article thumbnail

Sandoz to file for approval of aflibercept biosimilar

European Pharmaceutical Review

The confirmatory efficacy and safety study ( NCT04864834 ) demonstrated therapeutic equivalence between the biosimilar aflibercept and the reference biologic, Eylea®. Safety, immunogenicity, and pharmacokinetics results also confirmed no clinically meaningful difference between the products.

Safety 98
article thumbnail

Securing every dose with an edible security technology for safe medicines

European Pharmaceutical Review

FAKE MEDICINES are not a new problem, and pose a tremendous threat to patient safety and public health in society regardless of a country’s economic status. World Health Organization; 2006. The prevalence of fake drugs is a continually growing problem worldwide. References. Counterfeit medicines. Available from: [link]. The Guardian.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

Learning from lecanemab: a breakthrough treatment

European Pharmaceutical Review

In clinical trials, we targeted the early AD population with confirmed amyloid in the brain and found the right optimal dose that balanced efficacy and safety in the large Phase II dose-ranging study. Building on these 4R’s, we designed the Phase III Clarity AD study in order to definitively assess the safety and efficacy of lecanemab.

article thumbnail

RFID: The future of smart labelling?

Pharmaceutical Technology

Pfizer was the first to use the tech, adding RFID tags to track a Viagra (sildenafil) shipment circa 2006. Various uses soon became apparent including those for supply chain management, anti-counterfeiting, and to improve patient safety.

article thumbnail

Gene therapy: a radical pharmaceutical revolution

European Pharmaceutical Review

Considerable progress has been made in other areas including enhancing safety, improving treatment administration and patient monitoring systems and implementing innovative pricing strategies – all with the goal of providing timely access to eligible patients who can benefit from these treatments. 1995; 270(5235): 475-480. cited 2023August].

article thumbnail

HIV vaccines suffer setbacks but new approaches could turn the tide

Pharmaceutical Technology

A partial change in perspectives The RV144 trial that took place between 2003 and 2006 in Thailand r eported modest efficacy results , which generated enthusiasm for vaccines that induce responses from non-neutralising antibodies, says Montefiori. The third cohort features the highest studied dose.

Medicine 117
article thumbnail

The Evolution of Biosimilars from Their Beginning Until Now—And What’s Next

PM360

Chrys Kokino has been involved in the biosimilars market prior to the first biosimilar being approved in Europe in 2006. The entire premise was that because biosimilars were so new, and there was not a lot of information on the safety and efficacy of those products, customers should be a bit leery prior to jumping on the biosimilar bandwagon.