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Chronological Index of : Regulatory

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  • AB103 regulatory update

    Atox Bio Inc., Ness Ziona, Israel Product: AB103 Business: Infectious Atox Bio said the European Commission granted Orphan Drug designation to AB103 to treat necrotizing soft tissue infections. The short peptide that …

    Published on 8/18/2014
  • AG-221 regulatory update

    Agios Pharmaceuticals Inc. (NASDAQ:AGIO), Cambridge, Mass. Celgene Corp. (NASDAQ:CELG), Summit, N.J. Product: AG-221 Business: Cancer Agios said FDA granted Fast Track designation to AG-221 to treat acute myelogenous …

    Published on 8/18/2014
  • ALN-AT3 regulatory update

    Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY), Cambridge, Mass. Product: ALN-AT3 Business: Hematology Alnylam said the European Commission granted Orphan Drug designation to ALN-AT3 to treat hemophilia. The RNAi …

    Published on 8/18/2014
  • Bydureon regulatory update

    Alkermes plc (NASDAQ:ALKS), Dublin, Ireland AstraZeneca plc (LSE:AZN; NYSE:AZN), London, U.K. Product: Bydureon (exenatide once weekly) Business: Endocrine/Metabolic AstraZeneca disclosed in its 2Q14 financial results …

    Published on 8/18/2014
  • CombiSNP Array for Pregnancy Loss regulatory update

    CombiMatrix Corp. (NASDAQ:CBMX), Irvine, Calif. Product: CombiSNP Array for Pregnancy Loss Business: Diagnostic CombiMatrix said the New York Department of Health granted conditional approval to the companys CombiSNP …

    Published on 8/18/2014
  • Corifollitropin alfa regulatory update

    Merck & Co. Inc. (NYSE:MRK), Whitehouse Station, N.J. Product: Corifollitropin alfa (Elonva) (SCH 900962, MK-8962) (formerly Org 36286) Business: Endocrine/Metabolic Merck disclosed in its 2Q14 financial results that …

    Published on 8/18/2014
  • Cysteamine bitartrate regulatory update

    Raptor Pharmaceutical Corp. (NASDAQ:RPTP), Novato, Calif. Product: Cysteamine bitartrate (Cysteamine bitartrate delayed-release capsules, Procysbi) (RP103) Business: Neurology The European Commission granted Orphan Drug…

    Published on 8/18/2014
  • E Keppra levetiracetam regulatory update

    UCB Group (Euronext:UCB), Brussels, Belgium Otsuka Pharmaceutical Co. Ltd., Tokyo, Japan Product: E Keppra levetiracetam (Keppra) Business: Neurology Otsuka and UCB announced the submission of a regulatory application …

    Published on 8/18/2014
  • Efient prasugrel regulatory update

    Daiichi Sankyo Co. Ltd. (Tokyo:4568), Tokyo, Japan Eli Lilly and Co. (NYSE:LLY), Indianapolis, Ind. Product: Efient prasugrel (Effient) Business: Cardiovascular The U.K.s NICE published final guidance recommending the …

    Published on 8/18/2014
  • Eliquis apixaban regulatory update

    Bristol-Myers Squibb Co. (NYSE:BMY), New York, N.Y. Pfizer Inc. (NYSE:PFE), New York, N.Y. Product: Eliquis apixaban (BMS-562247-01) Business: Cardiovascular Bristol-Myers Squibb and Pfizer said the European Commission …

    Published on 8/18/2014
  • Eylea aflibercept ophthalmic solution regulatory update

    Regeneron Pharmaceuticals Inc. (NASDAQ:REGN), Tarrytown, N.Y. Bayer AG (Xetra:BAYN), Leverkusen, Germany Product: Eylea aflibercept ophthalmic solution (VEGF Trap-Eye) Business: Ophthalmic The European Commission …

    Published on 8/18/2014
  • Fycompa perampanel regulatory update

    Eisai Co. Ltd. (Tokyo:4523), Tokyo, Japan Product: Fycompa perampanel (E2007) Business: Neurology Germanys Institute for Quality and Efficiency in Healthcare (IQWiG) said Fycompa perampanel from Eisai provides no …

    Published on 8/18/2014
  • GP-101 regulatory update

    Genoa Pharmaceuticals Inc., San Diego, Calif. Product: GP-101 Business: Pulmonary Genoa said FDA granted Orphan Drug designation to the companys inhaled GP-101 an aerosol formulation of pirfenidone to treat idiopathic…

