Eisai Co. Ltd.’s Fycompa (perampanel) is only the second drug with a new mechanism of action approved for epilepsy in the last decade. Now the drug needs to find its place in clinical practice amid many treatment options, including generics.
With New Mechanism, Can Eisai’s Fycompa Make Its Mark In Epilepsy?
Efficacy results were not uniformly positive in pivotal trials of newly approved perampanel, but FDA explains that may be due to high placebo rates in some international sites.
More from Clinical Trials
• By
Experts argue that current guidelines on attributing responsibilities in clinical trials point in the right direction but lack the specificity to address the diffusion of responsibilities caused by the use of AI systems in decentralized studies.
• By
Trial sponsors in Germany should start preparing negotiation strategies to tackle difficult discussions with trial sites over standardized clauses.
• By
A new Innovative Health Initiative project will see the German health technology appraisal (HTA) body, IQWiG, work towards ensuring evidence generated in clinical studies meets the needs of HTA bodies and regulators.
• By
ILiAD Biotechnologies explains why it is confident that it will secure approval for the first-ever pivotal Phase III study using a human challenge model for a whooping cough vaccine. Also, it outlines why the UK is the preferred destination for this ground-breaking study.
More from R&D
• By
Sponsors who want to ensure their approved studies are visible to patients on the new EU clinical trials map must update their records in the Clinical Trials Information System on time and in accordance with the Clinical Trials Regulation.
• By
The FDA Commissioner nominee also commented on trial diversity, the role of public comment and expedited biosimilar reviews during his Senate confirmation hearing.
• By
During his Senate confirmation hearing, Bhattacharya also said he does not believe the MMR vaccine causes autism and emphasized transparency with NIH-funded researcher ties to the pharmaceutical industry.