Intercept Finishes POISE Enrollment, Amarin Submits NDA: Healthcare Business Report
Intercept Pharmaceuticals (ICPT) said that it has finished enrollment in POISE, its pivotal Phase 3 clinical trial of obeticholic acid in primary biliary cirrhosis. Results from the 12-month double-blind portion of POISE should be available in the second quarter of 2014 and if successful, will be used to seek regulatory approval of OCA, a first-in-class FXR agonist, as a second line treatment in PBC. Intercept surpassed its targeted number of patients by enrolling 218 patients at 59 centers in 13 countries, thus completing enrollment in POISE more rapidly than originally expected.
Johnson & Johnson’s (NYSE:JNJ) new drug, bedaquiline, is featured in an FDA review that describes how it treats drug-resistant TB, along with Cepheid’s (NASDAQ:CPHD) expectation to have its new, faster TB diagnostic test ready in the United States by mid-2013. Domestically, rates of multidrug-resistant tuberculosis are low but are inching back up, with new threats appearing as drug resistance worsens overseas and more dangerous strains develop and spread, says the Wall Street Journal.
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Amarin Corporation (NASDAQ:AMRN), reported Wednesday the submission of a Supplemental New Drug Application to the FDA, requesting clearance for Chemport as an additional Vascepa (icosapent ethyl) active pharmaceutical ingredient supplier. Amarin is a biopharmaceutical firm that concentrates on the commercialization and development of therapeutics for the improvement of cardiovascular health.
In a hit to Merck KGaA (MKGAF.PK) and the high-risk field of using vaccines to fight tumours, the company’s experimental lung cancer vaccine did not improve survival in a pivotal study. Stimuvax, which Merck licensed from the American biotech firm Oncothyreon, failed to boost overall survival in the Phase III clinical trial, which coordinating investigator, Frances Shepherd at the University of Toronto, commented that the result was disappointing, but said “notable treatment effects were observed in certain subgroups of patients”.
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