Legal & Regulatory

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.

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.

In the first part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Jim Shehan, chair of the FDA regulatory practice at Lowenstein Sandler, describes what the approach of pharma companies should be amid the latest/pending tariffs imposed on Canada, Mexico, and China, along with their potential impact on the pharma supply chain.

A study explores dual-enrollment in these plans—compared to other Medicare Advantage plans— impacts North Carolina’s Medicaid fee-for-service spending.

Known as AVT05, the Alvotech medication is a proposed biosimilar to Simponi, prescribed to treat various inflammatory conditions.

A cross-sectional study investigates the impact of Dobbs v Jackson’s Women’s Health Organization on national support and personal interest.

The latest AARP report concludes that plan members who hit this amount are expected to see savings, even when premiums are considered.

In the third part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Donald Prentiss, founder and CEO, Qualthera, explains how collaboration between compounding pharmacies, drug manufacturers, and telehealth platforms can drive success, despite the various litigations pertaining to GLP-1s that are currently taking place.

These medications are used to treat a multitude of conditions including type 2 diabetes, cancer and asthma.

The program intends to address supply chain challenges surrounding product safety, traceability, and counterfeiting.

In the final part of this roundtable discussion, a panel of subject matter experts discuss what the future holds for this technology, why end-to-end visibility is necessary in healthcare, and the opportunities for greater RFID adoption that lie ahead.

A forum intended for HCPs, policy experts, and industry leaders addresses pressing obstacles facing this sector of the industry today.

The Drug Supply Chain Security Act was a major coverage area for Pharma Commerce in 2024.

A session investigates the drivers of these shortages and ways to mitigate them.

Because of the potential for product shortages at pharmacies, the FDA has not only given industry more time for compliance—but time to catch up on boosting the supply chain’s interoperable efforts.

A cohort study of cancer drugs analyzes where the priorities of pricing policies should lie.