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Besins Healthcare S.A., Bangkok, Thailand Product: BHR-100 Business: Inflammation Besins' BHR Pharma LLC subsidiary said the European Commission granted Orphan Drug designation for BHR-100 to treat moderate and severe …
Published on 2/25/2013
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UCB Group (Euronext:UCB), Brussels, Belgium Astellas Pharma Inc. (Tokyo:4503), Tokyo, Japan Product: Cimzia certolizumab pegol Business: Autoimmune UCB submitted regulatory applications to FDA and EMA to extend the …
Published on 2/25/2013
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Exact Sciences Corp. (NASDAQ:EXAS), Madison, Wis. Product: Cologuard stool DNA colorectal cancer screening assay Business: Diagnostic Exact Sciences submitted to FDA the second module of a PMA for its Cologuard stool-…
Published on 2/25/2013
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Gentium S.p.A. (NASDAQ:GENT), Como, Italy Sigma-Tau Group, Pomezia, Italy Product: Defibrotide Business: Hepatic Gentium said that it expects EMA's CHMP to recommend against approval of an MAA for defibrotide to treat …
Published on 2/25/2013
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Epigenomics AG (Xetra:ECX), Berlin, Germany Quest Diagnostics Inc. (NYSE:DGX), Madison, N.J. Sysmex Corp. (Tokyo:6869; Osaka:6869), Kobe, Japan Warnex Inc. (NEX:WNX), Laval, Quebec Abbott Laboratories (NYSE:ABT), Abbott…
Published on 2/25/2013
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Galderma S.A., Lausanne, Switzerland Product: Epiduo adapalene/benzoyl peroxide Business: Dermatology Galderma said FDA approved an sNDA for Epiduo adapalene/benzoyl peroxide gel to treat acne vulgaris in patients 9 …
Published on 2/25/2013
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Agilent Technologies Inc. (NYSE:A), Santa Clara, Calif. Product: HER2 IQFISH pharmDx test Business: Diagnostic Agilent's Dako A/S company said FDA approved the HER2 IQFISH pharmDx test as an aid in the assessment of …
Published on 2/25/2013
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Merck & Co. Inc. (NYSE:MRK), Whitehouse Station, N.J. Sanofi (Euronext:SAN; NYSE:SNY), Paris, France Product: Hexyon/Hexacima (Hexaxim, V419) (DTP-HepB-Polio-Hib Pediatric hexavalent vaccine) Business: Infectious EMA's …
Published on 2/25/2013
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Agendia B.V., Amsterdam, the Netherlands Genomic Health Inc. (NASDAQ:GHDX), Redwood City, Calif. General Electric Co. (NYSE:GE), Fairfield, Conn. Queen Mary University London, London, U.K. Royal Marsden Hospital, London…
Published on 2/25/2013
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Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland Product: Imatinib (Gleevec, Glivec) (QTI571) Business: Cancer EMA's CHMP issued a positive opinion recommending approval of a generic version of imatinib from Actavis…
Published on 2/25/2013
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Genentech Inc., South San Francisco, Calif. ImmunoGen Inc. (NASDAQ:IMGN), Waltham, Mass. Chugai Pharmaceutical Co. Ltd. (Tokyo:4519), Tokyo, Japan Roche (SIX:ROG; OTCQX:RHHBY), Basel, Switzerland Product: Kadcyla ado-…
Published on 2/25/2013
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Lentigen Corp., Gaithersburg, Md. Product: LG631-CD34 (formerly LG631) Business: Hematology Lentigen said FDA granted Orphan Drug designation for LG631-CD34 for bone marrow protection in the treatment of glioblastoma …
Published on 2/25/2013
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Zealand Pharma A/S (CSE:ZEAL), Glostrup, Denmark Sanofi (Euronext:SAN; NYSE:SNY), Paris, France Product: Lyxumia lixisenatide (ZP10, AVE0010) Business: Endocrine/Metabolic FDA accepted for review an NDA from Sanofi for …
