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.

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.

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.

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.

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.

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.

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.

DUBLIN – Cashing in on the steep climb in its valuation over the last six months, Gentium SpA agreed to a $57-per-share acquisition deal with Jazz Pharmaceuticals plc, which values the company at about $1 billion.

Intrexon Corp.’s $26 million takeover of Medistem Inc. brings aboard endometrial regenerative cells (ERCs), derived from menstrual blood, for use with integrated synthetic biology platforms developed by Intrexon, opening potential for cell-based therapeutic candidates across a range of conditions.