Intercept Pharmaceuticals, Inc. hopes to have data ready during the first half of 2022 to resubmit obeticholic acid (OCA) for non-alcoholic steatohepatitis-related fibrosis following the June 2020 complete response letter. The company reached an agreement with the US Food and Drug Administration on a three-pathologist review process that will meet the requirement for central reading of scans set in a draft guidance that the FDA issued earlier this year, chief medical officer Michelle Berrey told Scrip in an interview.
NASH Updates: Intercept Moves Toward Re-Filing, Madrigal De-Risks Phase III
AASLD Briefing: While working on new biopsy reviews to address CRL, Intercept also might consider filing for approval in cirrhotic patients if REVERSE study succeeds. Plus other updates on NASH programs.
More from Clinical Trials
More from R&D
• By
The pact could be worth more than $2.6bn and adds to growing big pharma investment in the technology.
• By
Following the near-total dominance of IgG antibodies, the UK group is backing the potential of IgA and IgE-based therapies to transform cancer treatment with the purchase of US-headquartered TigaTx.
• By
Bharat Biotech is the latest entrant in India’s cell and gene therapy space, joining majors like Intas Pharma, Sun Pharma, Cipla and Dr. Reddy’s. An indigenously developed CAR-T cell therapy launched last year, what is driving growing interest and success in cell and gene therapies?