Despite the fact that they collectively affect tens of millions of people in the U.S. alone, the origins of autoimmune diseases are still largely mysterious. Figuring out which proteins manage to enrage the immune system sufficiently to mount an attack, and why, has largely been a matter of testing for antibodies to a few proteins, and diagnosing an autoimmune condition if a patient reacts to them. Read More
A year after the FDA rejected Cell Therapeutics Inc.'s (CTI) pixantrone application for relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL), the Office of New Drugs (OND) has denied an appeal request from CTI, which claimed the drug showed efficacy. Read More
Six months after receiving a surprise complete response letter from the FDA for agitation drug AZ-004 (Staccato loxapine), Alexza Pharmaceuticals Inc. padded its coffers before trying again. Read More
Dendreon Corp., of Seattle, reported $28.1 million in revenue for the first quarter, thanks to sales of prostate cancer vaccine Provenge (sipuleucel-T). The figure was just barely shy of analyst expectations of $28.9 million. Dendreon also reported $15 million in April Provenge sales, which analysts viewed as encouraging. Read More
AtheroNova Inc., of Irvine, Calif., will pursue an additional indication to address unmet needs in stroke prevention with a compound to treat intracranial atherosclerosis disease, regarded as a primary cause of ischemic stroke. AtheroNova is conducting two second-round preclinical studies evaluating the atherosclerotic plaque regression efficacy of the company's compounds. Read More
PolyMedix Inc., of Radnor, Pa., presented data from two Phase Ib/II trials of PMX-60056, a synthetic small molecule designed to reverse the anticoagulation activity of heparin and low molecular weight heparins. The data suggested that both heparin and tinzaparin appear to bind on a one-to-one molecular basis with PMX-60056, which could simplify dosing in future trials. The compound is in a Phase II trial to assess the safety and efficacy of reversing heparin in patients undergoing percutaneous coronary intervention procedures. Read More
SAN FRANCISCO – Burrill & Co. reported last month that the past decade of merger and acquisition (M&A) activity by major pharmaceutical firms has failed to build value, suggesting that the drug development industry might be wasting its time on acquisitions. Read More
One way or the other, Mountain View, Calif.-based Vivus Inc. expects to resubmit a new drug application (NDA) for obesity drug Qnexa (phentermine/topiramate) in the fourth quarter. Read More
