Legal & Regulatory

The FDA granted accelerated approval to Boehringer Ingelheim’s Hernexeos for first-line HER2-mutant NSCLC following a 44-day review under the National Priority Voucher Program.

A guide to how the IRA is reshaping Medicare Part D, price negotiations, manufacturer liability, and pharmacy operations, along with what it means for access, adherence, and commercial strategy.

Rare disease drugs now drive innovation, investment, and portfolio strategy as policy incentives, scientific advances, and market success reshape biopharmaceutical growth.

In the final part of his Pharma Commerce video interview, John Stanford, Incubate’s executive director, argues that while Medicare price controls may reduce federal spending, they have yet to meaningfully improve patient access—contending that true reform must address insurance design, out-of-pocket costs, and the long-term impact on life sciences innovation and investment.

The FDA’s Plausible Mechanism Framework is designed to facilitate the approval of highly individualized therapies for patients with ultra-rare diseases.

In the third part of his Pharma Commerce video interview, John Stanford, Incubate’s executive director, shares how Incubate’s analysis of SEC filings reports dozens of halted research programs following the Inflation Reduction Act’s passage, while recent legislative changes tied to orphan drugs appear to be influencing renewed rare disease investment.

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.

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.

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.

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.

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.