Legal & Regulatory

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.

Panel offers suggestions on how compliance teams should be considering handling SOPs, stabilization, and much more.

In an interview with Pharma Commerce Editor Nicholas Saraceno, Jeb Hunter, Senior Regulatory Consultant, EAS Consulting Group, discusses the on “What to Expect When They’re Inspecting: FDA Inspections on DSCSA Compliance" breakout session at the 2024 HDA Traceability Seminar.

Session uncovers distributors’ experiences with the Waiver, Exception, or Exemption request process, and how these affect the overall supply chain.

The agency provides an update surrounding the Act’s implementation efforts.

The updated COVID vaccine replaces previous bivalent vaccines, focusing on a single strain for more effective immunity.

By 2026, the first 10 drugs for individuals with Part D coverage—whose medications are mainly used to treat cancer, diabetes, and heart disease—will see discounts off of list prices ranging from 38-79%.

In the final part of his Pharma Commerce video interview, Michael Rowe, Two Labs’ Senior Director of DSCSA/Serialization Compliance Services, comments on other ways to limit ‘bad actors’ attempts to sneak counterfeit drugs into the supply chain, aside from the DSCSA.

In this part of his Pharma Commerce video interview, Michael Rowe, Two Labs’ Senior Director of DSCSA/Serialization Compliance Services, predicts the likelihood of stabilization period postponement.

What does the legislation mean for patient access leaders, pharma brand managers, and patient service owners? Industry experts weigh in.

Will the looming changes address the concerns of the patient assistance community?

In this part of his Pharma Commerce video interview, Michael Rowe, Two Labs’ Senior Director of DSCSA/Serialization Compliance Services, discusses the state of affairs surrounding the Drug Supply Chain Security Act, along with opportunities for improvement.