Legal & Regulatory

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.

In the second part of his Pharma Commerce video interview, Philip Sclafani, PwC's pharmaceutical and life sciences lead, discusses how the pharmaceutical industry is balancing high-cost innovation, especially in obesity and metabolic disease, with payer demands for cost containment, highlighting the growing role of biosimilars and future generics in offsetting spend.

In the fourth part of her Pharma Commerce video interview, Heather Zenk, Cencora’s president of US supply chain, explores how public-private collaboration, smarter sourcing strategies, and long-term manufacturer support are helping to fortify pharmaceutical supply chains against future crises.

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.

In the third part of her Pharma Commerce video interview, Heather Zenk, Cencora’s president of US supply chain, explores how public-private collaboration, smarter sourcing strategies, and long-term manufacturer support are helping to fortify pharmaceutical supply chains against future crises.

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

In the final part of his Pharma Commerce video interview, Hyung Heon Kim, CEO of MetaVia, discusses the potential repercussions of telehealth companies selling GLP-1s.

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.

In the fifth part of this roundtable discussion, a panel of KOLs explore how the chain of custody and chain of ownership are impacted by supply chain challenges, such as last-mile distribution and DSCSA data security.

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.