Legal & Regulatory

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.

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.

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.

Claire Riches highlights inefficiencies in the current drug approval process, while outlining the role of payers and insurers in shifting toward data-driven approval framework.

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.

Renier Brentjens, MD, PhD outlines the evolution of the space, while offering ways to boost patient access to these treatments.

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.