Legal & Regulatory

Domestic manufacturing can reduce certain dependencies, but reliable pharmaceutical commercialization requires qualified redundancy, sustainable economics, quality maturity and decision-ready visibility across the full supply network.

Four pharma commerce experts revisit their 2026 predictions on dealmaking, patient access and commercialization at the year's midpoint.

Gifthealth's Chip Parkinson says direct-to-patient adoption has accelerated since January, driven by structural, not cyclical, market forces.

Shortages of antibiotics, IV fluids and sterile injectables are hardening as new EU and US rules push pharma to fix the incentives behind them.

Amy Niles of the Patient Advocate Foundation on Medicaid work requirements, ACA subsidy expiration and patient affordability in 2026.

Novo Nordisk’s complaint argues that Lilly's campaigns leave out information about the most effective injectable doses of Wegovy (semaglutide) and Ozempic (semaglutide), a dispute that could reshape how both companies compete for share in the GLP-1 market.

Eli Lilly's acquisition of AtaiBeckley signals growing pharmaceutical industry commitment to psychedelic-based treatments for treatment-resistant depression.

The API Innovation Center's Gerren McHam on China's new supply chain rules, reshoring policy, and where US drug manufacturing goes next.

Germany's new health insurance law more than doubles mandatory drug rebates. Here is why it matters for US pharma pricing and launches.

As China tightens supply chain rules, tariff pressure persists, and the FDA's PreCheck Program takes shape, this FAQ breaks down how pharma reshoring stands in 2026.

Trutakna's FDA approval for IgAN highlights how patient support programs like TRU SUPPORT coordinate access and adoption in specialty drug launches.

The FDA selected seven companies, including two CGT manufacturers, for its PreCheck Pilot to accelerate domestic manufacturing approvals and bolster supply chain resilience.

A US Section 301 probe into Germany's drug pricing could bring tariffs on APIs and finished drugs, raising new supply chain and pricing risks.

CMS' proposed framework for 2029 and beyond closes a potential formulation loophole and raises the stakes for launch planning.

A new CMS demonstration launching July 1 will offer eligible Part D beneficiaries access to branded obesity drugs at a $50 copay. Here's what manufacturers, payers, and pharmacies need to know.

Erez Israeli explains how Dr. Reddy's approached commercial readiness for its generic semaglutide launch in Canada and what vertical integration in peptide manufacturing means for the GLP-1 market.

FDA approves Shionogi's Xocova, the first oral post-exposure COVID-19 prevention therapy, reducing infection risk by 67% in Phase III trials.

In this week's Pharma Pulse, the Trump administration expands TrumpRx to over 600 generics, the Supreme Court clears the way for long-term Medicare drug price negotiations, Eli Lilly moves deeper into genetic medicines with a $202 million acquisition, and the FDA loses more top leadership.

The Supreme Court declined pharma appeals, letting Medicare drug price negotiations under the IRA proceed, solidifying federal pricing authority.

In today’s Pharma Pulse, FDA leadership changes with Makary’s resignation, Lilly shares new Zepbound and GLP-1 data, and new study data on prior authorization reform outlook.

US pharma supply chains are shifting amid regulation and geopolitics, with BIOSECURE driving less Asia reliance and more complex, distributed networks.

FDA commissioner Marty Makary is planning to resign today, according to sources close to the White House.

According to the Wall Street Journal, a source close to the White House said FDA commissioner Marty Makary "is done."

For drugs already on the market, there may be little companies can do to limit business impact; however, for new development drugs, there are some critical considerations.

In this week's Pharma Pulse, Eli Lilly opens its new genetic medicine plant, Bayer acquires Perfuse Therapeutics, and more.