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Chronological Index of : Regulatory

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  • Ameluz aminolevulinic acid regulatory update

    Biofrontera AG (Xetra:B8F), Leverkusen, Germany Product: Ameluz aminolevulinic acid (BF-200 ALA) Business: Dermatology The European Commission approved a label expansion for Biofronteras Ameluz aminolevulinic acid to …

    Published on 9/26/2016
  • Aplidin plitidepsin regulatory update

    PharmaMar S.A. (Madrid:PHM), Madrid, Spain Product: Aplidin plitidepsin Business: Cancer PharmaMar submitted an MAA to EMA for Aplidin plitidepsin in combination with dexamethasone to treat relapsed or refractory …

    Published on 9/26/2016
  • Cediranib regulatory update

    AstraZeneca plc (LSE:AZN; NYSE:AZN), London, U.K. Product: Cediranib (Recentin) (AZD2171) Business: Cancer AstraZeneca withdrew an MAA from EMA for cediranib in combination with platinum-based chemotherapy followed by …

    Published on 9/26/2016
  • Chenodeoxycholic acid regulatory update

    Sigma-Tau Group, Pomezia, Italy Product: Chenodeoxycholic acid Business: Endocrine/Metabolic EMAs CHMP recommended approval of chenodeoxycholic acid from Sigma-Tau to treat cerebrotendinous xanthomatosis. The naturally …

    Published on 9/26/2016
  • Exondys 51 eteplirsen regulatory update

    Sarepta Therapeutics Inc. (NASDAQ:SRPT), Cambridge, Mass. Product: Exondys 51 eteplirsen (AVI-4658) Business: Musculoskeletal FDA granted accelerated approval to Exondys 51 eteplirsen from Sarepta to treat Duchenne …

    Published on 9/26/2016
  • Glyxambi empagliflozin/linagliptin regulatory update

    Boehringer Ingelheim GmbH, Ingelheim, Germany Eli Lilly and Co. (NYSE:LLY), Indianapolis, Ind. Product: Glyxambi empagliflozin/linagliptin Business: Endocrine/Metabolic EMAs CHMP recommended approval of Glyxambi …

    Published on 9/26/2016
  • Ibrance palbociclib regulatory update

    Amgen Inc. (NASDAQ:AMGN), Thousand Oaks, Calif. Pfizer Inc. (NYSE:PFE), New York, N.Y. Product: Ibrance palbociclib (PD-0332991) Business: Cancer EMAs CHMP recommended approval of Ibrance palbociclib from Pfizer to …

    Published on 9/26/2016
  • Invokamet XR canagliflozin/metformin extended release regulatory update

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

    Published on 9/26/2016
  • Kisplyx lenvatinib mesylate regulatory update

    Eisai Co. Ltd. (Tokyo:4523), Tokyo, Japan SFJ Pharmaceuticals Inc., Pleasanton, Calif. Product: Kisplyx lenvatinib mesylate (Lenvima) (E7080) Business: Cancer The European Commission approved Kisplyx lenvatinib mesylate…

    Published on 9/26/2016
  • Lartruvo olaratumab regulatory update

    Eli Lilly and Co. (NYSE:LLY), Indianapolis, Ind. Product: Lartruvo olaratumab (IMC-3G3, LY3012207) Business: Cancer EMAs CHMP recommended conditional approval of Lartruvo olaratumab from Eli Lilly in combination with …

    Published on 9/26/2016
  • LentiGlobin BB305 gene therapy regulatory update

    bluebird bio Inc. (NASDAQ:BLUE), Cambridge, Mass. Product: LentiGlobin BB305 gene therapy Business: Hematology EMA granted PRIority MEdicines (PRIME) designation to bluebirds LentiGlobin BB305 gene therapy to treat …

    Published on 9/26/2016
  • Lutathera regulatory update

    Medtronic plc (NYSE:MDT), Dublin, Ireland Advanced Accelerator Applications S.A. (NASDAQ:AAAP), Saint Genis Pouilly, France Product: Lutathera (177Lu-DOTA0-Tyr3-Octreotate, 177-Lu-Dotatate) Business: Cancer Advanced …

    Published on 9/26/2016
  • NBTXR3 regulatory update

    Nanobiotix S.A. (Euronext:NANO), Paris, France Product: NBTXR3, PEP503 Business: Cancer Nanobiotix submitted an application for CE Mark approval in Europe for radioenhancer NBTXR3 for use with radiotherapy to treat …

