Active pharmaceutical ingredients (APIs) produced at Divi Laboratories Ltd., of Chippada Village, India, were put on import alert nearly four months after officials at the facility refused to provide FDA investigators with the original, unmodified audit trail data from Divi's chromatographic systems used to test APIs for the U.S. market. Read More
Uniqure NV, of Amsterdam, said AMT-060, its gene therapy for patients with severe hemophilia B, has received PRIME designation by the EMA, based on results from the ongoing, dose-ranging phase I/II study that show a near cessation of spontaneous bleeding in patients with severe disease at up to 12 months follow-up, along with clinically significant and sustained increases in factor IX (FIX) and substantial reductions in FIX replacement usage. Read More
Asterias Biotherapeutics Inc., of Fremont, Calif., said the data monitoring committee recommended continuation of enrollment in the SciStar phase I/IIa trial testing AST-OPC1 for acute spinal cord injury (SCI), with the 10 million and 20 million cell dose cohorts to continue as planned, following an interim review. Read More
Circle Pharma Inc., of South San Francisco, completed an expansion of its series A financing, with new investors WI Harper Group, Elements Partners LLC, Whitesun Healthcare Ventures Ltd. and Lifeforce Capital joining the round. Read More
AMSTERDAM – Hepatitis B treatment guidelines, newly updated by the European Association for the Study of the Liver to help doctors navigate what EASL governing board member Frank Tacke told BioWorld Today is "lots of dynamic change" during the last couple years, have become the first to recommend the use of the most recently approved HBV drug, Vemlidy. Read More
DUBLIN – Annexin Pharmaceuticals AB completed a listing on the First North exchange in Stockholm last week and is on track to begin clinical trials of its first-in-class therapy for inflammatory vascular disease by year-end. Read More
Should a state court be able to determine the legal precedent for the entire nation when it comes to injury claims against drug or device companies? Read More
BOSTON – "STRIVE establishes calcitonin gene receptor peptide (CGRP) receptor blockade as the first ever mechanism-specific, migraine targeted preventive treatment approach," Peter Goadsby told his audience at the 2017 annual meeting of the American Academy of Neurology. Read More
SHANGHAI – Epimab Biotherapeutics Inc., of Shanghai, now has $25 million in its coffers to put its lead candidate into clinical development, a bispecific antibody for oncology. Read More
Patients with Duchenne muscular dystrophy (DMD) and advanced heart disease enrolled in an exploratory study of Capricor Therapeutics Inc.'s candidate, CAP-1002, saw, at the study's six-month midpoint, improved measures of cardiac structure and upper limb function. The interim data suggest that the therapy, composed of allogeneic cardiosphere-derived cells, could help stave off decompensated heart failure, a common cause of death for individuals with DMD. Read More
Cowen and Co. analyst Eric Schmidt summed up the sentiment of analysts on Biogen Inc.'s first-quarter financials, headlining a note on the company's "solid" performance with the observation that the spinal muscular atrophy (SMA) drug Spinraza (nusinersen) was "sprinting out of the gates." Read More
