Legal & Regulatory

The Supreme Court invalidated IEEPA-based tariffs, but pharmaceutical tariffs imposed under Section 232 remain in effect.

In the second part of his Pharma Commerce video interview, John Stanford, Incubate’s executive director, points out how uneven Medicare negotiation timelines between small molecules and biologics are influencing R&D and venture funding decisions, according to biotech investors advocating for legislative changes.

In today’s Pharma Pulse, Johnson & Johnson commits over $1 billion to a new biomanufacturing site in Pennsylvania, while Hims & Hers enters a $1.15 billion agreement to acquire Australian telehealth leader Eucalyptus.

A policy change allowing approval of some new drugs based on one adequate and well-controlled study could accelerate development timelines, while raising questions about evidentiary standards and downstream supply chain planning.

In today’s Pharma Pulse, the FDA shifts its stance on Moderna’s mRNA flu vaccine after an initial rejection, while Eli Lilly secures a major licensing deal for a promising anti-inflammatory antibody.

In today’s Pharma Pulse, HHS Secretary RFK Jr. centralizes department operations under CMS leadership, while a new telehealth model shows a 66% reduction in repeat ER visits for older adults.

A 2026 industry survey finds mounting pressure from PBMs, federal pricing reforms, and compliance scrutiny, as manufacturers increase automation and AI investment to manage expanding gross-to-net exposure.

While the Inflation Reduction Act introduces a $2,100 out-of-pocket cap and payment smoothing options for Medicare Part D beneficiaries, low awareness and persistent health literacy gaps threaten to limit their real-world impact—highlighting the need for coordinated action across providers, pharmacies, industry, and advocacy groups.

Companies not included in the initial round are now pursuing their own agreements amid concerns over levies, Medicare pilot programs, and future price-setting policies.

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.

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.

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.