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Chronological Index of : Regulatory

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  • Xarelto rivaroxaban regulatory update

    Bayer AG (Xetra:BAYN), Leverkusen, Germany Product: Xarelto rivaroxaban (BAY 59-7939) Business: Cardiovascular Chinas Food and Drug Administration (CFDA) approved Xarelto rivaroxaban from Bayer for 3 additional …

    Published on 5/11/2015
  • Xpert HIV-1 Qual regulatory update

    Cepheid Inc. (NASDAQ:CPHD), Sunnyvale, Calif. Product: Xpert HIV-1 Qual Business: Diagnostic Cepheid received CE Mark approval for Xpert HIV-1 Qual test to quantitatively detect HIV-1 infection. The company has launched…

    Published on 5/11/2015
  • Abilify aripiprazole regulatory update

    Otsuka Pharmaceutical Co. Ltd., Tokyo, Japan Product: Abilify aripiprazole Business: Neurology FDA approved ANDAs from multiple companies for generic versions of Otsukas Abilify aripiprazole to treat schizophrenia and …

    Published on 5/4/2015
  • Adcetris brentuximab vedotin regulatory update

    Seattle Genetics Inc. (NASDAQ:SGEN), Bothell, Wash. Takeda Pharmaceutical Co. Ltd. (Tokyo:4502), Osaka, Japan Product: Adcetris brentuximab vedotin (SGN-35) Business: Cancer FDA accepted and granted Priority Review to …

    Published on 5/4/2015
  • Aggrastat tirofiban regulatory update

    Medicure Inc. (TSX-V:MPH; OTCQB:MCUJF), Winnipeg, Manitoba Merck & Co. Inc. (NYSE:MRK), Whitehouse Station, N.J. Product: Aggrastat tirofiban Business: Cardiovascular FDA approved a label revision for cardiovascular …

    Published on 5/4/2015
  • AuriPro regulatory update

    Otonomy Inc. (NASDAQ:OTIC), San Diego, Calif. Product: AuriPro (formerly OTO-201) Business: Infectious FDA accepted for review an NDA for AuriPro from Otonomy to treat middle ear effusion in pediatric patients …

    Published on 5/4/2015
  • BAX 855 regulatory update

    Nektar Therapeutics (NASDAQ:NKTR), San Francisco, Calif. Baxter International Inc. (NYSE:BAX), Deerfield, Ill. Product: BAX 855 Business: Hematology Baxter submitted an NDA in Japan for BAX 855 to treat hemophilia A in …

    Published on 5/4/2015
  • Botox onabotulinumtoxinA regulatory update

    Actavis plc (NYSE:ACT), Dublin, Ireland Product: Botox onabotulinumtoxinA (formerly botulinum toxin) Business: Musculoskeletal FDA approved an sBLA for Botox onabotulinumtoxinA from Actavis to treat upper limb …

    Published on 5/4/2015
  • Breo Ellipta fluticasone furoate/vilanterol regulatory update

    Theravance Inc. (NASDAQ:THRX), South San Francisco, Calif. GlaxoSmithKline plc (LSE:GSK; NYSE:GSK), London, U.K. Product: Breo Ellipta fluticasone furoate/vilanterol (Relvar) (GW685698/GW64244) (formerly Relovair) …

    Published on 5/4/2015
  • Bridion sugammadex regulatory update

    Merck & Co. Inc. (NYSE:MRK), Whitehouse Station, N.J. Product: Bridion sugammadex (MK-8616) (formerly Org 25969, SCH 900616) Business: Neurology FDA issued a complete response letter to Merck for an NDA for sugammadex …

    Published on 5/4/2015
  • Brilinta ticagrelor regulatory update

    AstraZeneca plc (LSE:AZN; NYSE:AZN), London, U.K. Product: Brilinta ticagrelor (Brilique-EU) (AZD6140) Business: Cardiovascular FDA accepted and granted Priority Review to an sNDA for Brilinta ticagrelor to prevent …

    Published on 5/4/2015
  • Cabaletta regulatory update

    BioBlast Pharma Ltd. (NASDAQ:ORPN), Tel Aviv, Israel Product: Cabaletta Business: Musculoskeletal FDA granted Fast Track designation to Cabaletta from BioBlast to treat oculopharyngeal muscular dystrophy (OPMD). The …

    Published on 5/4/2015
  • Cannabidiol regulatory update

    GW Pharmaceuticals plc (LSE:GWP; NASDAQ:GWPH), Salisbury, U.K. Product: Cannabidiol (IV GWP42003) Business: Neurology FDA granted Orphan Drug designation to IV GWP42003 from GW to treat neonatal hypoxic-ischemic …

