Brand & Product Security

Articles

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


The Need to Make Telehealth Flexibilities Permanent

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

The Impact of Serialization Technology: Ensuring Product Integrity and Regulatory Compliance

Videos

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. 

Effects of the Federal Trade Commission's Repeal of Non-Compete Agreements on 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.

A Look at the Effects of the Inflation Reduction Act 

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

Kenco, QPharma Collaborate on Improving Supply Chain Challenges

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

FDA Issues Complete Response Letter to Abeona Therapeutics Regarding PZ-Cel for Recessive Dystrophic Epidermolysis Bullosa

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. 

FDA Approves ImmunityBio’s Anktiva for the Treatment of BCG-Unresponsive Non-Muscle Invasive Bladder Cancer

Technology designed to effectively address blood clots by combining capabilities of larger devices with smaller catheters. 

Expanse Ice Receives FDA 510(k) Clearance for ICE Aspiration System for Peripheral Arterial, Venous Systems

Approval was based on positive data from Takeda’s Phase III VISIBLE 2 study, which displayed long-term clinical remission in approximately half of patients with Crohn disease receiving Entyvio. 

FDA Approves Takeda’s Subcutaneous Form of Entyvio as a Maintenance Therapy in Adults with Moderately to Severe Crohn Disease 

Data displayed rapid and sustained B-cell depletion, with 97.2% of study patients with relapsing and primary progressive multiple sclerosis experiencing no relapses. 

Legal & Regulatory