IRESSA (Gefitinib) Receives Marketing Authorisation in Europe
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- Category: AstraZeneca
AstraZeneca announced that the European Commission has granted marketing authorisation for the oral anti-cancer drug, IRESSA for the treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of EGFR-TK (epidermal growth factor receptor-tyrosine kinase) across all lines of therapy.
Pfizer Discontinues Phase 3 Trial of Sutent® in Metastatic Colorectal Cancer
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- Category: Pfizer
Pfizer Inc announced the discontinuation of the SUN 1122 Phase 3 trial that evaluated Sutent® (sunitinib malate) plus FOLFIRI (irinotecan plus infusional 5-fluorouracil and leucovorin) versus FOLFIRI alone for the first-line treatment of metastatic colorectal cancer (CRC).
AstraZeneca Development Partner, Pozen, Inc., Submits New Drug Application for PN400
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- Category: AstraZeneca
AstraZeneca announced that its development partner, Pozen, Inc., has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for VIMOVO (PN400) (enteric coated naproxen/esomeprazole magnesium) tablets, a product under investigation for the treatment of the signs and symptoms of osteoarthritis (OA), rheumatoid arthritis (RA) and ankylosing spondylitis (AS) in patients who are at risk of developing NSAID-associated ulcers.
Bayer Schering Pharma Extends Research Portfolio in the Field of Cancer-Related Targets
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- Category: Bayer
Bayer Schering Pharma AG, Germany, has entered into an exclusive license agreement with Celera Corporation, California, USA, providing Bayer Schering Pharma with access to five cancer-related targets for therapeutic development and in-vivo diagnostic imaging. These therapeutic targets were identified by Celera's proteomics discovery platform.
Novo Nordisk reaches settlement with the Danish authorities regarding Oil-for-Food activities
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- Category: Novo Nordisk
Novo Nordisk has reached a settlement with the Danish Public Prosecutor for Serious Economic Crime regarding the company's sales to Iraq during 2000 to 2003 under the United Nations Oil-for-Food programme.
Lundbeck receives FDA Complete Response Letter on Serdolect® for the treatment of schizophrenia
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- Category: Lundbeck
H. Lundbeck A/S (LUN.CO; LUN DC) has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) for Serdolect® (sertindole) for the treatment of schizophrenia.
Sutent Significantly Improved Progression-Free Survival
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- Category: Pfizer
Pfizer has announced results from a randomized Phase 3 trial of Sutent (sunitinib malate) in patients with advanced pancreatic islet cell tumors, also known as pancreatic neuroendocrine tumors, which is a different type of cancer than the more common pancreatic adenocarcinoma. Study findings demonstrated that median progression-free survival (PFS) was 11.1 months in patients treated with Sutent compared to 5.5 months in patients treated with placebo.
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