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.

Ariad Pharmaceuticals Inc. got a nice holiday gift from the FDA allowing for immediate resumption of sales of leukemia drug Iclusig (ponatinib), two months after it was suspended from the market, and pushing shares of the troubled biotech up 16.5 percent Friday.

Biocryst Pharmaceuticals Inc. has snatched victory from the jaws of defeat with a new drug application (NDA) filing for intravenous perimavir, a drug that failed a Phase III influenza trial just over a year ago.

Researchers have identified how quiescent T cells die during HIV infection and how to prevent their death using drugs that have already undergone early stage clinical testing. The findings showed that immune system responses contribute to disease progression in HIV-infected individuals.

GW Pharmaceuticals plc, of London, said it filed a registration statement with the SEC for a proposed public offering of American depositary shares, though the number of shares and share price have not yet been determined.

Novogen Ltd., of Sydney, signed a sponsored research agreement with Cornell University. The Weill Cornell Medical College in New York will become the cornerstone of a collaboration across Europe, the U.S., Asia and Australia, involving universities and biotechnology companies seeking a treatment capable of delivering long-term remission for the main form of primary brain cancer, glioblastoma multiforme (GBM).