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Molecular Insight Pharmaceuticals, Inc. Receives European Medicines Agency Approval To Proceed With Phase 3 Development Of OnaltaTM
Molecular Insight Pharmaceuticals, Inc. (NASDAQ: MIPI) announced that the European Medicines Agency (EMEA) has approved its Phase 3 protocol for Onalta (Yttrium-90 edotreotide). Onalta is the Company"s lead radiotherapeutic product candidate under development for the treatment of metastatic carcinoid and pancreatic neuroendocrine tumors in patients whose symptoms are not controlled by conventional therapy. The compound has shown the potential to selectively deliver lethal radiation to cancer cells. The proposed Phase 3 trial will confirm that administration of Onalta results in stabilization, regression or complete remission of the carcinoid tumor, and improves carcinoid-related symptoms when compared to a high-dose regimen of the current standard therapy for this disease, Sandostatin®. With EMEA"s approval of its proposed Phase 3 protocol in hand, Molecular Insight can proceed with the final clinical trial that will position Onalta for marketing authorization in the EU.
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How Oxidative Stress May Help Prolong Life
Oxidative stress has been linked to aging, cancer and other diseases in
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UN Secretary-General, World AIDS Campaign And UNAIDS Launch World AIDS Day Theme Of 'Universal Access And Human Rights'
Ahead of this year"s World AIDS Day, the United Nations Secretary-General Ban Ki-moon, the World AIDS Campaign and the Joint United Nations Programme on HIV/AIDS (UNAIDS) have come together to announce the theme of "Universal Access and Human Rights".
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Oncologic Drugs Advisory Committee Meeting Set By FDA

Medical Industry E-Mail News Service™ -- July 07 2009 -- The US Food & Drug Administration (FDA) has announced that its Oncologic Drugs Advisory Committee will meet on July 15 2009, in Gaithersburg MD, to discuss (1) new drug application (NDA) 022-447, proposed trade name Yondelis (trabectedin) powder, for concentrate for solution for intravenous infusion, Centocor Ortho Biotech Products, L.P., proposed indication in combination with Doxcil (doxorubicin HCl liposome injection), for treating patients with relapsed ovarian cancer; and (2) supplemental new drug application (sNDA) 050-718/S-039, Doxil (doxorubicin HCl liposome injection), for intravenous infusion, Centocor Ortho Biotech Products, L.P., proposed indication in combination with docetaxel for treating patients with locally advanced or metasatic breast cancer who have received prior anthracycline treatment. There is no charge to attend. When & Where July 15 2009; 8 am-5 pm Hilton Washington DC N/Gaithersburg Ballrooms 620 Perry Pkwy Gaithersburg MD FDA Center for Drug Evaluation & Research (HFD-21)


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