Richard Pazdur News
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Bayer AG and Algeta ASA won U.S. approval for their drug to treat an advanced prostate cancer that doesn’t respond to standard testosterone-lowering therapy.
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Aveo Pharmaceuticals Inc. failed to win the backing of U.S. regulatory advisers for its lead product candidate, a kidney cancer drug, after the panelists questioned whether it was as effective as existing treatments.
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Celgene Corp.’s therapy for a deadly blood cancer that will sicken more than 22,000 people in the U.S. this year won U.S. regulatory approval.
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Bristol-Myers Squibb Co. won U.S. approval for ipilimumab, the first drug proven to extend the lives of patients with advanced melanoma, the most deadly form of skin cancer. The shares rose the most in nine months.
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Novartis AG, Europe’s biggest drugmaker, won approval to expand the use of its top-selling drug, Gleevec, to children newly diagnosed with the most common pediatric cancer.
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Exelixis Inc. won U.S. regulatory approval for cabozantinib to treat thyroid cancer patients, giving the company its first marketed product.
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Medivation Inc., a biotechnology company whose shares have jumped sixfold in the past 12 months, won approval from U.S. regulators for a late-stage prostate cancer treatment.
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Talon Therapeutics Inc.’s blood- cancer treatment, Marqibo, won approval from U.S. regulators, giving the company its first marketed product.
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Seattle Genetics Inc. won U.S. approval to sell the first new drug for Hodgkin lymphoma in more than 30 years.
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Roche Holding AG and Daiichi Sankyo Co. won U.S. clearance to sell a pill for melanoma that is among a new wave of medicines developed to fight the deadliest form of skin cancer.
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