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Human Genome Sciences Inc. (NASDAQ:HGSI), Rockville, Md. GlaxoSmithKline plc (LSE:GSK; NYSE:GSK), London, U.K. Product: Benlysta belimumab (formerly LymphoStat-B) Business: Autoimmune The Scottish Medicines Consortium …
Published on 4/23/2012
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Pharmaxis Ltd. (ASX:PXS; Pink:PXSLY), Frenchs Forest, Australia Product: Bronchitol mannitol Business: Pulmonary The European Commission approved an MAA from Pharmaxis for Bronchitol mannitol for use in cystic fibrosis…
Published on 4/23/2012
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Cytokinetics Inc. (NASDAQ:CYTK), South San Francisco, Calif. Product: CK-2017357 Business: Neurology FDA granted Fast Track designation for Cytokinetics' CK-2017357 to treat amyotrophic lateral sclerosis (ALS). The fast…
Published on 4/23/2012
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Otsuka Pharmaceutical Co. Ltd., Tokyo, Japan Product: Delamanid (OPC-67683) Business: Infectious EMA disclosed that an MAA from Otsuka for delamanid is under review to treat tuberculosis (TB) infection. Delamanid is a …
Published on 4/23/2012
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Gilead Sciences Inc. (NASDAQ:GILD), Foster City, Calif. Johnson & Johnson (NYSE:JNJ), New Brunswick, N.J. Product: Edurant rilpivirine (TMC278); Eviplera (Complera - U.S.) emtricitabine/tenofovir/rilpivirine Business: …
Published on 4/23/2012
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Regeneron Pharmaceuticals Inc. (NASDAQ:REGN), Tarrytown, N.Y. Bayer AG (Xetra:BAYN), Leverkusen, Germany Product: Eylea aflibercept ophthalmic solution (VEGF Trap-Eye) Business: Ophthalmic Regeneron said Centers for …
Published on 4/23/2012
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SkyePharma plc (LSE:SKP), London, U.K. Kyorin Pharmaceutical Co. Ltd. (Tokyo:4569), Tokyo, Japan Mundipharma International Ltd., Cambridge, U.K. Sanofi (Euronext:SAN; NYSE:SNY), Paris, France Product: Flutiform …
Published on 4/23/2012
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Mitsubishi Tanabe Pharma Corp. (Tokyo:4508; Osaka:4508), Osaka, Japan Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland Product: Gilenya fingolimod (FTY720) Business: Autoimmune EMA and FDA updated the label for …
Published on 4/23/2012
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Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland Product: Glivec (Gleevec - U.S.) imatinib (QTI571) Business: Cancer The Scottish Medicines Consortium recommended the restricted use of Novartis' Glivec imatinib on …
Published on 4/23/2012
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Eisai Co. Ltd. (Tokyo:4523; Osaka:4523), Tokyo, Japan Product: Halaven eribulin mesylate (E7389) Business: Cancer Germany's Federal Joint Committee (G-BA) said in a final benefit assessment that breast cancer drug …
Published on 4/23/2012
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Genethon, Evry, France Product: Hematopoietic stem cell gene therapy Business: Inflammation European Commission granted Orphan Drug designation for the not-for-profit's autologous hematopoietic stem cell gene therapy to…
Published on 4/23/2012
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Eisai Co. Ltd. (Tokyo:4523; Osaka:4523), Tokyo, Japan Abbott Laboratories (NYSE:ABT), Abbott Park, Ill. Product: Humira adalimumab Business: Autoimmune The European Commission approved Humira adalimumab to treat …
Published on 4/23/2012
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Halozyme Therapeutics Inc. (NASDAQ:HALO), San Diego, Calif. Baxter International Inc. (NYSE:BAX), Deerfield, Ill. Product: HyQvia, HyQ Business: Hematology Halozyme and partner Baxter said FDA needs additional …
Published on 4/23/2012
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Incyte Corp. (NASDAQ:INCY), Wilmington, Del. Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland Product: Jakavi (Jakafi) ruxolitinib (INCB18424) Business: Hematology EMA's CHMP issued a positive opinion recommending …
Published on 4/23/2012
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Microphage Inc., Longmont, Colo. Product: KeyPath MRSA/MSSA Blood Culture Test-BT Business: Diagnostic FDA granted 510(k) clearance to include the use of 4 BD Bactec blood culture bottles for Microphage's KeyPath MRSA/…
Published on 4/23/2012
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Inspiration Biopharmaceuticals Inc., Cambridge, Mass. Product: Nonacog gamma (IB1001) Business: Hematology Inspiration submitted a BLA to FDA for IB1001 to treat and prevent bleeding in patients with hemophilia B. The …
Published on 4/23/2012
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ThromboGenics N.V. (Euronext:THR), Leuven, Belgium Product: Ocriplasmin (formerly Microplasmin) Business: Ophthalmic As expected, ThromboGenics resubmitted a BLA for ocriplasmin to treat symptomatic vitreomacular …
Published on 4/23/2012
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PinCell s.r.l., Modena, Italy Product: PC111 Business: Autoimmune The European Commission granted Orphan Drug designation for PinCell's PC111 to treat pemphigus. The human mAb against Fas ligand (TNF superfamily, member…
Published on 4/23/2012
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Nuvo Research Inc. (TSX:NRI), Mississauga, Ontario Product: Pliaglis Business: Neurology Nuvo said partner Galderma S.A. (Lausanne, Switzerland) received a complete response letter from FDA for an sNDA for Pliaglis …
Published on 4/23/2012
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Chugai Pharmaceutical Co. Ltd. (Tokyo:4519), Tokyo, Japan Roche (SIX:ROG; OTCQX:RHHBY), Basel, Switzerland Product: RoActemra tocilizumab (RG1569) Business: Autoimmune The Scottish Medicines Consortium recommended …
Published on 4/23/2012
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Depomed Inc. (NASDAQ:DEPO), Menlo Park, Calif. Product: Serada gabapentin GR Business: Endocrine/Metabolic Depomed said it plans to submit an NDA to FDA next half for Serada extended-release gabapentin tablets to treat …
Published on 4/23/2012
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Dainippon Sumitomo Pharma Co. Ltd. (Tokyo:4506; Osaka:4506), Osaka, Japan Novo Nordisk A/S (CSE:NVO; NYSE:NVO), Bagsvaerd, Denmark Product: Surepost (NovoNorm - EU, Prandin - U.S.) repaglinide (SMP-508) Business: …
Published on 4/23/2012
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Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland Product: Tekturna (Rasilez - EU) aliskiren (SPP100) Business: Cardiovascular Novartis updated the label of hypertension drug Tekturna aliskiren in the U.S. to include…
Published on 4/23/2012
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Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland Product: Votubia everolimus (Afinitor, Certican, Zortress) (RAD001) Business: Cancer The Scottish Medicines Consortium recommended against the use of Novartis' …
Published on 4/23/2012
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Merz GmbH & Co. KGaA, Frankfurt, Germany Product: Xeomin Cosmetic (Bocouture - EU) incobotulinumtoxinA (NT 201) Business: Dermatology Merz said Health Canada approved Xeomin Cosmetic incobotulinumtoxinA as a temporary …
Published on 4/23/2012