Legal & Regulatory

Post-approval changes are overwhelming pharma ops teams. Here's why lifecycle change management has become one of the industry's most consequential and overlooked operational risks.

Pharma companies could face 100% tariffs under new US rules, with relief available for those prioritizing onshore manufacturing or pricing concessions.

Eli Lilly’s newest GLP-1, Foundayo (orforglipron), is the first FDA-approved weight loss pill that can be taken without food or water restrictions.

How the zero-prefix collision will disrupt reimbursement, patient access, brand protection and market intelligence — and what commercial leaders must do before 2033.

Corey Ford, principal at Nuvera, explains how pharma is shifting focus from HCPs to patients in support programs and commercialization.

The FDA launched AEMS, a unified platform that replaces fragmented legacy databases to enable real-time adverse event reporting.

The FDA is working with states to implement the Section 804 Importation Program, offering new regulatory enhancements for projecting cost savings on Canadian drug imports.

The FDA has transitioned to a "new era" of proactive enforcement, issuing warning letters to telehealth and pharmaceutical companies to eliminate misleading promotional claims and ensure a fair balance of risks and benefits regarding approved and compounded GLP-1 medications.

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.

In today’s Pharma Pulse, the FDA unveils a Plausible Mechanism framework to fast-track ultra-rare disease therapies, while Astellas partners with Vir Biotechnology in a massive $2.1 billion oncology collaboration.

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.

In today’s Pharma Pulse, BioNTech escalates its patent battle against Moderna over next-gen COVID shots, while a new pharmacist-led "PRIME" program proves a game-changer for prediabetes prevention.

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.

In today’s Pharma Pulse, the Senate tackles the regulatory red tape driving physician burnout, while Edwards Lifesciences ends its anti-copycat policy to settle European Commission antitrust concerns.

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.