Legal & Regulatory

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.

Donald Prentiss discusses the value of these pharmacies, especially during shortages.

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.

In the final part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Joe Lipari, director of product management, Systech, predicts the probability that these DSCSA compliance deadlines put forth by the FDA will be met.

The importance of embracing universal values and business models that prioritize humanity.

Addressing the bottlenecks in cell and gene therapy manufacturing through a well-designed artificial intelligence approach is essential to avoiding data siloes.

Is the potential of a more formal policy integration for health issues and disease prevention a scary suggestion or a good idea?

In the second part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Joe Lipari, director of product management, Systech, comments on what the repercussions are for failing to comply with the DSCSA.

In the first part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Joe Lipari, director of product management, Systech, describes the latest state of DSCSA implementation guidelines.

Nicholas Saraceno offers an overview of the legislation and how it impacts the pharma supply chain.

The proposal aims to reduce out-of-pocket costs for a number of weight loss medications by 95%.

Why well-organized documentation is critical at every stage of the process.

In the first part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Gaurav Gupta, managing director and head of R&D at Kotter, details the types of regulatory pressures and factors surrounding rising R&D costs that will affect the pharmaceutical industry.

In the first part of this roundtable discussion, a panel of subject matter experts introduce themselves, while discussing why the pharma supply chain sees value in this technology and why its use has fluctuated over the past decade.

In the quest for achieving full traceability, the exemption applies to certain trading partners under the Act, and postpones enforcement of final compliance requirements while acknowledging progress and ongoing challenges.