• H. Lundbeck A/S, of Valby, Denmark, said the FDA approved Sabril (vigabatrin) as add-on therapy for the treatment of refractory complex partial seizures in children 10 years and older who have inadequately responded to several other treatments and if the possible benefit outweighs the risks of vision loss.

• Boehringer Ingelheim GmbH, of Ingelheim, Germany, presented data at the American College of Chest Physicians meeting in Chicago from Phase II and Phase III studies testing tiotropium in asthma.

• The FDA plans to submit a formal recommendation to the Department of Health and Human Services (HHS) by early December to reclassify hydrocodone-containing drugs as Schedule II controlled substances.

• Clovis Oncology Inc., of Boulder, Colo., reported interim findings from the Phase I dose-escalation portion of its ongoing Phase I/II study of CO-1686, an oral, targeted covalent inhibitor of mutant forms of the epidermal growth factor receptor (EGFR), for the treatment of non-small-cell lung cancer (NSCLC) in patients with initial activating EGFR mutations and the dominant resistance mutation T790M.

• Celgene International Sarl, of Boudry, Switzerland, a subsidiary of Celgene Corp., presented Phase II results showing that significantly more patients with Behcet’s disease treated with apremilast, its oral, targeted phosphodiesterase 4 inhibitor, achieved complete responses (were free from active oral ulcers) at week 12 vs. those on placebo (71 percent vs. 29 percent, p < 0.0001).

Bleeding and clotting are considered two sides of the same coin, and basically, of course, they are. But by selectively blocking specific aspects of integrin signaling, researchers have reported a way to block clotting without increasing the risk of bleeding.

• Asterias Biotherapeutics Inc., of Menlo Park, Calif., a subsidiary of Biotime Inc., said it plans to file a registration statement next month for a public offering of units, each unit consisting of one share of Series B common stock, $0.0001 per value per share and one redemption right in respect of one share of Series B common stock.

• Portage Biotech Inc., of Toronto, said that as of Oct. 28, its shares will be listed for trading on the Canadian National Stock Exchange, in U.S. currency, under the symbol PBT.U.

The humanized anti-interleukin (IL)-6 monoclonal antibody (MAb) clazakizumab passed muster in its first major study, a dose-ranging Phase IIb in 418 adults with moderate-to-severe rheumatoid arthritis (RA) who had an inadequate response to methotrexate (MTX).