ICPT Message Board Post 13242712 | Intercept...
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simzy1000
(investorshub)
Posted on: May/19/2023 22:10:05
Source: investorshub
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=171951874
Ocaliva is the classic example of a drug
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sNDA intended to satisfy post-marketing requirements to confirm a clinical benefit in patients with PBC Precedent-setting submission includes data from post-marketing studies COBALT and Study 401 as well as real-world evidence from a claims database and patient registries FDA has assign...
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Monday, Gilead Sciences Inc (NASDAQ:GILD) agreed to acquire CymaBay Therapeutics Inc (NASDAQ:CBAY) for $32.50 per share i...
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Data from two Phase 2 studies in PBC show combination of OCA + bezafibrate achieved biochemical remission (normalization of ALP, total bilirubin, GGT, ALT and AST) in 40-44% of patients in the first 12 weeks OCA 5 or 5-10 mg + bezafibrate 400 mg cohorts in both studies showed a >60% ...