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Chronological Index of : Regulatory

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  • Akynzeo netupitant/palonosetron regulatory update

    Helsinn Healthcare S.A., Lugano, Switzerland Sinclair IS Pharma plc (LSE:SPH), London, U.K. Product: Akynzeo netupitant/palonosetron (NEPA) (formerly Netu-palo-FDC) Business: Gastrointestinal The European Commission …

    Published on 6/15/2015
  • Alprolix regulatory update

    Biogen Inc. (NASDAQ:BIIB), Cambridge, Mass. Swedish Orphan Biovitrum AB (SSE:SOBI), Stockholm, Sweden Product: Alprolix, Long Acting rFactor lX, rFIXFc Business: Hematology Biogen submitted an MAA to EMA for Alprolix to…

    Published on 6/15/2015
  • Amplidiag H regulatory update

    Mobidiag Ltd., Helsinki, Finland Product: Amplidiag H. pylori+ClariR Business: Infectious Mobidiag received CE Mark approval for Amplidiag H. pylori+ClariR test to detect Helicobacter pylori and resistance to …

    Published on 6/15/2015
  • Anthim obiltoxaximab regulatory update

    Elusys Therapeutics Inc., Pine Brook, N.J. Product: Anthim obiltoxaximab (ETI-204) Business: Infectious FDA accepted a BLA for Anthim obiltoxaximab from Elusys to treat and prevent inhalational anthrax. The PDUFA date …

    Published on 6/15/2015
  • Bosatria mepolizumab regulatory update

    GlaxoSmithKline plc (LSE:GSK; NYSE:GSK), London, U.K. Product: Bosatria mepolizumab (SB-240563) Business: Inflammation FDAs Pulmonary-Allergy Drugs Advisory Committee voted 14-0 that efficacy and safety data support …

    Published on 6/15/2015
  • BromSite regulatory update

    InSite Vision Inc. (OTCBB:INSV), Alameda, Calif. Product: BromSite (ISV-303) Business: Ophthalmic InSite submitted an NDA to FDA for BromSite to treat inflammation and prevent pain in cataract surgery. BromSite is low-…

    Published on 6/15/2015
  • Cobas HSV 1 and 2 test regulatory update

    Roche (SIX:ROG; OTCQX:RHHBY), Basel, Switzerland Product: Cobas HSV 1 and 2 test Business: Infectious FDA granted 510(k) clearance to Roches cobas HSV 1 and 2 test to detect and differentiate herpes simplex virus type 1…

    Published on 6/15/2015
  • Daratumumab regulatory update

    Genmab A/S (CSE:GEN; OTCBB:GMXAY), Copenhagen, Denmark Johnson & Johnson (NYSE:JNJ), New Brunswick, N.J. Product: Daratumumab (HuMax-CD38) Business: Cancer Johnson & Johnsons Janssen Research & Development LLC unit …

    Published on 6/15/2015
  • DPP HIV 1/2 Assay regulatory update

    Chembio Diagnostics Inc. (NASDAQ:CEMI), Medford, N.Y. Product: DPP HIV 1/2 Assay Business: Diagnostic Chembio received CE Mark approval for DPP HIV 1/2 Assay to detect HIV infection. Chembio plans to launch the …

    Published on 6/15/2015
  • Drisapersen regulatory update

    BioMarin Pharmaceutical Inc. (NASDAQ:BMRN), Novato, Calif. Product: Drisapersen (2402968) (PRO051, GSK2402968) Business: Musculoskeletal BioMarin submitted an MAA to EMA for drisapersen to treat Duchenne muscular …

    Published on 6/15/2015
  • Dronabinol regulatory update

    Insys Therapeutics Inc. (NASDAQ:INSY), Phoenix, Ariz. Product: Dronabinol Business: Gastrointestinal Insys resubmitted an NDA to FDA for dronabinol to treat anorexia and chemotherapy-induced nausea and vomiting (CINV). …

    Published on 6/15/2015
  • Enclomiphene citrate regulatory update

    Repros Therapeutics Inc. (NASDAQ:RPRX), The Woodlands, Texas Product: Enclomiphene citrate (formerly Androxal) Business: Endocrine/Metabolic FDAs Bone, Reproductive and Urologic Products Advisory Committee will meet on …

    Published on 6/15/2015
  • Galafold migalastat regulatory update

    Amicus Therapeutics Inc. (NASDAQ:FOLD), Cranbury, N.J. Product: Galafold migalastat (AT1001) (formerly Amigal) Business: Endocrine/Metabolic Amicus submitted an MAA to EMA for Galafold migalastat as monotherapy to treat…