    Published on 8/18/2014
  • Humalog insulin lispro regulatory update

    Eli Lilly and Co. (NYSE:LLY), Indianapolis, Ind. Product: Humalog insulin lispro Business: Endocrine/Metabolic Eli Lilly said EMAs CHMP recommended approval of a higher concentrated formulation 200 units/mL of Humalog…

    Published on 8/18/2014
  • Invokamet regulatory update

    Mitsubishi Tanabe Pharma Corp. (Tokyo:4508), Osaka, Japan Johnson & Johnson (NYSE:JNJ), New Brunswick, N.J. Product: Invokamet ( Vokanamet - EU) canagliflozin/metformin IR Business: Endocrine/Metabolic FDA approved an …

    Published on 8/18/2014
  • Iressa gefitinib regulatory update

    AstraZeneca plc (LSE:AZN; NYSE:AZN), London, U.K. Product: Iressa gefitinib Business: Cancer The U.K.s NICE issued a draft guidance recommending against the use of Iressa gefitinib from AstraZeneca to treat locally …

    Published on 8/18/2014
  • Jakavi ruxolitinib regulatory update

    Incyte Corp. (NASDAQ:INCY), Wilmington, Del. Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland Product: Jakavi ruxolitinib (INCB18424) Business: Hematology Germanys Institute for Quality and Efficiency in Healthcare…

    Published on 8/18/2014
  • Pacritinib regulatory update

    CTI BioPharma Corp. (NASDAQ:CTIC; Milan:CTIC), Seattle, Wash. Baxter International Inc. (NYSE:BAX), Deerfield, Ill. Product: Pacritinib (SB1518, ONX 0803) Business: Hematology CTI said FDA granted Fast Track designation…

    Published on 8/18/2014
  • Plegridy peginterferon beta-1a regulatory update

    Biogen Idec Inc. (NASDAQ:BIIB), Weston, Mass. Product: Plegridy peginterferon beta-1a (BIIB017) Business: Autoimmune FDA approved a BLA from Biogen Idec for Plegridy peginterferon beta-1a to treat relapsing forms of …

    Published on 8/18/2014
  • Procleix HEV assay regulatory update

    Grifols S.A. (Madrid:GRF; NASDAQ:GRFS), Barcelona, Spain Hologic Inc. (NASDAQ:HOLX), Bedford, Mass. Product: Procleix HEV assay Business: Diagnostic Grifols received CE mark approval for its Procleix HEV assay, which …

    Published on 8/18/2014
  • Recombinant LP2086 regulatory update

    Pfizer Inc. (NYSE:PFE), New York, N.Y. Product: Recombinant LP2086 (rLP2086, PF-5212366, PF-05212366) Business: Infectious Pfizer said FDA accepted and granted Priority Review to a BLA for recombinant LP2086 to prevent …

    Published on 8/18/2014
  • Relistor methylnaltrexone regulatory update

    Progenics Pharmaceuticals Inc. (NASDAQ:PGNX), Tarrytown, N.Y. Salix Pharmaceuticals Ltd. (NASDAQ:SLXP), Raleigh, N.C. Ono Pharmaceutical Co. Ltd. (Tokyo:4528), Osaka, Japan Product: Relistor methylnaltrexone (MNTX) (MOA…

    Published on 8/18/2014
  • Remsima infliximab regulatory update

    Celltrion Inc. (KOSDAQ:068270), Incheon, South Korea Nippon Kayaku Co. Ltd. (Tokyo:4272), Tokyo, Japan Product: Remsima infliximab (Inflectra) (CT-P13) Business: Autoimmune Celltrion submitted an application to FDA for …

    Published on 8/18/2014
  • Revlimid lenalidomide regulatory update

    Celgene Corp. (NASDAQ:CELG), Summit, N.J. Product: Revlimid lenalidomide (formerly CDC 501) Business: Cancer The U.K.s NICE issued a second preliminary appraisal recommending against the use of Celgenes Revlimid …

    Published on 8/18/2014
  • Single-agent ribavirin regulatory update

    Pharmascience Inc., Montreal, Quebec Product: Single-agent ribavirin (Ibavyr) Business: Infectious Pharmasciences Pendopharm division said Health Canada approved single-agent Ibavyr ribavirin to treat HCV infection. …

    Published on 8/18/2014

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