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

In today’s Pharma Pulse, TrumpRx officially goes live, while Novo Nordisk prepares to take the oral version of Wegovy to the biggest stage in advertising.

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

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

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.

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.

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

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.

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 clears new denosumab biosimilars for osteoporosis and cancer-related bone loss, while healthcare leaders grapple with a surge in "nuclear verdicts" driven by shifting public sentiment.

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 today’s Pharma Pulse, major pharma players commit to most-favored-nation pricing, as DHL bolsters West Coast logistics for temperature-sensitive drugs.