Legal & Regulatory

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.

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.

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.

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.

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

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.

The latest news for pharma industry insiders.

These taxes on goods—with the potential to take effect in weeks or months—will vary by country, but rates could depend on regulations, industry subsidies, and other factors.

In the fourth part of her video interview with Pharma Commerce Editor Nicholas Saraceno, Jenna Dale, director of client relations at Cencora, explains the value of FDA guidance documents for manufacturers, along with the areas of CGT development that would benefit most from standardization.

The latest news for pharma industry insiders.

Trump raises the import tax to 25% on the former—while restoring the latter to 25%—in a move that could potentially take effect on March 4.

In the second part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Jim Shehan, chair of the FDA regulatory practice at Lowenstein Sandler, discusses some of the other specific regulatory updates that drug developers be closely monitoring in the current landscape.