NeoStem Inc. – which has its hands in a variety of cell therapy businesses including early stage research, storage, manufacturing and overseas treatment – is acquiring privately held stem cell firm Amorcyte Inc. Read More
Medicare, and the cost of health care in general, has become the epicenter in the debate over the federal deficit as the administration and Congress look for ways to control the budget. Read More
Cubist Pharmaceuticals Inc., of Lexington, Mass., reported second quarter net U.S. sales of $168.6 million for antibiotic Cubicin (daptomycin), while the firm's net product revenues from international sales were $7.7 million. The company reported total net revenue of $176.8 million, up 9 percent over the same quarter in 2010. Net loss was $20.6 million, or 34 cents per share, far below consensus estimates, which had predicted net income earnings per share of 41 cents. Read More
Transcept Pharmaceuticals Inc., of Point Richmond, Calif., said it received the official complete response letter (CRL) from the FDA, two days after a phone call with the agency indicating there were still outstanding safety issues related to insomnia candidate Intermezzo (zolpidem tartrate sublingual tablet), specifically the drug's next-day residual effects. Transcept, which is seeking to market Intermezzo specifically for middle-of-the-night awakenings, previously conducted a next-day driving study to address the agency's concerns, but said the latest CRL raised concerns relating to differing blood levels of zolpidem among patients and how those might translate into next-day impairment. Read More
Inovio Pharmaceuticals Inc., of Blue Bell, Pa., is recruiting for a Phase II trial evaluating VGX-3100, its investigational SynCon DNA vaccine, in 148 subjects with high grade cervical intraepithelial neoplasia 2/3 or 3. Read More
Late last year, SARcode Bioscience Inc.'s new CEO indicated in a BioWorld interview plans for a Series B round early in 2011 to take its dry eye drug candidate into pivotal testing. (See BioWorld Today, Dec. 29, 2010.) Read More
San Diego-based Vical Inc. signed a potential $130 million-plus license agreement with Astellas Pharma Inc., of Tokyo, for worldwide development and commercialization of Vical's TransVax vaccine for cytomegalovirus (CMV) reactivation in hematopoietic stem cell transplant and solid organ transplant recipients. Read More