    Published on 9/26/2016
  • Ninlaro ixazomib regulatory update

    Takeda Pharmaceutical Co. Ltd. (Tokyo:4502), Osaka, Japan Product: Ninlaro ixazomib (MLN9708) Business: Cancer EMAs CHMP recommended conditional approval of Ninlaro ixazomib from Takeda in combination with Revlimid …

    Published on 9/26/2016
  • 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 Bristol-Myers Squibb said EMA …

    Published on 9/26/2016
  • Oral neratinib regulatory update

    Puma Biotechnology Inc. (NYSE:PBYI), Los Angeles, Calif. Pfizer Inc. (NYSE:PFE), New York, N.Y. Product: Oral neratinib (HKI-272, PB272) Business: Cancer FDA accepted for review an NDA from Puma for oral neratinib as an…

    Published on 9/26/2016
  • Parsabiv etelcalcetide regulatory update

    Amgen Inc. (NASDAQ:AMGN), Thousand Oaks, Calif. Ono Pharmaceutical Co. Ltd. (Tokyo:4528), Osaka, Japan Product: Parsabiv etelcalcetide (ONO-5163, AMG 416) (formerly KAI-4169) Business: Endocrine/Metabolic EMAs CHMP …

    Published on 9/26/2016
  • Qapzola apaziquone regulatory update

    Spectrum Pharmaceuticals Inc. (NASDAQ:SPPI), Henderson, Nev. Product: Qapzola apaziquone (EOquin) Business: Cancer FDAs Oncologic Drugs Advisory Committee (ODAC) voted 14-0 that Qapzola apaziquone from Spectrum has not …

    Published on 9/26/2016
  • SomaKit TOC edotreotide regulatory update

    Advanced Accelerator Applications S.A. (NASDAQ:AAAP), Saint Genis Pouilly, France Product: SomaKit TOC edotreotide Business: Diagnostic EMAs CHMP recommended approval of SomaKit TOC edotreotide from Advanced Accelerator…

    Published on 9/26/2016
  • Yuvvexy estradiol VagiCap regulatory update

    TherapeuticsMD Inc. (NYSE-M:TXMD), Boca Raton, Fla. Product: Yuvvexy estradiol VagiCap (TX-004HR) Business: Endocrine/Metabolic FDA accepted for review an NDA from TherapeuticsMD for Yuvvexy to treat moderate to severe …

    Published on 9/26/2016
  • 20% subcutaneous immunoglobulin regulatory update

    Shire plc (LSE:SHP; NASDAQ:SHPG), Dublin, Ireland Product: 20% subcutaneous immunoglobulin (IGSC, Cuvitru)) Business: Hematology FDA approved a BLA for Cuvitru 20% subcutaneous immunoglobulin from Shire to treat primary…

    Published on 9/19/2016
  • Brenzys biosimilar etanercept regulatory update

    Biogen Inc. (NASDAQ:BIIB), Cambridge, Mass. Merck & Co. Inc. (NYSE:MRK), Kenilworth, N.J. Samsung Group, Seoul, South Korea Product: Brenzys biosimilar etanercept (Benepali, SB4) Business: Autoimmune Samsung Bioepis Co.…

    Published on 9/19/2016
  • Brineura cerliponase alfa regulatory update

    BioMarin Pharmaceutical Inc. (NASDAQ:BMRN), San Rafael, Calif. Product: Brineura cerliponase alfa (BMN 190) (formerly BMN-190) Business: Neurology EMA accepted for review an MAA from BioMarin for Brineura cerliponase …

    Published on 9/19/2016
  • Cabometyx cabozantinib regulatory update

    Exelixis Inc. (NASDAQ:EXEL), South San Francisco, Calif. Ipsen Group (Euronext:IPN; Pink:IPSEY), Boulogne-Billancourt, France Product: Cabometyx cabozantinib (Cometriq) (XL184) Business: Cancer The European Commission …

    Published on 9/19/2016
  • Darunavir/cobicistat/emtricitabine/tenofovir alafenamide regulatory update

    Gilead Sciences Inc. (NASDAQ:GILD), Foster City, Calif. Johnson & Johnson (NYSE:JNJ), New Brunswick, N.J. Product: Darunavir/cobicistat/emtricitabine/tenofovir alafenamide Business: Infectious Johnson & Johnsons Janssen…

    Published on 9/19/2016

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