Legal & Regulatory

This episode of Pharma Pulse covers Novo Nordisk’s FDA win for Wegovy in MASH-related liver fibrosis, new research on a promising drug combination against resistant influenza strains, and how community pharmacies are strengthening healthcare access in underserved areas.

Amid the topsy-turvy developments in global trade, one message appears certain for pharma manufacturers: the escalating need to stockpile inventory in the US.

In the second part of his Pharma Commerce video interview, Dave Malenfant, a healthcare supply chain expert, outlines how the impact of a steep pharmaceutical import tariff varies across raw materials, components, and finished products, along with why such a policy could incentivize companies to shift production to the US.

Two Labs’ Michael Rowe assesses the industry’s level of preparation, including challenges stakeholders have encountered along the way.

The directive calls for building a six-month Strategic Active Pharmaceutical Ingredients Reserve, updating the essential medicines list, and prioritizing US-made APIs.

As pharma drug pricing debates heat up, the 340B program faces mounting challenges from outdated regulations, duplicate discounts, and limited transparency.

The new North Chicago facility, slated to open in 2027, will boost domestic production of key drug ingredients for immunology, neuroscience, and oncology therapies, reinforcing US pharmaceutical capacity amid industry reshoring and tariff concerns.

Why it’s time to act on passing key bills to boost access for millions.

The CDMO’s new services at its Hopewell, NJ facility delivers scalable, phase-appropriate production, in-house quality control, and domestic sourcing to help gene therapy developers reduce complexity, speed timelines, and ensure regulatory compliance.

This episode of Pharma Pulse explores the FDA’s new proactive quality review initiative for drug manufacturing, GSK’s $370 million mRNA patent settlement with CureVac, and upcoming discussions between industry leaders and policymakers on strengthening US pharmaceutical innovation and supply chains.

A new two-phase initiative aims to streamline facility approvals, reduce reliance on foreign pharmaceutical production, and bolster domestic supply chain resilience amid rising tariffs and reshoring investments.

In an era of increasing regulatory complexity, life sciences organizations are modernizing GxP compliance through digital tools like eQMS, cloud platforms, and automated validation, while expert validation services remain essential for aligning these technologies with real-world workflows and inspection readiness.

This episode of Pharma Pulse covers Bayer’s $2.3 billion cost-cutting overhaul, promising Phase III results for Eli Lilly’s oral GLP-1 therapy orforglipron, and a pivotal court decision clearing the way for intensified competition in the high-growth obesity and diabetes treatment market.

Meanwhile, drugmakers ramp up US manufacturing investments to navigate policy shifts and protect supply chain resilience, as the Trump administration enacted tariff rates between 10% to 50% on various trading partners early this morning.

With 14 new lawsuits filed and 132 total complaints across 40 states, Novo Nordisk is intensifying efforts to protect patients from unapproved compounded semaglutide products by targeting pharmacies, telehealth providers, and deceptive marketing practices that compromise safety, mislead consumers, and violate FDA regulations.

The letters demand US drug prices match or undercut global lows, triggering a 60-day compliance timeline, and prompting strategic responses from players in the space, including Celltrion.

Is the industry ready for the Aug. 1 deadline of when these levies go into effect?

The new deal imposes 15% tariffs on most EU exports, including pharmaceuticals.

Kevin Chinn, vice president and head of the cell & gene therapy service line at Cencora, outlines why early planning, stakeholder engagement, and innovative access strategies are key to long-term CGT success.

As new pricing and trade policies take shape, 60% of life sciences and healthcare executives anticipate business disruption, according to a new survey from Deloitte.

These innovations are revolutionizing pharmaceutical packaging by enhancing drug safety, combating counterfeiting, ensuring regulatory compliance, and improving patient adherence across the supply chain.

A timeline of key developments surrounding Sarepta Therapeutics' Duchenne muscular dystrophy drug Elevidys, and the potential future impacts for gene therapy regulation and market access.

Meanwhile, President Trump continues to push reciprocal levies and reshoring efforts, while pharma prepares for escalating costs.

In the fourth part of this roundtable discussion, a panel of subject matter experts dive into data exchange challenges relating to the Drug Supply Chain Security Act.

Pharma prepares for looming tariffs, as the US president signals a phased increase starting Aug. 1, but the official starting tax rate is yet to be determined.