Legal & Regulatory

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.

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.

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.

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.

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?

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 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.

In this Q&A, Scott Brunner, CEO, and Tenille Davis, Chief Advocacy Officer, of the Alliance for Pharmacy Compounding discuss the challenges faced by patients and healthcare providers due to drug shortages, particularly for semaglutide and other medications.

With great power comes great responsibility. In this case, tackling these obstacles is vital to making sure that the positives of GLP-1s are not outweighed by the downfalls of improper waste disposal.

The now-11-year odyssey to track drugs by item through the supply chain will be under a regulatory exemption for up to two years.

A deep dive into the future of patient service programs and the value of transparency throughout the process.