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Chronological Index of : Regulatory

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  • Abaloparatide-SC regulatory update

    Ipsen Group (Euronext:IPN; Pink:IPSEY), Boulogne-Billancourt, France Radius Health Inc. (NASDAQ:RDUS), Cambridge, Mass. Teijin Pharma Ltd., Tokyo, Japan Product: Abaloparatide-SC (BA058-SC) (formerly BA058 Injection) …

    Published on 11/23/2015
  • Adynovate regulatory update

    Baxalta Inc. (NYSE:BXLT), Deerfield, Ill. Nektar Therapeutics (NASDAQ:NKTR), San Francisco, Calif. Product: Adynovate (BAX 855) Business: Hematology FDA approved a BLA from Baxalta for Adynovate to prevent and control …

    Published on 11/23/2015
  • Avelumab regulatory update

    Merck KGaA (Xetra:MRK), Darmstadt, Germany Pfizer Inc. (NYSE:PFE), New York, N.Y. Product: Avelumab (MSB0010718C) Business: Cancer FDA granted breakthrough therapy designation to avelumab from Merck to treat metastatic …

    Published on 11/23/2015
  • Bilastine regulatory update

    Faes Farma S.A., Madrid, Spain Taiho Pharmaceutical Co. Ltd., Tokyo, Japan Product: Bilastine (TAC-202) Business: Inflammation Taiho submitted an NDA in Japan for bilastine to treat allergic rhinitis, urticaria and …

    Published on 11/23/2015
  • Buprenorphine regulatory update

    Braeburn Pharmaceuticals S.p.r.l., Princeton, N.J. Camurus AB, Lund, Sweden Product: Buprenorphine (CAM2038) Business: Neurology FDA granted Fast Track designation for weekly and monthly subcutaneous buprenorphine from …

    Published on 11/23/2015
  • CardioCel regulatory update

    Admedus Ltd. (ASX:AHZ), Perth, Australia Product: CardioCel Business: Transplant Admedus said CardioCel is now approved in Europe for use in the repair and reconstruction of heart valves. The product is also approved to…

    Published on 11/23/2015
  • Cosentyx secukinumab regulatory update

    Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland Product: Cosentyx secukinumab (formerly AIN457) Business: Autoimmune EMAs CHMP recommended approval of a label expansion for Cosentyx secukinumab from Novartis to …

    Published on 11/23/2015
  • Cotellic cobimetinib regulatory update

    Exelixis Inc. (NASDAQ:EXEL), South San Francisco, Calif. Genentech Inc., South San Francisco, Calif. Roche (SIX:ROG; OTCQX:RHHBY), Basel, Switzerland Product: Cotellic cobimetinib (RG7421, GDC-0973) (formerly XL518) …

    Published on 11/23/2015
  • Darzalex daratumumab regulatory update

    Genmab A/S (CSE:GEN; Pink:GMXAY), Copenhagen, Denmark Johnson & Johnson (NYSE:JNJ), New Brunswick, N.J. Product: Darzalex daratumumab (HuMax-CD38) Business: Cancer FDA granted accelerated approval to Darzalex …

    Published on 11/23/2015
  • Epi proColon regulatory update

    Epigenomics AG (Xetra:ECX; OTCQX:EPGNY), Berlin, Germany Product: Epi proColon (formerly Epi proColon 2.0) Business: Diagnostic Epigenomics received a response letter from FDA for a PMA for the Epi proColon blood-based …

    Published on 11/23/2015
  • Genvoya tenofovir alafenamide fumarate regulatory update

    Gilead Sciences Inc. (NASDAQ:GILD), Foster City, Calif. Product: Genvoya tenofovir alafenamide fumarate (TAF)/elvitegravir/cobicistat/emtricitabine Business: Infectious FDA approved an NDA from Gilead for Genvoya …

    Published on 11/23/2015
  • Imbruvica ibrutinib regulatory update

    AbbVie Inc. (NYSE:ABBV), Chicago, Ill. Johnson & Johnson (NYSE:JNJ), New Brunswick, N.J. Product: Imbruvica ibrutinib (PCI-32765) Business: Cancer Johnson & Johnsons Janssen-Cilag International N.V. unit submitted an …

