After meeting with FDA, Acadia announces it needs only one pivotal study for pimavanserin. The company has canceled a second study and expects to file at the end of 2014. Faster NDA pathway could mean launch a year earlier than expected.
Acadia Pharmaceuticals Inc.’s persistence in adapting the clinical trial design for pimavanserin after an early failure in Parkinson’s disease psychosis has paid off, with assurance from FDA that the single positive Phase III trial the firm has already conducted will be sufficient for filing.
Pimavanserin (ACP-103) is a first-in-class, oral antagonist/inverse agonist of serotonin 5-HT2A receptors wholly owned by Acadia. The firm lost its...
The FDA will use electronic health records to “get eyes” on drugs immediately after approval, Commissioner Martin Makary told the DIA 2025 Global Annual Meeting. He also wants to reduce development time with better communication and new approval pathways.
The EU is testing a groundbreaking “all-in-one” process for reviewing combined drug and diagnostic trials via a single application for coordinated assessment.
The UK’s research-based pharma industry and medical research charities have set out clear action points to drive greater diversity and inclusion in clinical trials.
The whole contract research organization industry is being impacted by the current volatility in the pharmaceutical industry.
