Legal & Regulatory

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.

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.

In an interview with Pharma Commerce Editor Nicholas Saraceno, Michael Rowe, Two Labs’ Senior Director of DSCSA/Serialization Compliance Services, offers a brief overview of the Drug Supply Chain Security Act.

Why they are a game changer, and ways to a adapt to a new era of state privacy regulations.

With the standard constantly evolving across the pharma sector, the latest version can help bring benefits to the regulatory process.

If Congress doesn't act soon, it could result in more health inequities.

These advancements continue to act as a key driver in helping to boost the security, efficiency, and innovation of global industries, include pharma.

In an interview with Pharma Commerce Associate Editor Don Tracy, Ron Lanton, Partner, Lanton Law offers his thoughts on the recent Federal Trade Commission (FTC) repeal of non-compete agreements, and how it could effect the pharma industry.

Study explores how the Inflation Reduction Act’s Drug Price Negotiation Program and its maximum fair prices impact incentives for investments in post-approval activity.

The partnership revolves around augmenting regulatory compliance, along with drug sampling distribution and compliance.

Citing a need for more Chemistry Manufacturing and Controls information, Abeona intends to address the requirements quickly.

Approval comes amid positive results of a single-arm trial, showing a complete response rate of 77% in patients with Bacillus Calmette-Guérin-unresponsive non-muscle invasive bladder cancer.