Shares in Clavis Pharma ASA (OSLO:CLAVIS) plummeted by more than 87 percent Monday following the failure of CO-101 (CP-4126) to demonstrate any impact on survival in a pivotal Phase II trial in metastatic pancreatic cancer. Read More
Gilead Sciences Inc. reported stunning interim results from its Phase II ELECTRON study of 12 weeks of therapy with investigational hepatitis C (HCV) combo sofosbuvir (GS-7977) and GS-5885 with ribavirin showing the best-possible results at four weeks after treatment, a 100 percent sustained virologic response (SVR4). Read More
The FDA threw a wrench into the fireworks for AstraZeneca plc and Nektar Therapeutics Inc. after the companies reported positive top-line findings from two Phase III studies and a safety extension trial of naloxegol (NKTR-118) in noncancer-related pain and opioid-induced constipation (OIC). Read More
Top-line data from a Phase III trial with Abraxane plus gemcitabine in pancreatic cancer by Celgene Corp.'s subsidiary Celgene International Sàrl suggested a benefit over the chemotherapy agent alone in overall survival (OS). Read More
• Idera Pharmaceuticals Inc., of Cambridge, Mass., said it raised $7 million in a private placement by issuing 424,242 shares of its convertible preferred stock (convertible into 8,484,840 shares of common stock) and warrants to purchase 8,484,840 shares of common stock. Read More
• Morphotek Inc., of Exton, Pa., a subsidiary of Eisai Inc., said it has been granted FDA orphan drug designation for its investigational cancer drug, amatuximab (MORAb-009), a chimeric IgG1 antibody that targets a cell surface glycoprotein, mesothelin. Read More
• CellAct Pharma GmbH, of Dortmund, Germany, said its topoisomerase inhibitor CAP7. 1 showed promising safety and tolerability in heavily pretreated solid tumors. Read More
• Galectin Therapeutics Inc., of Norcross, Ga., presented preclinical data on the mechanism of action of GR-MD-02, its lead galectin inhibitor in non-alcoholic steatohepatitis (NASH), or fatty liver disease. Galectin-3 protein expression was markedly increased in animals with NASH, and those levels were reduced to barely detectable levels following treatment with GR-MD-02. Read More
• Infinity Pharmaceuticals Inc., of Cambridge, Mass., released new data from its completed Phase I study of IPI-145, the company's oral inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma. Read More
• Watson Pharmaceuticals Inc., of Parsippany, N.J., said subsidiary Watson Laboratories Inc. received FDA approval on its abbreviated new drug application for sildenafil tablets, 20 mg, the generic equivalent to New York-based Pfizer Inc.'s Revatio, for the treatment of pulmonary arterial hypertension in adults to improve exercise ability and delay clinical worsening. Read More
• Merck and Co. Inc., of Whitehouse Station, N.J., presented early interim results from a single-arm, open-label Phase Ib study of MK-3475, its investigational immune-modulating therapy, in advanced melanoma. Based on data for 85 of 132 patients enrolled in the study to date, 43 patients (51 percent) showed an objective antitumor response and eight patients (9 percent) showed a complete response at or after the 12-week assessment. Read More
