India's Drug and Cosmetics Act purports to keep clinical trials kosher under something called Schedule Y, but the law – which has not been amended since 2005 – lacks rules for mandatory practice and does not specify what recourse trial participants have when things go wrong.
Dry-eye syndrome (DES) was not the first indication that OphthaliX Inc. planned to tackle with its first-in-class A3 adenosine receptor agonist CF101, though a 24-week, 236-patient, placebo-controlled Phase III trial is already enrolled, from which data are expected to spill out by the fourth quarter of this year.
India's Drug and Cosmetics Act purports to keep clinical trials kosher under something called Schedule Y, but the law – which has not been amended since 2005 – lacks rules for mandatory practice and does not specify what recourse trial participants have when things go wrong.
The FDA published a notice in the Federal Register about the public workshop called "Drug Development for Chronic Fatigue Syndrome [CFS] and Myalgic Encephalomyelitis [ME]," slated for April 25-26 in Bethesda, Md.
The same month that researchers published confirmatory findings in Nature Biotechnology (NBT) that "rising-star," emerging markets do not represent much of a near-term challenge to U.S. drug developers, the venture capital (VC) firm Domain Associates disclosed a push to help Western countries gain footholds in China.
Bolstering its news in January, when the firm disclosed that the intravenous antiplatelet cangrelor had proven strong in a Phase III trial as compared to oral clopidogrel, The Medicine Co.'s scientific team offered specifics over the weekend at the American College of Cardiology Scientific Session in San Francisco.
The first signs surfaced in about 2007 that maybe China and India would not soon become the drug-development giants that the U.S. industry believed, and new research published as correspondence in the March 2013 issue of Nature Biotechnology seems to confirm suspicions about emerging markets.
Repurposing approved drugs – many of which already are being used for symptom relief – to give them official labels for chronic fatigue syndrome (CFS) will be one topic at an FDA-sponsored workshop next month on drug development for CFS and myalgic encephalomyelitis (ME).
Their oral combo drug's 100 percent success rate in hepatitis C virus (HCV) patients with liver fibrosis did not do much for shares of Medivir AB and partner Gilead Sciences Inc., probably because the positive interim results from the Phase IIa trial were "baked in" by investors, who must wait to find out more.
