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Vertex Pharmaceuticals Incorporated (NASDAQ:VRTX) has reached a non-exclusive agreement with GlaxoSmithKline (NYSE:GSK) though which to conduct a Phase 2 study of an all-oral regimen for the treatment of hepatitis C which contains the former’s nucleotide analogue hepatitis C virus polymerase inhibitor VX-135, along with the later’s NS5A inhibitor GSK2336805. The evaluation should commence early next year, pending discussions with regulatory authorities.
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A mistaken report caused shares of Questcor Pharmaceuticals (NASDAQ:QCOR) to take a dive on Friday, saying that Cerium Pharmaceuticals had been granted an FDA orphan drug designation for Synacthen Depot, which is a synthetic equivalent of Acthar. The headline in error stated that the FDA had okayed a synthetic version of Acthar, rather than the Orphan Drug Designation it had actually been given, says a Seeking Alpha contributor. The headline has since been pulled and refiled to reflect the correction, but the damage to the shares stuck.
The FDA is undertaking an assessment of Johnson & Johnson (NYSE:JNJ) and Boehringer Ingelheim’s Pradaxa using insurance claims and administrative data derived from its safety surveillance program, but found no evidence that the medication increased risk of bleeding when compared with warfarin. The agency initiated an investigation of Pradaxa, which is okayed to decrease the risk of stroke and embolism in patients suffering from atrial fibrillation in 2011, after receiving reports of serious bleeding events in patients using it.
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