FDA permits Acadia to file NDA for psychosis drug without additional trial

04/12/2013 | Fox Business · Reuters

The FDA has allowed Acadia Pharmaceuticals to submit a new drug application for pimavanserin, its experimental drug for psychosis related to Parkinson's disease, without conducting an additional late-stage trial. Data from an initial Phase III trial and supporting studies is enough to support a regulatory filing, the agency said. Acadia, however, said it still needs to carry out more studies, and may not submit the new drug application until the end of 2014.

View Full Article in:

Fox Business · Reuters

Published in Briefs:

SmartBrief Job Listings for Health Care

Job Title Company Location
Attest Health Care Advisors
Nationwide, SL_Nationwide
Biotechnology/Pharmaceutical Patent Attorney
Coats and Bennett PLLC
Cary, NC
Sr. Regulatory Specialist, Biotech Center of Expertise
BASF, The Chemical Co.
San Diego, CA
Food Lawyer
Wayzata, MN
Meridian Health Plan
Detroit, MI