Legal & Regulatory

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.

In the first part of her Pharma Commerce video interview, LeAnn Boyd, Liviniti’s founder and CEO, outlines the most critical root causes of rising healthcare and drug costs that the MFN executive order doesn’t address.

In the third part of her Pharma Commerce video interview, Kirsten Newquist, Identiv’s CEO, shares the ways in which regulations, including DSCSA, are impacting the adoption of smarter packaging technologies across the industry.

Ron Lanton, Partner, Lanton Law, weighs in on the potential international trade, pricing, and access implications of tying US drug costs to those in other developed countries under the Most Favored Nation executive order.

In order to succeed in today’s outcomes-driven healthcare landscape, pharmaceutical companies must move from traditional sales models to strategic, measurable partnerships with integrated delivery networks (IDNs).

The designation allows pharmacists to substitute it for Humira without prescriber approval (per state law), which expands patient access in the process.

As this medical approach continues to become more widely adopted, the industry must adapt to help provide precise, compliant, temperature-controlled delivery of highly individualized treatments.

In a Q&A with Pharma Commerce, Kurt Lunkwitz, ProRx Pharma’s COO, uncovers the stringent requirements that 503B outsourcing facilities must abide by under the Drug Quality and Security Act, while also shedding light on the FDA’s impact when it comes to improving the safety, quality, and trust in compounded drugs.

In an article recently published by The New England Journal of Medicine, FDA higher-ups Vinay Prasad, MD, MPH; and Martin A. Makary, MD, MPH, wrote that any new COVID-19 vaccine must now be evaluated in placebo-controlled studies.

In an exclusive sit-down with Pharma Commerce, Anne Cassity, senior vice president of government affairs for the National Community Pharmacists Association (NCPA), discusses pending legislation that could affect the impact of PBM pricing.

Trump anticipates that the executive order will help lower drug prices by 30% to 80%.

In the final part of his Pharma Commerce video interview, Michael Rowe, Two Labs’ senior director of DSCSA/serialization compliance services, discusses the obstacles in documenting and proving DSCSA compliance.

The financial decision is due to customer demand stemming from the reshoring of drug supply services.

The President plans to sign an executive order on Monday morning to enforce the trade clause.