An ambitious new grant for up to $20 million from the California Institute of Regenerative Medicine (CIRM) will support StemCells Inc.'s preclinical development of its HuCNS-SC neural stem cell product in Alzheimer's disease over a four-year period. The goal of the grant will be filing an investigational new drug application within that time frame. Read More
As the cost of conducting clinical trials helps drive drug prices beyond the wallet of many U.S. patients, the Department of Health and Human Services (HHS) is looking for ways to streamline those trials. Read More
Privately held Kalidex Pharmaceuticals Inc. is set to debut on the biotech stage with an oral presentation and two dozen posters on its broad-spectrum, next-generation fluoroquinolone, KPI-10, at the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), which begins Sunday in San Francisco. Read More
• Galenea Corp., of Cambridge, Mass., and collaborator Kevin Spencer, of the VA Boston Healthcare System and Harvard Medical School, were awarded a five-year, $3 million grant from the National Institute of Mental Health to fund the development of new biomarkers based on brain wave oscillations in animal models of psychosis and in human schizophrenia patients. Read More
• Durata Therapeutics Inc., of Morristown, N.J., completed target enrollment of 556 patients in DISCOVER 1 (Dalbavancin for Infections of the Skin COmpared to Vancomycin at an Early Response), one of two ongoing, global, Phase III trials of lead candidate dalbavancin in acute bacterial skin and skin structure infections (abSSSI). Read More
• Abbott, of Abbott Park, Ill., said it signed a deal with Tokyo-based Astellas Pharma Inc. to collaborate on a Phase III trial testing ASP0113 (TransVax), an investigational vaccine licensed from Vical Inc., of San Diego, for preventing cytomegalovirus (CMV) reactivations in transplant patients. Read More
• Eli Lilly and Co., of Indianapolis, said the Phase III POINTBREAK trial did not meet its primary endpoint of improved overall survival for patients with nonsquamous non-small-cell lung cancer who were randomized to receive a combination of Alimta (pemetrexed) with Avastin (bevacizumab, Roche AG) and carboplatin induction followed by Alimta plus Avastin maintenance, compared to the combination of paclitaxel with Avastin and carboplatin followed by Avastin maintenance. Read More
