Bio Saga Blog - A Chronicle of Life Sciences & Informatics

Dako today said that the US Food and Drug Administration has approved two assays for use as companion diagnostics for a Genentech drug targeting HER2-positive metastatic breast cancer. FDA simultaneously approved Dako's HercepTest and HER2 IQFISH pharmDx assays and Genentech's drug Kadcyla (ado-trastuzumab emtansine). Kadcyla is for patients with HER2-positive metastatic breast cancer who have been previously treated with Genentech's Herceptin (trastuzumab) and a taxane chemotherapy. Dako, an Agilent company, and Genentech, a Roche company, have been collaborating on the development of companion diagnostics for Genentech's drugs for a few years. In May 2012 the two firms inked a pact to collaborate on the FDA submission of Dako's assays for Kadcyla. A month later the HercepTest and HER2 FISH pharmDx were approved by FDA as companion diagnostics for Genentech's breast cancer drug Perjeta (pertuzumab). In late 2011, FDA gave the thumbs up to Dako's H...

Biotech companies return to profitability Biotechnology companies worldwide turned a profit last year for the first time since at least 1985 due to reduced spending on research and increased revenue. Profit in the industry was $3.7 billion, compared with a loss of $1.8 billion in 2008, according to a report Wednesday on biotechnology in the United States, Europe, Canada and Australia by London-based Ernst & Young Global. The company has compiled its report annually for 24 years. Research and development spending in the U.S. fell 13 percent last year, with about two-thirds of companies cutting those expenses as capital for some grew scarcer, said Glen Giovannetti, leader of Ernst & Young's global biotech unit. Sixty percent of European firms reduced research costs. At the same time, overall sales increased in the industry, driven primarily by a small number of large companies with well-performing existing products, he said. "What we don't know is ...

Genentech believes a far-sighted approach to patent expiration, unique and life saving drugs and an unrivalled scientific culture will protect it from recession and ensure greater growth than Roche envisions. The comments were made by several Genentech executives at its annual investors meeting, at which the biotech sought to justify its financial model and its belief that Roche’s offer is inadequate. Genentech’s analysis of threats it faces in coming years, and their impact upon the business, included two issues that appeared in President Obama’s budget, namely follow-on biologics and Medicaid reform . Obama backing generic biologics. Ian Clark, executive vice president, commercial, explained that the damage caused by follow-on biologics had been mitigated through planning since 2004. The financial hit that Genentech will take is incorporated into its November financial model but Clark feels that the company is well prepared to face its patent expiration period, which spans 201...