    Published on 5/4/2015
  • Cantrixil regulatory update

    Novogen Ltd. (ASX:NRT; NASDAQ:NVGN), Hornsby, Australia Product: Cantrixil Business: Cancer FDA granted Orphan Drug designation to Novogens Cantrixil to treat ovarian cancer. Cantrixil is a cyclodextrin envelope …

    Published on 5/4/2015
  • CAP-1002 regulatory update

    Capricor Therapeutics Inc. (NASDAQ:CAPR), Beverly Hills, Calif. Johnson & Johnson (NYSE:JNJ), New Brunswick, N.J. Product: CAP-1002 Business: Cardiovascular FDA granted Orphan Drug designation to CAP-1002 from Capricor …

    Published on 5/4/2015
  • Cometriq cabozantinib regulatory update

    Exelixis Inc. (NASDAQ:EXEL), South San Francisco, Calif. Product: Cometriq cabozantinib (XL184) Business: Cancer FDA granted Fast Track designation to Cometriq cabozantinib from Exelixis to treat advanced renal cell …

    Published on 5/4/2015
  • CRLX101 regulatory update

    Arrowhead Research Corp. (NASDAQ:ARWR), Pasadena, Calif. Calando Pharmaceuticals Inc., Pasadena, Calif. Cerulean Pharma Inc. (NASDAQ:CERU), Cambridge, Mass. Product: CRLX101 (formerly IT-101) Business: Cancer FDA …

    Published on 5/4/2015
  • Cyramza ramucirumab regulatory update

    Eli Lilly and Co. (NYSE:LLY), Indianapolis, Ind. Product: Cyramza ramucirumab (LY3009806, IMC-1121B) Business: Cancer FDA approved an sBLA from Eli Lilly for Cyramza ramucirumab to treat metastatic colorectal cancer (…

    Published on 5/4/2015
  • Drisapersen regulatory update

    BioMarin Pharmaceutical Inc. (NASDAQ:BMRN), Novato, Calif. Product: Drisapersen (2402968) (PRO051, GSK2402968) Business: Musculoskeletal BioMarin completed submission of a rolling NDA to FDA for drisapersen to treat …

    Published on 5/4/2015
  • GZ402671 regulatory update

    Sanofi (Euronext:SAN; NYSE:SNY), Paris, France Product: GZ402671, GZ/SAR402671 Business: Endocrine/Metabolic FDA granted Fast Track designation to GZ/SAR402671 from Sanofis Genzyme Corp. company to treat Fabrys disease.…

    Published on 5/4/2015
  • Idarucizumab regulatory update

    Boehringer Ingelheim GmbH, Ingelheim, Germany Product: Idarucizumab (dabigatran antidote) (BI 655075) Business: Hematology FDA accepted and granted Priority Review to a BLA from Boehringer seeking accelerated approval …

    Published on 5/4/2015
  • Irinotecan regulatory update

    Merrimack Pharmaceuticals Inc. (NASDAQ:MACK), Cambridge, Mass. PharmaEngine Inc. (GreTai:4162), Taipei, Taiwan Baxter International Inc. (NYSE:BAX), Deerfield, Ill. Product: Irinotecan (nal-IRI) (PEP02, MM-398) Business…

    Published on 5/4/2015
  • Ixinity trenonacog alfa regulatory update

    Emergent BioSolutions Inc. (NYSE:EBS), Rockville, Md. Product: Ixinity trenonacog alfa (IB1001) Business: Hematology FDA approved a BLA for Ixinity trenonacog alfa from Emergent to control and prevent bleeding episodes …

    Published on 5/4/2015
  • Kybella deoxycholic acid regulatory update

    Kythera Biopharmaceuticals Inc. (NASDAQ:KYTH), Calabasas, Calif. Product: Kybella deoxycholic acid (ATX-101) Business: Other FDA approved an NDA from Kythera for Kybella deoxycholic acid to improve the appearance of …

    Published on 5/4/2015
  • Liposomal Grb-2 regulatory update

    Bio-Path Holdings Inc. (NASDAQ:BPTH), Houston, Texas Product: Liposomal Grb-2 (BP-100-1.01) Business: Cancer FDA granted Orphan Drug designation to Liposomal Grb-2 from Bio-Path to treat acute myelogenous leukemia (AML…

    Published on 5/4/2015

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