The FDA's Gastrointestinal Drugs Advisory Committee (GIDAC) voted unanimously Tuesday that the benefits of NPS Pharmaceuticals Inc.'s Gattex (teduglutide) for short bowel syndrome (SBS) outweighed its risks, and that the drug should be approved. Read More
Shares in Wilex AG plunged 60 percent just before the markets closed in Frankfurt, Germany, Tuesday, on news that a protracted Phase III trial of Rencarex (girentuximab) failed to meet the primary endpoint of disease-free survival in patients with clear cell renal carcinoma (ccRCC). Read More
NEW ORLEANS – Lemming myths aside, suicide is one behavior that cannot be modeled in animal studies. But some of the risk factors that increase suicide risk in humans can. Read More
Unexpected news for investors cropped up in briefing documents posted online by the FDA about Isis Pharmaceuticals Inc.'s lead cholesterol-lowering, antisense candidate Kynamro (mipomersen), and shares of the company took a daylong dive Tuesday as hopes for a positive vote weakened. Read More
• VistaGen Therapeutics Inc., of South San Francisco, completed the previously disclosed $3.25 million financing commitment with Platinum Long Term Growth VII LLC and about $3 million strategic debt restructuring. Read More
• BioLineRx Ltd., of Jerusalem, said it successfully completed the preclinical development of BL-8020, an orally available, interferon-free treatment for the hepatitis C virus and plans to start a Phase I/II safety and efficacy study for the compound in Europe during the first quarter of 2013. Read More
• Resverlogix Corp., of Calgary, Alberta, said it started a Phase II trial in patients with pre-diabetes mellitus to examine the effects RVX-208 and ApoA-I production on glucose metabolism. The trial is being conducted in collaboration with Baker IDI Heart & Diabetes Institute in Melbourne, Australia, and will examine insulin secretion, insulin sensitivity and other parameters. Twenty patients will be enrolled, with data expected in the first half of 2014. RVX-208 is a small molecule designed to inhibit BET bromodomains. Read More
• Novo Nordisk A/S, of Bagsvaerd, Denmark, said it submitted a marketing application in Europe and the U.S. for turoctocog alfa, a third-generation recombinant coagulation Factor VIII intended for prevention and treatment of bleeding with people with hemophilia A. Read More
• Chiesi Group, of Parma, Italy, said it completed a Phase I trial of inhaled PDE4 inhibitor CHF 6001 that showed the drug was well tolerated up to the highest doses administered, in single and multiple dose parts of the study. Read More
