FDA has yet to approve any ANDAs for generic Lipitor (atorvastatin) or resolved the question of whether Ranbaxy is entitled to 180-day generic marketing exclusivity. In its failed suit against the agency, Mylan pointed to June 28 as the earliest date FDA could tentatively approve ANDAs for the world's top-selling drug. Mylan had sought a court order requiring FDA to announce whether Ranbaxy was eligible for exclusivity.
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Rare disease start-up scores Series A financing and technology patents to develop a treatment for a deadly genetic disorder.
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Continue reading "Latest News From "The Pink Sheet" DAILY - Genentech's Avastin Plan Foiled By FDA Advisors " »
ODAC hears details on Genentech’s proposed confirmatory trial for Avastin in breast cancer.
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Eli Lilly, AstraZeneca, Forest Laboratories and UCB. These are just some of the companies that are paying millions for improperly using off-label marketing.
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Proposed study of bevacizumab in first-line metastatic breast cancer is unlikely to substantiate the magnitude of progression-free survival benefit seen in the E2100 trial, Division of Biologic Oncology Products Director Patricia Keegan says.
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Continue reading "Latest News From "The Pink Sheet" DAILY - CDER/Roche Face Off On Avastin" »
FDA hearing on Avastin breast cancer claim opens with Center for Drug Evaluation and Research officials attacking Genentech’s plans for a new confirmatory study.
Continue reading "Coming In Wednesday's "The Pink Sheet" DAILY - FDA Is Critical Of Genentech Plans For New Avastin Study" »
