Legal & Regulatory

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.

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.

In the first part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Paul Levesque, CEO of Theratechnologies, outlines how US tariffs on Canadian goods have impacted the company’s operations, particularly in terms of cost and supply chain management in the US market.

In the third part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Jody Hatcher, CEO of Morris & Dickson and chair of HDA’s board of directors, comments on the steps needed to achieve Drug Supply Chain Security Act compliance.

The interchangeability designation for Yuflyma, a biosimilar to Humira, may help to improve patient access and reduce costs.

In the second part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Chris O’Dell, Turquoise Health’s SVP of market solutions, discusses the biggest challenges healthcare organizations currently face in terms of price transparency.

Respective industry and government agendas could significantly reshape the US prescription drug market.

Ensuring that essential treatments reach patients safely and efficiently is an increasing imperative in today's pharma landscape.

In the first part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Chris O’Dell, Turquoise Health’s SVP of market solutions, outlines the key provisions of the recently released executive order on healthcare price transparency.

How data-driven insights can help pharma companies balance their revenue management and innovation strategies—including resource allocation, pricing, and market access.

In the final part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Brad Stewart, BDO’s national life sciences co-leader, details the Biosecure Act, including the ways pharma companies are preparing for it, especially from a compliance standpoint.

The session provides an overview of the uninsured population, and also tackles challenges faced by patients when it comes to accessing PAPs.

The conference’s first panel offers insight on the current state of awareness among beneficiaries of the Part D cap and Medicare Prescription Payment Plan via the PAN Foundation’s latest research.

The conference’s opening session highlights the sector’s current landscape of healthcare coverage and access.

Why driving results from such strategies—amid industry disruption—will be critical to success.

In the third part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Jason C. Foster, CEO of Ori Biotech, discusses how regulatory hurdles are impacting the advancement of CGTs, along with the changes he would like to see along that front in order to accelerate patient access.

The 25% tax on various imports have gone into effect, resulting in retaliatory tariffs from the impacted nations.

In the fourth part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Geoffrey Joyce, PhD, director of health policy at the Leonard D. Schaeffer Center for Health Policy & Economics at USC, comments on health policy developments that the pharma supply chain should be aware of.

After an initial 30-day pause, the US president plans to re-enact the import taxes on the nation’s trading partners—while also doubling the 10% tariff on China.

The news comes amid the possibility that President Trump imposes a 25% tariff on pharmaceuticals, which could encourage manufacturers to begin reshoring their services.

The presidential action follows up on a 2019 final rule aimed at empowering patients and boosting competition among hospitals, group health plans, and health insurance issuers in both individual and group markets.

In the third part of her video interview with Pharma Commerce Editor Nicholas Saraceno, Laura Johnson, senior director of sales, life sciences, Loftware, discusses why the demand for supply chain transparency is continuing to gain momentum, while also explaining the role that track-and-trace initiatives are playing in that effort.

In the final part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Jim Shehan, chair of the FDA regulatory practice at Lowenstein Sandler, explains how he anticipates the evolving regulatory environment impacting the future of pharmaceutical development, especially in the context of emerging technologies like AI.