Roche readies late-stage trials for new breast cancer drug; Endo gel fails AIDS trial; Cytori touts breast reconstruction tech

> Roche is expected to announce later today that it will launch new Phase III trials of ImmunoGen's experimental breast cancer drug T-DM1 as it studies whether the therapy can be an effective successor to its blockbuster Herceptin. The therapy matches a new chemotherapy from ImmunoGen with Herceptin. Story

> In a fresh setback, Endo Pharmaceuticals' microbicidal gel failed to prevent AIDS in an African trial that recruited 9,000 women in four African countries. The trial "showed conclusively that Pro 2000 gel was of no added benefit," said the Medical Research Council in the U.K. Endo's shares were hammered earlier this month after the FDA declined to approve its therapy for low testosterone.  Report

> Cytori Therapeutics used the 32nd Annual San Antonio Breast Cancer Symposium to tout preliminary data from a new study of its breast reconstruction technology. Cytori Release

> Canada's Oncolytics is reporting promising results from a new mid-stage study of its cancer therapy Reolysin. "Approximately two-thirds of all cancers involve cells that are Ras-activated," says CEO Brad Thompson. "Reolysin appears to kill off these cancer cells by rupturing their walls, creating a chain reaction of 'explosions' that rip through tumors." Report

> Buoyed by fresh rumors of a potential partnership pact in the wake of positive mid-stage data for voreloxin, shares of Sunesis Pharmaceuticals have been shooting up. Story

> Sanofi-Aventis announced that its breast cancer drug BSI-201 has been fast-tracked by the FDA. Release

> Sanofi Pasteur is planning layoffs at its vaccine facility in Swiftwater, PA. "A number of positions will not be needed in the future, and the employees who hold these positions will be given support to find alternative positions either within Sanofi Pasteur or outside," the company said in a statement. Report

> Evotec AG has received a milestone payment from Ono Pharmaceutical from its research collaboration aimed at identifying novel inhibitors for a protease target. Evotec release

Pharma News

> Riddle me this: Why would children covered by Medicaid get antipsychotic drugs four times more often than children covered by private insurance? And why would the Medicaid kids often get those drugs for less severe conditions than their middle-class counterparts did? The New York Times poses these questions today after federally funded research discovered the imbalance. Report

> GlaxoSmithKline has paid out almost $1 billion to settle lawsuits related to its antidepressant Paxil, Bloomberg reports, citing court records and sources familiar with the litigation. That total includes about $390 million for suicides or suicide attempts allegedly linked to the drug. Some $200 million has gone to settle cases related to Paxil addiction and birth defects and another $400 million to settle antitrust, fraud and design claims. Story

> Bristol-Myers Squibb is on the lookout for a new CFO. Jean-Marc Huet (photo), now EVP and chief financial officer, will leave the company at year's end, to be replaced on an interim basis by Charles Bancroft, most recently VP of Finance for Bristol's global biopharma business. Report

> As usual when oncologists get together to talk shop, lots of pharma news hit the streets over the weekend during the annual Breast Cancer Symposium in San Antonio. Report

Biotech IT News

> Almac is partnering with FACIT.org for electronic distribution of patient-reported outcomes and quality of life assessments. The drug development service provider is validating FACIT assessments via phone, web and handheld device. Report

> Without doubt, most of the literature about the protein interactions of interest in drug discovery is dispersed among scientific journals. Integrating that information is one of the goals of OSDD, the open source drug discovery project being conducted by the Council of Scientific and Industrial Research. The project is attempting to create a more efficient means of discovery for tuberculosis drugs. Story

> Fundación MEDINA researchers use a variety of screening technologies and set-up modifications in their work to identify risks in cardiovascular safety and drug-drug interactions. Scientists at the organization, an outgrowth of the Merck Sharp and Dohme (MSD) Basic Research Center in Madrid, typically use tools, including anti-infective or biochemical inhibition assays and dose-response assay panels, for determining compound risks. Report

> Perceptive Informatics sees a definite uptick in the need for interoperability among automated clinical trial management applications. It has begun answering that need by enhancing the interoperability of two products in its mainstay eClinical suite: DataLabs and ClinPhone. Report

> It's been almost four years in the making, but the FDA's draft guidance on patient-reported outcome measures has now officially dropped the "draft" designation. Story

> Facebook's privacy protection upgrade last week could well be a gateway to more and safer online sharing of patient information--perhaps aiding investigators in such clinical trial activities as subject recruitment. Report

And Finally... While stress wasn't properly named until the 1930s, new research from The University of Western Ontario proves stress has plagued humans for hundreds, and perhaps thousands of years. The first study of its kind, published in the Journal of Archaeological Science, detected the stress hormone cortisol in the hair of ancient Peruvians, who lived between 550 and 1532 A.D. Release

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