Archimedes, Inc. and FDA : Collaboration to Evaluate the Clinical Risks and Benefits of Weight Loss Medications

January 20, 2011 - Clinical Trial Simulation Will Model Obesity Interventions — Archimedes Inc., a healthcare modeling company, announced that it has entered into a Research Collaboration Agreement with the U.S. Food and Drug Administration (FDA) to develop a computer model of clinical trials evaluating weight loss medications. The model will be used to obtain a better understanding of the benefits of weight loss against the long-term risks of cardiovascular outcomes in patients treated with weight loss drugs.

The computer model will attempt to reproduce the results of the Sibutramine Cardiovascular Outcome Trial (SCOUT), which showed that patients receiving sibutramine were 16 percent more likely to suffer serious cardiac events than those who received a placebo. The model is expected to provide insight into the relationship between patient outcomes and cardiovascular risk factors such as blood pressure, heart rate and cholesterol. The model will then be used to explore outcomes over a 10-year simulated extension of the SCOUT trial.

"We are excited about the collaborative work we are conducting with the FDA to further understand the effects of weight loss medications in a population of 'virtual' patients... Archimedes' Press Release -

GlaxoSmithKline : non-core OTC products to be divested

Thursday 14 April 2011 - GSK identified the non-core OTC brands that it intends to divest as the company focuses its Consumer Healthcare business around a portfolio of fast-growing priority brands and the emerging markets. GSK’s intention to divest its non-core Consumer assets was announced at the company’s fourth quarter 2010 results on 3rd February 2011.
The products to be divested, which are primarily sold in Europe and the United States, had sales in 2010 of approximately £500 million, 10% of GSK’s total Consumer Healthcare turnover. They include analgesics: Solpadeine, BC and Goody’s; vitamin and supplement product Abtei; feminine hygiene treatment Lactacyd; and alli for weight management.
Individually, the brands to be divested have strong heritage and good prospects, but GSK has lacked sufficient critical mass in some product categories and certain brands have lacked focus due to other global priorities. GSK therefore believes that other companies are better placed to maximise the potential they offer... GSK 's Press Release -