Legal & Regulatory

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.

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.

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.

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.

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 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).

Alice Valder Curran outlines the steps manufacturers should take to better prepare for upcoming executive actions on drug pricing and market access.

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%.

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.

In the second part of his Pharma Commerce video interview, Michael Rowe, Two Labs’ senior director of DSCSA/serialization compliance services, comments on stakeholders’ overall preparedness for complying with the latest enforcement deadlines.

In the first part of his Pharma Commerce video interview, Michael Rowe, Two Labs’ senior director of DSCSA/serialization compliance services, shares his overall thoughts on this year’s DMC.

A seminar shares key observations and learnings from the first round of direct price negotiations.

IQVIA’s Doug Long offers a lay of the land, including trends and developing issues that are shaping the current market.

A session dives into the trends surrounding specialty drugs and therapies, along with providing an overview of the drug development landscape.