Trials & Filings
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November 30, 2009
The FDA sent a "refuse to file" letter to EMD Serono for the NDA for Cladribine Tablets
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November 23, 2009
Pfizer received approval from the FDA for Geodon (ziprasidone HCI) Capsules for maintenance treatment of bipolar I disorder as an adjunct to lithium or valproate in adults.
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November 19, 2009
PharmaNet Development Group has been selected to conduct and manage Scancell Ltd.’s Phase I/II trial with SCIB1 scheduled for 1H10.
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November 19, 2009
AstraZeneca has submitted a NDA to the FDA for Brilinta, an investigational oral antiplatelet treatment for the reduction of major adverse cardiac events in patients with acute coronary syndrome (ACS).
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November 18, 2009
Genzyme Corp. reported results of a Phase II/III study of its advanced phosphate binder (APB).
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November 17, 2009
Genentech has submitted two sBLAs to the FDA for Avastin for the treatment of women who have not received chemotherapy for advanced (metastatic) HER2-negative breast cancer (first-line treatment).
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November 11, 2009
GlaxoSmithKline received approval from the FDA for its sBLA for unadjuvanted influenza A (H1N1) pandemic vaccine.
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November 10, 2009
Novavax, Inc. initiated a Phase IIa study of its trivalent seasonal influenza VLP vaccine candidate in healthy adults 60 years of age or older.
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November 6, 2009
Gloucester Pharmaceuticals received approval from the FDA for Istodax (romidepsin) for the treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy.
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November 6, 2009
Ziopharm Oncology, Inc. achieved positive data from the multicenter randomized Phase II trial of palifosfamide (ZymafosTM, ZIO-201) in patients with unresectable or metastatic soft tissue sarcoma.
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October 28, 2009
AstraZeneca withdrew its regulatory submissions Zactima (vandetanib) 100mg in combination with chemotherapy in patients with advanced non-small cell lung cancer (NSCLC) from the FDA and the EMEA. The applications were submitted in June 2009.
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October 27, 2009
GSK and Genmab have received approval of Arzerra (ofatumumab) from the FDA for use in patients with chronic lymphocytic leukemia (CLL) that do not respond to fludarabine and alemtuzumab.
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October 26, 2009
Exelixis and Bristol-Myers Squibb achieved positive Phase II data showing that XL184 demonstrated activity in patients with glioblastoma multiforme (GBM), the most common and aggressive form of brain cancer.
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October 19, 2009
Amgen received a Complete Response Letter from the FDA for Prolia's BLA
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October 16, 2009
GlaxoSmithKline gained approval for Cervarix in Japan, becoming the first cervical cancer vaccine to be approved by the Japanese Ministry of Health, Labour and Welfare (MHLW).
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181 - 195 of 604 results