Published on 2/25/2013
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Daiichi Sankyo Co. Ltd. (Tokyo:4568; Osaka:4568), Tokyo, Japan Forest Laboratories Inc. (NYSE:FRX), New York, N.Y. H. Lundbeck A/S (CSE:LUN), Copenhagen, Denmark Merz GmbH & Co. KGaA, Frankfurt, Germany Product: Namenda…
Published on 2/25/2013
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Chelsea Therapeutics International Ltd. (NASDAQ:CHTP), Charlotte, N.C. Dainippon Sumitomo Pharma Co. Ltd. (Tokyo:4506; Osaka:4506), Osaka, Japan Product: Northera droxidopa Business: Cardiovascular Chelsea said it will …
Published on 2/25/2013
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Paladin Labs Inc. (TSX:PLB), Montreal, Quebec Stallergenes S.A. (Euronext:GENP), Antony, France Product: Oralair Business: Inflammation FDA accepted for review a BLA from Stallergenes for Oralair to treat grass pollen …
Published on 2/25/2013
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EU Synergy Epitopes S.A., Geneva, Switzerland Orphan Synergy Europe-Pharma S.A., Paris, France Product: OSE 2101 (formerly EP-2101, IDM-2101, EP2101) Business: Cancer Orphan Synergy Europe-Pharma said FDA granted Orphan…
Published on 2/25/2013
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Pluristem Therapeutics Inc. (NASDAQ:PSTI; Tel Aviv:PSTI), Haifa, Israel Product: PLX cells Business: Hematology Pluristem said FDA granted Orphan Drug designation to the company's allogeneic, placental-derived expanded…
Published on 2/25/2013
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Vivus Inc. (NASDAQ:VVUS), Mountain View, Calif. Product: Qsiva (Qsymia - U.S) phentermine/topiramate (VI-0521) (formerly Qnexa) Business: Endocrine/Metabolic EMA's CHMPrejected an MAA for Vivus' obesity drug Qsiva …
Published on 2/25/2013
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Medivir AB (SSE:MVIR B), Huddinge, Sweden Johnson & Johnson (NYSE:JNJ), New Brunswick, N.J. Product: Simeprevir (TMC435) (formerly TMC435350) Business: Infectious Medivir said partner Johnson & Johnson submitted a …
Published on 2/25/2013
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Boehringer Ingelheim GmbH, Ingelheim, Germany Eli Lilly and Co. (NYSE:LLY), Indianapolis, Ind. Product: Tradjenta (Trajenta - EU, Trazenta) linagliptin Business: Endocrine/Metabolic Germany's Federal Joint Committee (G-…
Published on 2/25/2013
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Actelion Ltd. (SIX:ATLN), Allschwil, Switzerland Product: Veletri (Caripul, Epoprostenol "ACT") epoprostenol Business: Cardiovascular Actelion said Japan's Ministry of Health, Labor and Welfare (MHLW) approved a second-…
Published on 2/25/2013
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Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland Product: Zortress everolimus (Afinitor, Certican, Votubia) (RAD001) Business: Transplant FDA approved an sNDA for Zortress everolimus from Novartis to prevent …
Published on 2/25/2013
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Chugai Pharmaceutical Co. Ltd. (Tokyo:4519), Tokyo, Japan Roche (SIX:ROG; OTCQX:RHHBY), Basel, Switzerland Product: Actemra (RoActemra - EU) tocilizumab (RG1569) Business: Autoimmune Roche disclosed in its 4Q12 earnings…
Published on 2/4/2013
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Intelliject Inc., Richmond, Va. Sanofi (Euronext:SAN; NYSE:SNY), Paris, France Product: Allerject epinephrine auto-injector (Auvi-Q) Business: Inflammation Sanofi said Canada approved Allerject epinephrine auto-injector…
Published on 2/4/2013