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.
GSK and Chroma Therapeutics form alliance to develop novel macrophage-targeted drugs
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- Category: GlaxoSmithKline
GlaxoSmithKline (LSE: GSK) and Chroma Therapeutics Limited announced a collaboration to develop macrophage-targeted compounds using Chroma's proprietary esterase-sensitive motif (ESM) technology, which adds amino acid esters to compounds with the aim of targeting the compounds to specific cells in the inflammatory disease process.
New biological therapy Ilaris® approved in US
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- Category: Novartis
The US Food and Drug Administration (FDA) has approved Ilaris® (canakinumab) for the treatment of children and adults with cryopyrin-associated periodic syndrome (CAPS), which includes a number of rare but life-long auto-inflammatory disorders with debilitating symptoms and limited treatment options[1],[2],[3],[4].
Nycomed receives Marketing Authorization for Pantoprazole 20mg OTC from European Commission
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- Category: Nycomed
Nycomed received marketing authorisation from the European Commission for five applications: PANTOZOL Control®, PANTOLOC Control®, PANTECTA Control®, SOMAC Control® and CONTROLOC Control®. This new OTC medication is intended for short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults as a medicinal product not subject to medical prescription.
GSK announces a strategic alliance with Dr. Reddy's Laboratories Ltd
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- Category: GlaxoSmithKline
GlaxoSmithKline plc (GSK) has announced an agreement with Dr. Reddy's Laboratories Ltd (Dr. Reddy's) to develop and market selected products across an extensive number of emerging markets, excluding India.
Abbott Initiates Trial of Next-Generation XIENCE PRIME(TM) Drug Eluting Stent
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- Category: Abbott
Abbott (NYSE: ABT) has announced the initiation of SPIRIT PRIME, a clinical trial to study the performance of the company's next-generation XIENCE PRIME(TM) Everolimus Eluting Coronary Stent System, currently an investigational device, for the
treatment of coronary artery disease. Results from SPIRIT PRIME will be used to support the regulatory filing for XIENCE PRIME in the United States.
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