    Published on 6/15/2015
  • Grazoprevir/elbasvir regulatory update

    Merck & Co. Inc. (NYSE:MRK), Whitehouse Station, N.J. Product: Grazoprevir/elbasvir (MK-5172/MK-8742) Business: Infectious Merck submitted an NDA to FDA for grazoprevir/elbasvir to treat chronic HCV genotype 1, 4 and 6 …

    Published on 6/15/2015
  • hRPC cells regulatory update

    ReNeuron Group plc (LSE:RENE), Guildford, U.K. Product: hRPC cells (formerly ReN003) Business: Ophthalmic FDA granted Fast Track designation to ReNeurons hRPC cells to treat retinitis pigmentosa (RP). Next half, …

    Published on 6/15/2015
  • Keytruda pembrolizumab regulatory update

    Merck & Co. Inc. (NYSE:MRK), Whitehouse Station, N.J. Product: Keytruda pembrolizumab (MK-3475) (formerly lambrolizumab) Business: Cancer FDA accepted and granted Priority Review to an sBLA from Merck seeking …

    Published on 6/15/2015
  • LentiGlobin BB305 gene therapy regulatory update

    bluebird bio Inc. (NASDAQ:BLUE), Cambridge, Mass. Product: LentiGlobin BB305 gene therapy Business: Hematology NIHs Recombinant DNA Advisory Committee wants bluebird to delay a pediatric trial of its LentiGlobin BB305 …

    Published on 6/15/2015
  • LinkSeq HLA test regulatory update

    Linkage Biosciences Inc., South San Francisco, Calif. Product: LinkSeq HLA test Business: Diagnostic Linkage received CE Mark approval for LinkSeq HLA test to detect human leukocyte antigens (HLA) for use in solid organ…

    Published on 6/15/2015
  • NBI-77860 regulatory update

    Neurocrine Biosciences Inc. (NASDAQ:NBIX), San Diego, Calif. Product: NBI-77860 Business: Endocrine/Metabolic Neurocrine said FDA placed a partial clinical hold on NBI-77860 and that the biotech suspended 2 planned …

    Published on 6/15/2015
  • Opdivo nivolumab regulatory update

    Ono Pharmaceutical Co. Ltd. (Tokyo:4528), Osaka, Japan Bristol-Myers Squibb Co. (NYSE:BMY), New York, N.Y. Product: Opdivo nivolumab (ONO-4538, MDX-1106, BMS-936558) Business: Cancer FDA accepted and granted Priority …

    Published on 6/15/2015
  • Praluent alirocumab regulatory update

    Regeneron Pharmaceuticals Inc. (NASDAQ:REGN), Tarrytown, N.Y. Sanofi (Euronext:SAN; NYSE:SNY), Paris, France Product: Praluent alirocumab (SAR236553, REGN727) Business: Endocrine/Metabolic FDAs Endocrinologic and …

    Published on 6/15/2015
  • RE-024 regulatory update

    Retrophin Inc. (NASDAQ:RTRX), New York, N.Y. Product: RE-024 Business: Neurology FDA granted Fast Track designation to RE-024 from Retrophin to treat pantothenate kinase-associated neurodegeneration (PKAN). The product …

    Published on 6/15/2015
  • Relistor methylnaltrexone regulatory update

    Progenics Pharmaceuticals Inc. (NASDAQ:PGNX), Tarrytown, N.Y. Valeant Pharmaceuticals International Inc. (TSX:VRX; NYSE:VRX), Laval, Quebec Product: Relistor methylnaltrexone (MNTX) (MOA-728, ONO-3849) Business: …

    Published on 6/15/2015
  • Repatha evolocumab regulatory update

    Amgen Inc. (NASDAQ:AMGN), Thousand Oaks, Calif. Product: Repatha evolocumab (AMG 145) Business: Endocrine/Metabolic FDAs Endocrinologic and Metabolic Drugs Advisory Committee voted 15-0 to support approval of Repatha …

    Published on 6/15/2015
  • Variant II Turbo HbA1c Kit 2 regulatory update

    Bio-Rad Laboratories Inc. (NYSE:BIO), Hercules, Calif. Product: Variant II Turbo HbA1c Kit 2.0 Business: Endocrine/Metabolic FDA granted clearance to Bio-Rads Variant II Turbo HbA1c Kit 2.0 as an aid for diagnosing …

    Published on 6/15/2015

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