Eisai Announces Extension Of FDA Review Of Drug Application For Investigational Agent Eribulin Mesylate
Eisai Announces Extension Of FDA Review Of Drug Application For Investigational Agent Eribulin Mesylate
Eisai Inc. announced today that it has received notification from the U.S. Food and Drug Administration (FDA) that the agency expects to complete priority review of the eribulin mesylate New Drug Application (NDA) for locally advanced or metastatic breast cancer on or before December 30, 2010, which is a three month extension from the original Prescription Drug User Fee Act (PDUFA) action date …
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Categories: Breast Cancer Tumor Tags: Agent', Announces, application, drug, Eisai, Eribulin, Extension, Investigational, Mesylate, Review
Roche provides update on FDA application for T-DM1
Roche provides update on FDA application for T-DM1
Roche expects a global regulatory submission mid 2012. Roche today announced that the U.S. Food and Drug Administration (FDA) issued a Refuse to File letter for accelerated approval for the company’s trastuzumab-DM1 (T-DM1) Biologics License Application (BLA). As planned Roche will…
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Categories: Breast Cancer Tumor Tags: application, Provides, Roche, TDM1, Update
Advaxis’ ‘Prokaryotic peptides for enhancing antigen immunogenicity’ European patent application allowed
Advaxis’ ‘Prokaryotic peptides for enhancing antigen immunogenicity’ European patent application allowed
Advaxis, Inc.,, the live, attenuated Listeria monocytogenes (Lm) immunotherapy company, has been notified by the European Patent Office that patent application WO2001/072329, for the use of Prokaryotic PEST-Like Peptides for Enhancing Immunogenicity of Antigen has been allowed for issuance. This patent will be #1,303,299 when granted, and will be licensed exclusively to Advaxis by the University …
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Categories: Breast Cancer Tumor Tags: 'Prokaryotic, Advaxis, allowed, antigen, application, enhancing, European, immunogenicity', Patent, peptides
FDA Grants Priority Review Designation to Denosumab Biologics License Application for the Reduction of Skeletal …
FDA Grants Priority Review Designation to Denosumab Biologics License Application for the Reduction of Skeletal …
Amgen today announced that the U.S. Food and Drug Administration has granted priority review designation to denosumab, a subcutaneous RANK Ligand inhibitor, for the treatment of bone metastases to reduce skeletal related events in patients with cancer.
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Categories: Breast Cancer Risks Tags: application, Biologics, Denosumab, Designation, Grants, License, priority, reduction, Review, Skeletal
Pfizer Prepares For Voluntary Withdrawal Of U.S. New Drug Application And For Discontinuation Of Commercial …
Pfizer Prepares For Voluntary Withdrawal Of U.S. New Drug Application And For Discontinuation Of Commercial …
Pfizer Inc. (NYSE: PFE) announced today that based on discussions with the U.S. Food and Drug Administration (FDA), it will be discontinuing commercial availability of Mylotarg® (gemtuzumab ozogamicin for Injection) (used for the treatment of relapsed acute myeloid leukemia (AML)) in the United States and that it will be voluntarily withdrawing the new drug application (NDA) for Mylotarg …
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Categories: Breast Cancer Doctors Tags: application, Commercial, Discontinuation, drug, Pfizer, Prepares, U.S., Voluntary, Withdrawal