    Published on 11/23/2015
  • Kalydeco ivacaftor regulatory update

    Vertex Pharmaceuticals Inc. (NASDAQ:VRTX), Boston, Mass. Product: Kalydeco ivacaftor (VX-770) Business: Pulmonary The European Commission approved a label expansion for Kalydeco ivacaftor from Vertex to treat cystic …

    Published on 11/23/2015
  • LA-EP2006 regulatory update

    Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland Product: LA-EP2006 Business: Hematology FDA accepted for review a BLA from Novartis Sandoz Inc. generics unit for LA-EP2006, a biosimilar of neutropenia drug Neulasta…

    Published on 11/23/2015
  • Letairis regulatory update

    Gilead Sciences Inc. (NASDAQ:GILD), Foster City, Calif. GlaxoSmithKline plc (LSE:GSK; NYSE:GSK), London, U.K. Product: Letairis ( Volibris - EU) ambrisentan Business: Cardiovascular EMAs CHMP recommended approval of a …

    Published on 11/23/2015
  • MCNA regulatory update

    Telesta Therapeutics Inc. (TSX:TST; Pink:BNHLF), Belleville, Ontario Product: MCNA (EN3348) (formerly Urocidin) Business: Cancer FDAs Cellular, Tissue and Gene Therapies and Oncologic Drugs advisory committees voted 18-…

    Published on 11/23/2015
  • Narcan naloxone regulatory update

    Adapt Pharma Ltd., Dublin, Ireland Lightlake Therapeutics Inc. (OTCBB:LLTP), London, U.K. Product: Narcan naloxone Business: Neurology FDA approved Narcan naloxone nasal spray for the emergency treatment of known or …

    Published on 11/23/2015
  • NT-0102 regulatory update

    Neos Therapeutics Inc. (NASDAQ:NEOS), Grand Prairie, Texas Product: NT-0102 (Cotempla XR-ODT) Business: Neurology FDA issued a complete response letter to Neos for Cotempla XR-ODT to treat ADHD. In the letter, Neos said…

    Published on 11/23/2015
  • Obizur susoctocog alfa regulatory update

    Baxalta Inc. (NYSE:BXLT), Deerfield, Ill. Product: Obizur susoctocog alfa () OBI-1) Business: Hematology The European Commission approved an MAA from Baxalta for Obizur susoctocog alfa from Baxalta to treat bleeding …

    Published on 11/23/2015
  • 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 11/23/2015
  • Oral ANAVEX 2-73 regulatory update

    Anavex Life Sciences Corp. (NASDAQ:AVXL), New York, N.Y. Product: Oral ANAVEX 2-73 Business: Neurology Anavex said it is planning a double-blind, placebo-controlled Phase II/III trial of ANAVEX 2-73 to treat Alzheimers …

    Published on 11/23/2015
  • PIFA Heparin/PF4 rapid assay regulatory update

    Akers Biosciences Inc. (NASDAQ:AKER; LSE:AKR), Thorofare, N.J. Product: PIFA Heparin/PF4 rapid assay Business: Diagnostic The China Food and Drug Administration (CFDA) approved Akers PIFA Heparin/PF4 Rapid Assay to test…

    Published on 11/23/2015
  • Plavix clopidogrel regulatory update

    Bristol-Myers Squibb Co. (NYSE:BMY), New York, N.Y. Sanofi (Euronext:SAN; NYSE:SNY), Paris, France Product: Plavix clopidogrel Business: Cardiovascular FDA said that long-term use of Plavix clopidogrel from Sanofi and …

    Published on 11/23/2015
  • Rizatriptan regulatory update

    IntelGenx Corp. (TSX-V:IGX; OTCQX:IGXT), Saint-Laurent, Quebec RedHill Biopharma Ltd. (Tel Aviv:RDHL; NASDAQ:RDHL), Ramat Gan, Israel Product: Rizatriptan (Rizaport) (RHB-103) Business: Neurology Germany approved …

    Published on 11/23/2015
  • Rociletinib regulatory update

    Celgene Corp. (NASDAQ:CELG), Summit, N.J. Clovis Oncology Inc. (NASDAQ:CLVS), Boulder, Colo. Product: Rociletinib (AVL-301) (formerly CO-1686) Business: Cancer Clovis said the rate of confirmed responses to rociletinib …

    Published on 11/23/2015

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