The Indian health minister Anbumani Ramadoss urged Novartis earlier this month to end its legal bid to win patent protection for its oncologic Gleevec, or he said the government may override existing patents for vitally necessary drugs by issuing licenses that allow Indian generic manufacturers to produce cheaper versions in the interest of public health.
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ArQule's agreement with Tokyo biotech Kyowa to develop and commercialize Phase I oncology molecule ARQ 197 in Asia will give the firm a much-needed cash infusion to support the product's development in the U.S.
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The FDA requires a new regulatory model to confront issues presented by globalization, which will include reliance on foreign regulators, according to agency Chief Medical Officer Janet Woodcock.
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Novartis is concerned that the changing intricacies of the Indian legal system will indefinitely delay its court case challenging the Indian Patent Office's denial of the Gleevec (imatinib) patent in the developing country.
Continue reading "Lost In Bureaucracy? Novartis Gleevec IP Case Held Up By Indian Legal System" »
Roche/Genentech's Avastin (bevacizumab) has become the first biologic approved to treat colorectal cancer in Japan; Roche's Japanese partner Chugai announced the approval April 18.
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Abbott announced April 10 that it would cut the price of its HIV therapy Kaletra (lopinavir/ritonavir) in more than 40 developing countries to around $1,000 per patient annually.
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