Novo Nordisk A/S, of Bagsvaerd, Denmark, said the FDA approved Tretton, coagulation Factor XIII A-subunit (recombinant), for use in the routine prevention of bleeding in adults and children who have rare clotting disorder congenital Factor XIII A-subunit deficiency. Tretton has orphan drug designation in that indication. Read More
Resverlogix Corp., of Calgary, Alberta, completed enrollment in its exploratory Phase II trial of RVX-208 in patients with pre-diabetes. The goal of the trial is to study insulin secretion, insulin sensitivity and other measures of diabetes and cardiovascular disease. About 20 patients have been enrolled, and data are expected in mid-2014. Read More
Taigen Biotechnology Co. Ltd., of Taipei, Taiwan, said the FDA granted Taigexyn (nemonoxacin) qualified infectious disease product and fast track designations for community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. Read More
Scientists from Stanford University have shown that the genes that lead to a lower response to the influenza vaccine in males are regulated by testosterone, and that a higher testosterone level correlated with lower antibody production to influenza vaccination. Read More
With its lead product, a deuterium-tweaked version of tetrabenazine for hyperkinetic movement disorders, in Phase III testing in chorea associated with Huntington’s disease (HD), orphan drug company Auspex Pharmaceuticals Inc. added its name to the initial public offering (IPO) roster. Read More
The SEC is asking companies and investors to put on their thinking caps for some brainstorming next year on ways to simplify securities disclosure requirements to improve their effectiveness and minimize duplication. Read More
LONDON – Long-awaited new rules on clinical trials in Europe will fail to deliver on the major objective of speeding up approvals, after a political compromise led the proposed timelines for authorizing trials to be extended. Read More
Can-Fite Biopharma Ltd. wowed investors with top-line results from its Phase IIb study of CF101 as a monotherapy for rheumatoid arthritis (RA). In the 12-week, placebo-controlled study of 79 patients with active RA, CF101 met the primary efficacy endpoints, showing statistically significant superiority over placebo in reducing signs and symptoms of RA. Read More
Tesaro Inc.’s stock took a hit Monday when it released results of two Phase III studies showing that while its chemotherapy-induced nausea (CINV) drug rolapitant was effective for treating the condition in the 24-hour to 120-hour period after chemotherapy, it did not improve symptoms in the first 24 hours, and also did not demonstrate sustained improvement after 120 hours. Read More
