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Chronological Index of : Regulatory

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  • Abasria insulin glargine regulatory update

    Boehringer Ingelheim GmbH, Ingelheim, Germany Eli Lilly and Co. (NYSE:LLY), Indianapolis, Ind. Product: Abasria insulin glargine (Basaglar) (LY2963016) Business: Endocrine/Metabolic The European Commission approved …

    Published on 9/15/2014
  • Abraxane nab-paclitaxel regulatory update

    Celgene Corp. (NASDAQ:CELG), Summit, N.J. Taiho Pharmaceutical Co. Ltd., Tokyo, Japan Product: Abraxane nab-paclitaxel (ABI-007) Business: Cancer The U.K.'s NICE issued draft guidance recommending against the use of …

    Published on 9/15/2014
  • Afluria regulatory update

    CSL Ltd. (ASX:CSL), Melbourne, Australia Product: Afluria Business: Infectious CSL's bioCSL Inc. (formerly CSL Biotherapies) subsidiary and PharmaJet Inc. (Golden, Colo.) said FDA approved the PharmaJet Stratis 0.5 mL …

    Published on 9/15/2014
  • Arnuity Ellipta fluticasone furoate regulatory update

    GlaxoSmithKline plc (LSE:GSK; NYSE:GSK), London, U.K. Product: Arnuity Ellipta fluticasone furoate (GW685698) Business: Inflammation FDA approved an NDA from GlaxoSmithKline for Arnuity Ellipta fluticasone furoate as …

    Published on 9/15/2014
  • Betmiga mirabegron regulatory update

    Astellas Pharma Inc. (Tokyo:4503), Tokyo, Japan Product: Betmiga mirabegron (Myrbetriq, Betanis) (YM178) Business: Genitourinary Germany's Institute for Quality and Efficiency in Healthcare (IQWiG) said in a preliminary…

    Published on 9/15/2014
  • Cerenis HDL regulatory update

    Cerenis Therapeutics S.A., Labege, France Product: Cerenis HDL (CER-001) Business: Endocrine/Metabolic Cerenis said the European Commission granted Orphan Drug designation to CER-001 to treat apolipoprotein A-1 (APOA1) …

    Published on 9/15/2014
  • CINtec p16 Histology test regulatory update

    Roche (SIX:ROG; OTCQX:RHHBY), Basel, Switzerland Product: CINtec p16 Histology test Business: Diagnostic Roche's Ventana Medical Systems Inc. unit said the World Health Organization (WHO) issued guidance recommending …

    Published on 9/15/2014
  • Contrave naltrexone SR/bupropion SR regulatory update

    Orexigen Therapeutics Inc. (NASDAQ:OREX), La Jolla, Calif. Product: Contrave naltrexone SR/bupropion SR (NB32) Business: Endocrine/Metabolic FDA approved a resubmitted NDA from Orexigen for Contrave naltrexone/bupropion…

    Published on 9/15/2014
  • Elelyso taliglucerase alfa regulatory update

    Protalix BioTherapeutics Inc. (NYSE-M:PLX; Tel Aviv:PLX), Carmiel, Israel Pfizer Inc. (NYSE:PFE), New York, N.Y. Product: Elelyso taliglucerase alfa (Uplyso alfataliglicerase), (formerly prGCD) Business: Endocrine/…

    Published on 9/15/2014
  • Eloctate regulatory update

    Biogen Idec Inc. (NASDAQ:BIIB), Weston, Mass. Swedish Orphan Biovitrum AB (SSE:SOBI), Stockholm, Sweden UCB Group (Euronext:UCB), Brussels, Belgium Product: Eloctate (RFVIIIFc) Business: Hematology Health Canada …

    Published on 9/15/2014
  • Fluticasone propionate regulatory update

    Prosonix Ltd., Oxford, U.K. Product: Fluticasone propionate (PSX1001) Business: Inflammation Prosonix said the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) accepted for review an MAA for PSX1001 to …

    Published on 9/15/2014
  • IPH4102 regulatory update

    Innate Pharma S.A. (Euronext:IPH), Marseille, France Product: IPH4102 Business: Cancer The European Commission granted Orphan Drug designation to IPH4102 to treat cutaneous T cell lymphoma (CTCL). Next year, Innate …

