Eisai's Dacogen Final Results On Overall Survival Get Preliminary Test At Advisory CommitteePreliminary evidence from the pivotal trial of decitabine for acute myelogenous leukemia showed the increase in overall survival wasn't statistically significant, but final results show a benefit of more than 50% compared with the control arm.
Amgen's Xgeva For Castration-Resistant Prostate Cancer Faces Panel Review Without Overall Survival Advantage Delaying or preventing bone metastasis is an important clinical benefit for patients, an FDA official said recently. The Oncologic Drugs Advisory Committee will share its opinion about the product on Feb. 8.
Clinuvel Has Done Its Reimbursement Homework For Orphan Drug Scenesse, But Can It Make Money? As Australia-listed Clinuvel prepares to file its porphyria drug in Europe, it's confident the orphan treatment will win reimbursement. But the firm will have to exploit larger indications like vitiligo in order to provide a return for investors.
Cardiology Groups Look To Enhance Evidence Base On Women Strategies to enhance data that can inform cardiovascular treatments for women are the focus of an effort by the American College of Cardiology and the Society for Cardiovascular Angiography and Interventions.
Former "String Of Pearls" Strategist Tabbed To Lead Teva's Continuing Diversification Jeremy Levin, who left Bristol-Myers Squibb on Jan. 1, will succeed outgoing Teva CEO Shlomo Yanai in May, as the Israeli generics giant seeks to increase its emphasis on branded drugs.
Aveo/Astellas' Tivozanib Bests Nexavar, Barely, In Advanced Kidney Cancer Aveo/Astellas' triple VEGF inhibitor tivozanib hit its progression-free survival endpoint of superiority over Onyx/Bayer's Nexavar (sorafenib), but the question remains whether a three-month PFS advantage can confer first-line market superiority.
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