Regeneron Inc.'s Zaltrap (ziv-aflibercept) won FDA approval Friday in metastatic colorectal cancer, for use in combination with FOLFIRI (folinic acid, fluorouracil and irinotecan) chemotherapy, a little more than a year after surprising investors with positive data in a pivotal trial. Read More
WASHINGTON – Optimer Pharmaceuticals Inc.'s Dificid hit the market a few years too soon to take advantage of the exclusivity offered for new antibiotics under the FDA Safety and Innovation Act (FDASIA), but the Clostridium difficile-fighting drug is getting a regulatory hand up from another agency. Read More
Shares in Allergy Therapeutics plc surged 36 percent Friday on news that the FDA had finally lifted a five-year clinical hold on the development of its Monophosphoryl Lipid A (MPL)-adjuvanted grass pollen allergy vaccine (Grass MATA MPL/ Pollinex Quattro Grass 0.5ml) and had cleared a Phase III protocol for determining the product's efficacy. Read More
In its second quarterly earnings report for 2012, Aveo Pharmaceuticals Inc., of Cambridge, Mass., said the FDA is concerned about overall survival trends in its ongoing TIVO-1 trial of tivozanib compared to sorafenib (Nexavar, Onyx Pharmaceuticals Inc.) in 517 patients with advanced renal cell carcinoma. Read More
• Furiex Pharmaceuticals Inc., of Morrisville, N.C., said it restructured its loan and security agreement with MidCap Financial LLC and Silicon Valley Bank to add $30 million to the existing $10 million loan. Read More
• Catalyst Pharmaceutical Partners Inc., of Coral Gables, Fla., reported that it has regained compliance with the $1 minimum bid price requirement for continued listing on the Nasdaq Capital Market. The company's shares trade under the symbol CPRX. Read More
• Healthpoint Biotherapeutics, of Fort Worth, Texas, said that the results for its Phase IIb trial investigating the efficacy of HP802-247 in venous leg ulcers are published in The Lancet. Read More
• GlaxoSmithKline plc (GSK), of London, said it submitted applications in the European Union and the U.S. for use of its BRAF inhibitor dabrafenib as a treatment for adults with unresectable or metastatic melanoma with a BRAF V600 mutation. Read More
• Pfizer Inc., of New York, reported that a Phase IV study assessing the efficacy and safety of Toviaz (fesoterodine fumarate) in patients with overactive bladder met its primary endpoint of reducing urge urinary incontinence (UUI). Read More
