Brand & Product Security

Articles

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. 

Genentech Shares Promising Results from Phase III OCARINA II Study of Ocrevus for Elapsing, Primary Progressive Multiple Sclerosis

Data from the Phase III APPLAUSE-IgAN study showed a 38.3% reduction in proteinuria in patients treated with Fabhalta for IgA nephropathy compared to placebo. 

Novartis’ Fabhalta Shows Significant Promise in Reducing Proteinuria in Patients with IgA Nephropathy 

Phase IIa clinical trial of SPG60 for Fragile X syndrome offers hope for disease with no current FDA-approved treatment options.

Spinogenix’s Investigational New Drug Application for Novel Treatment for Fragile X Syndrome Cleared to Begin Phase II Trial

A cohort study digs into whether there is an improvement in overall survival or quality of life within five years of the FDA granting accelerated approval to oncology drugs. 

Evaluating the Long-Term Clinical Benefit of Cancer Treatments Granted Accelerated Approval

Cross-sectional study explores the impact of this monumental Supreme Court ruling. 

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