Legal & Regulatory

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?

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.

Getting a handle on level of compliance-readiness for the Drug Supply Chain Security Act deadline—now just weeks away.

Webinar Date/Time: Tue, Oct 22, 2024 11:00 AM EDT

As the dust settles on the first round of Medicare negotiations, not everything is what it seems.

The session details how these teachings span the entire pharma supply chain.

A panel offers its perspective on bolstering the temperature monitoring and data sharing process.

With the Nov. 27 deadline fast approaching, is the pharma supply chain ready for full data exchange?

Bimzelx is the first approved medication for active psoriatic arthritis, non-radiographic axial spondyloarthritis, and ankylosing spondylitis that selectively inhibits IL-17A and IL-17F, both of which are key cytokines that drive inflammatory processes.

Accord BioPharma's 420 mg strength Hercessi (trastuzumab-strf), a biosimilar to Herceptin, gains FDA approval to treat HER2-overexpressing breast cancer and gastric cancer.

FDA fast tracks Sun Pharma and Moebius Medical’s MM-II treatment for osteoarthritis knee pain, with Phase III clinical trials planned to expedite a potential approval.

It’s essential for commercial success, but presents its share of obstacles.

A cross-sectional study investigates changes in Medicare Advantage enrollment among Medicare beneficiaries with end-stage renal disease in the first two years of the Act.

In the final part of her interview with Pharma Commerce Editor Nicholas Saraceno, Elizabeth A. Gallenagh, General Counsel and Senior Vice President, Supply Chain Integrity, Healthcare Distribution Alliance, discusses the WEE request process itself, while also providing her thoughts on other sessions that have garnered her attention.

In an interview with Pharma Commerce Editor Nicholas Saraceno, Elizabeth A. Gallenagh, General Counsel and Senior Vice President, Supply Chain Integrity, Healthcare Distribution Alliance, highlights the hard-hitting points that she anticipated will be covered during her session at the 2024 HDA Traceability Seminar.

In the final part of her interview with Pharma Commerce Editor Nicholas Saraceno, Ilisa B.G. Bernstein, President of Bernstein Rx Solutions, LLC, comments on industry’s preparedness for DSCSA compliance and provides an update as to where pharma is in terms of RFID label adoption.

In the second part of her interview with Pharma Commerce Editor Nicholas Saraceno, Ilisa B.G. Bernstein, President of Bernstein Rx Solutions, LLC, discusses the best practices that compliance teams should consider as the end of the stabilization period approaches this November.

In an interview with Pharma Commerce Editor Nicholas Saraceno, Ilisa B.G. Bernstein, President of Bernstein Rx Solutions, LLC, highlights the hard-hitting points that she anticipated will be covered during her session at the 2024 HDA Traceability Seminar.