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Gilead Sciences, Tibotec To Develop Second Once-Daily HIV Treatment
Foster City, Calif.-based Gilead Sciences on Thursday said it has entered into a license and collaboration agreement with Johnson and Johnson subsidiary Tibotec Pharmaceuticals for the development and commercialization of a new once-daily fixed-dose treatment for HIV, the San Francisco Business Times reports. The FDA approved the first once-daily HIV treatment Atripla in 2006 (7/16). The new antiretroviral drug would contain Tibotec"s experimental non-nucleoside reverse transcriptase inhibitor, known as TMC278, and Gilead"s combination pill, Truvada. Kevin Young, head of commercial operations at Gilead "said the new combination pill, along with Gilead"s experimental "quad" pill, will be used for newly-diagnosed patients, with physicians reluctant to change therapy for patients who are responding well to Atripla," Reuters reports. Young said the drug is expected to reach the market in 2011 (Beasley, 7/16).
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Colorectal Cancer Rates Increasing Worldwide, According To Study
A new study finds colorectal cancer incidence rates for both males and females increased in 27 of 51 countries worldwide between 1983 and 2002, and points to increasing Westernization as being a likely culprit. The rise was seen primarily in economically transitioning countries including Eastern European countries, most parts of Asia, and some countries of South America. The study is the first in a peer-reviewed journal to present colorectal cancer incidence trends across all five continents. It appears in the June 2009 issue of Cancer Epidemiology Biomarkers and Prevention. An accompanying editorial says the rise points toward a failed early detection and prevention strategy as well as failure to address lifestyle and dietary challenges of urbanization that affect most of the globe.
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Hot Dogs Should Carry Cancer Warning Labels Says US Non Profit Group
A US non-profit organization filed a lawsuit on Wednesday asking a New Jersey county court to force food companies to put labels warning of
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Menarini International Operations Luxembourg Withdraws Its Marketing Authorisation Application For Factive (gemifloxacin), Europe

The European Medicines Agency has been formally notified by Menarini International Operations Luxembourg S.A. of its decision to withdraw its application for a centralised marketing authorisation for the medicine Factive (gemifloxacin), 320 mg film-coated tablets. Factive was expected to be used for the treatment of bacterial infections causing mild to moderate community-acquired pneumonia and acute exacerbation of chronic bronchitis. The application for the marketing authorisation for Factive was submitted to the Agency on 26 March 2008. At the time of the withdrawal, it was under review by the Agency"s Committee for Medicinal Products for Human Use (CHMP). In its official letter, the company stated that the withdrawal of the application was based on the CHMP"s view that the data provided did not allow the Committee to conclude on a positive benefit-risk balance for Factive at that time. More information about Factive and the state of the scientific assessment at the time of withdrawal will be made available in a question-and-answer document. This document, together with the withdrawal letter from the company, will be published on the Agency"s website after the next CHMP meeting of 22-25 June 2009. Notes 1. Withdrawal of an application does not prejudice the possibility of a company making a new application at a later stage. 2. This press release, together with other information on the work of the Agency, can be found on the Agency"s website: http://www.emea.europa.eu. EMEA


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