After an afternoon of vigorous debate, members of the Oncologic Drugs Advisory Committee (ODAC) endorsed, by a 15-1 margin, the benefit/risk profile for peginesatide injection to treat anemia associated with chronic kidney disease (CKD) in adult patients on dialysis. Read More
The future of personalized medicine rests in the hands of the U.S. Supreme Court as it mulls arguments presented Wednesday in Mayo Collaborative Services v. Prometheus Laboratories Inc. Read More
EMBL Ventures GmbH took in €40 million (US$53.5 million) in a first closing of its second fund, bringing an additional tranche of early stage investment to Germany's cash-starved biotechnology sector. And it hopes to add at least another €10 million in a second closing. Read More
Many acute myeloid leukemia (AML) patients who achieve remission after a round of chemotherapy currently have only one medical recourse available: Wait for the cancer to come back. Read More
Lpath Inc., of San Diego, filed to raise up to $10 million through a public offering of stock and warrants. Terms have not yet been set. Lpath trades on the OTCQB. Proceeds would be used for general corporate purposes, including a Phase II trial of iSONEP for wet age-related macular degeneration and a Phase Ib trial of the drug for retinal pigment epithelium detachment. ISONEP is an antibody targeting the bioactive lipid sphingosine-1-phosphate. Read More
Cubist Pharmaceuticals Inc., of Lexington, Mass., said 36.1 million shares of Exton, Pa.-based Adolor Corp. were initially tendered under Cubist's $415 million offer to acquire the biotech. That figure represents about 75 percent of Adolor's shares, and Cubist commenced a subsequent offering period that is scheduled to expire Dec. 9. Read More
Galena Biopharma Inc., of Lake Oswego, Ore., reported five-year efficacy data from an ongoing Phase II trial of NeuVax showing that the vaccine is safe and well tolerated, and demonstrated efficacy in preventing breast cancer recurrence in optimally dosed and boosted patients. Read More