Legal & Regulatory

As pharma drug pricing debates heat up, the 340B program faces mounting challenges from outdated regulations, duplicate discounts, and limited transparency.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

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.

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.

In the final part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Brad Stewart, BDO’s national life sciences co-leader, covers the operational or strategic steps that pharma executives ought to be taking now in order to mitigate risks while awaiting clarity on tariff implementation.

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.

In the second part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Brad Stewart, BDO’s national life sciences co-leader, comments on how pharma companies should prioritize reshoring strategies in response to these tariff threats, especially when infrastructure isn’t yet in place.

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

In the first part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Brad Stewart, BDO’s national life sciences co-leader, describes the immediate and long-term impacts of this potential levy on pharma imports.

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.

Why startups and life sciences companies should approach this booming sector with extreme caution.

In the final part of his Pharma Commerce video interview, Marschall Runge, MD, PhD, dean of the University of Michigan Medical School and author of The Great Healthcare Disruption, details the role that academic medical centers play in shaping Medicaid policy.

As drug development increasingly targets multiple indications, pharma companies must make strategic branding decisions—balancing regulatory requirements, market dynamics, and patient safety—to choose between single-brand or multi-brand approaches.

In the final part of his Pharma Commerce video interview, Mark Sawicki, PhD, Cryoport Systems’ president and CEO, predicts how he anticipates the model growing over the next three to five years, especially as global demand and regulatory complexities increase.

Dipanwita Das, CEO and co-founder of Sorcero, chats with Pharma Commerce to dig into the evolving drug development landscape, being regulatorily compliant, and the rapid advancements in artificial intelligence.

In the second part of his Pharma Commerce video interview, Mark Sawicki, PhD, Cryoport Systems’ president and CEO, explains how recent shifts in FDA leadership, funding constraints, and evolving CMC standards have each played a role in this process.

In the first part of this roundtable discussion, a panel of subject matter experts introduce themselves, while discussing the strategies that are most effective in ensuring resilience across the global supply chain.

In the second part of her Pharma Commerce video interview, LeAnn Boyd, Liviniti’s founder and CEO, discusses how this MFN executive order can affect players in the space that operate under a rebate-driven PBM model.

Though this specific agreement centers around aerospace and automobiles, the greater supply chain will wait and see how Trump’s import taxes impact pharmaceuticals, a sector that faces a potential 25% tax on imports.