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Chronological Index of : Regulatory

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  • Avelox moxifloxacin regulatory update

    Bayer AG (Xetra:BAYN), Leverkusen, Germany Product: Avelox moxifloxacin (Actira, Octegra, Avalox) Business: Infectious FDA approved an sNDA from Bayer for Avelox moxifloxacin to treat and prevent plague. The agency …

    Published on 5/18/2015
  • 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 will meet June 11 to discuss a BLA from …

    Published on 5/18/2015
  • Cobiprostone regulatory update

    Sucampo Pharmaceuticals Inc. (NASDAQ:SCMP), Bethesda, Md. Product: Cobiprostone (SPI-8811) (formerly RU-8811) Business: Other FDA granted Fast Track designation to cobiprostone from Sucampo to treat and prevent oral …

    Published on 5/18/2015
  • Flibanserin regulatory update

    Sprout Pharmaceuticals Inc., Raleigh, N.C. Product: Flibanserin (formerly BIMT-17) Business: Genitourinary FDAs Bone, Reproductive and Urologic Drugs and Drug Safety and Risk Management advisory committees will meet on …

    Published on 5/18/2015
  • ND0612H regulatory update

    NeuroDerm Ltd. (NASDAQ:NDRM), Ness Ziona, Israel Product: ND0612H Business: Neurology FDA lifted a clinical hold on NeuroDerms ND0612H and ND0612L to treat Parkinsons disease. The company plans to begin U.S. clinical …

    Published on 5/18/2015
  • ND0612L regulatory update

    NeuroDerm Ltd. (NASDAQ:NDRM), Ness Ziona, Israel Product: ND0612L Business: Neurology FDA lifted a clinical hold on NeuroDerms ND0612H and ND0612L to treat Parkinsons disease. The company plans to begin U.S. clinical …

    Published on 5/18/2015
  • Orkambi ivacaftor/lumacaftor regulatory update

    Vertex Pharmaceuticals Inc. (NASDAQ:VRTX), Boston, Mass. Product: Orkambi ivacaftor/lumacaftor Business: Pulmonary FDAs Pulmonary-Allergy Drugs Advisory Committee voted 12-1 that available efficacy and safety data …

    Published on 5/18/2015
  • RE-024 regulatory update

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

    Published on 5/18/2015
  • SRX-1177 regulatory update

    SolaranRx Inc., Albuquerque, N.M. Product: SRX-1177 Business: Cancer FDA granted Orphan Drug designation to SRX-1177 to treat stage IIB-IV malignant melanoma. SRX-1177 is in preclinical testing. The radiolabeled peptide…

    Published on 5/18/2015
  • Tysabri natalizumab regulatory update

    Biogen Inc. (NASDAQ:BIIB), Cambridge, Mass. Product: Tysabri natalizumab Business: Autoimmune EMAs Pharmacovigilance Risk Assessment Committee (PRAC) began its review to evaluate whether advice given to healthcare …

    Published on 5/18/2015
  • Zykadia ceritinib regulatory update

    Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland Product: Zykadia ceritinib (LDK378) Business: Cancer The European Commission approved Zykadia ceritinib from Novartis to treat advanced anaplastic lymphoma kinase (…

    Published on 5/18/2015
  • 2696273 regulatory update

    San Raffaele Hospital, Milan, Italy GlaxoSmithKline plc (LSE:GSK; NYSE:GSK), London, U.K. Fondazione Telethon, Milan, Italy Product: 2696273, GSK2696273 Business: Endocrine/Metabolic GlaxoSmithKline submitted an MAA to …

    Published on 5/11/2015
  • AR-12 regulatory update

    Arno Therapeutics Inc. (OTCQB:ARNI), Flemington, N.J. Product: AR-12 (formerly OSU-03012) Business: Infectious The European Commission granted Orphan Drug designation to AR-12 from Arno to treat cryptococcosis and …

    Published on 5/11/2015
  • Ionsys fentanyl iontophoretic transdermal system regulatory update

    The Medicines Co. (NASDAQ:MDCO), Parsippany, N.J. Johnson & Johnson (NYSE:JNJ), New Brunswick, N.J. Product: Ionsys fentanyl iontophoretic transdermal system Business: Neurology FDA approved an sNDA from The Medicines …

    Published on 5/11/2015
  • MANF regulatory update

    Amarantus BioScience Holdings Inc. (OTCQB:AMBS), San Francisco, Calif. Product: MANF (Mesencephalic astrocyte-derived neurotrophic factor) (formerly AMRS001) Business: Ophthalmic The European Commission granted Orphan …

    Published on 5/11/2015
  • MBX-8025 regulatory update

    CymaBay Therapeutics Inc. (NASDAQ:CBAY), Newark, Calif. Product: MBX-8025 Business: Endocrine/Metabolic FDA granted Orphan Drug designation to MBX-8025 from CymaBay to treat Type I and V hyperlipoproteinemia. The PPAR …

    Published on 5/11/2015
  • NOxCF regulatory update

    Advanced Inhalation Therapies Ltd., Rehovot, Israel Product: NOxCF, AIT-CF Business: Pulmonary The European Commission granted Orphan Drug designation to AITs AIT-CF to treat cystic fibrosis (CF). The inhaled nitric …

    Published on 5/11/2015
  • 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 5/11/2015
  • 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 5/11/2015
  • Reolysin pelareorep regulatory update

    Oncolytics Biotech Inc. (TSX:ONC; NASDAQ:ONCY), Calgary, Alberta Product: Reolysin pelareorep Business: Cancer The European Commission and FDA granted Orphan Drug designation to Reolysin pelareorep from Oncolytics to …

    Published on 5/11/2015
  • 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 (EMDAC) will meet on June 10 to discuss a …

    Published on 5/11/2015
  • Talimogene laherparepvec regulatory update

    Amgen Inc. (NASDAQ:AMGN), Thousand Oaks, Calif. Product: Talimogene laherparepvec (formerly OncoVEX GM-CSF) Business: Cancer FDAs Cellular, Tissue and Gene Therapies and Oncologic Drugs advisory committees voted 22-1 to…

    Published on 5/11/2015
  • Toviaz fesoterodine regulatory update

    UCB Group (Euronext:UCB), Brussels, Belgium Pfizer Inc. (NYSE:PFE), New York, N.Y. Product: Toviaz fesoterodine Business: Genitourinary FDA granted tentative approval to an ANDA from Amerigen Pharmaceuticals Ltd. (…

    Published on 5/11/2015
  • Tuzistra XR codeine polistirex/chlorpheniramine polistirex regulatory update

    Tris Pharma Inc., Monmouth Junction, N.J. Vernalis plc (LSE:VER), Winnersh, U.K. Product: Tuzistra XR codeine polistirex/chlorpheniramine polistirex (CCP-01) Business: Pulmonary FDA approved an NDA from Tris for …

    Published on 5/11/2015
  • Venetoclax regulatory update

    AbbVie Inc. (NYSE:ABBV), Chicago, Ill. Roche (SIX:ROG; OTCQX:RHHBY), Basel, Switzerland Product: Venetoclax (ABT-199, RG7601) (formerly GDC-0199) Business: Cancer FDA granted breakthrough therapy designation to …

    Published on 5/11/2015

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