    Published on 9/15/2014
  • Isavuconazole regulatory update

    Basilea Pharmaceutica AG (SIX:BSLN), Basel, Switzerland Astellas Pharma Inc. (Tokyo:4503), Tokyo, Japan Product: Isavuconazole (BAL8557) Business: Infectious The companies said FDA accepted for review an NDA from …

    Published on 9/15/2014
  • Jetrea ocriplasmin regulatory update

    ThromboGenics N.V. (Euronext:THR), Leuven, Belgium Product: Jetrea ocriplasmin (formerly Microplasmin) Business: Ophthalmic ThromboGenics said South Korea approved Jetrea ocriplasmin to treat vitreomacular adhesion (VMA…

    Published on 9/15/2014
  • Motolimod regulatory update

    VentiRx Pharmaceuticals Inc., Seattle, Wash. Product: Motolimod (VTX-2337) Business: Cancer VentiRx said FDA granted Fast Track designation for motolimod in combination with pegylated liposomal doxorubicin to treat …

    Published on 9/15/2014
  • Natpara regulatory update

    NPS Pharmaceuticals Inc. (NASDAQ:NPSP), Bedminster, N.J. Product: Natpara (Preotact) (NPSP558 (PTH 1-84)) Business: Endocrine/Metabolic FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 8-5 that …

    Published on 9/15/2014
  • Nebivolol/valsartan regulatory update

    Actavis plc (NYSE:ACT), Dublin, Ireland Product: Nebivolol/valsartan Business: Cardiovascular FDA's Cardiovascular and Renal Drugs advisory committee voted 6-4 against approval of an NDA from Actavis for a fixed-dose …

    Published on 9/15/2014
  • NephroCheck test regulatory update

    Astute Medical Inc., San Diego, Calif. Product: NephroCheck test Business: Diagnostic FDA granted 510(k) clearance to Astute's NephroCheck Test System to assess the risk of developing moderate to severe acute kidney …

    Published on 9/15/2014
  • NovoEight turoctocog alfa regulatory update

    Novo Nordisk A/S (CSE:NVO; NYSE:NVO), Bagsvaerd, Denmark Product: NovoEight turoctocog alfa (recombinant FVIII, Novoeight) (NN7008) Business: Hematology Germany's Federal Joint Commission (G-BA) issued a final benefit …

    Published on 9/15/2014
  • Olysio simeprevir regulatory update

    Medivir AB (SSE:MVIR B), Huddinge, Sweden Johnson & Johnson (NYSE:JNJ), New Brunswick, N.J. Product: Olysio simeprevir (Galexos, Sovriad) (TMC435) (formerly TMC435350) Business: Infectious Germany's Institute for …

    Published on 9/15/2014
  • Oral rolapitant regulatory update

    Opko Health Inc. (NYSE:OPK; Tel Aviv:OPK), Miami, Fla. Tesaro Inc. (NASDAQ:TSRO), Waltham, Mass. Product: Oral rolapitant (SCH 619734) Business: Gastrointestinal Tesaro submitted an NDA to FDA for oral rolapitant to …

    Published on 9/15/2014
  • Ozurdex dexamethasone intravitreal implant regulatory update

    Allergan Inc. (NYSE:AGN), Irvine, Calif. Product: Ozurdex dexamethasone intravitreal implant (SK-0503) (formerly Posurdex) Business: Ophthalmic Allergan said the European Commission expanded the label of Ozurdex …

    Published on 9/15/2014
  • PEGPH20 regulatory update

    Halozyme Therapeutics Inc. (NASDAQ:HALO), San Diego, Calif. Product: PEGPH20 (formerly PEGrHuPH20) Business: Cancer Halozyme said that FDA granted Fast Track designation to the company's PEGPH20 in combination with …

    Published on 9/15/2014
  • Relebactam regulatory update

    Merck & Co. Inc. (NYSE:MRK), Whitehouse Station, N.J. Product: Relebactam (MK-7655) Business: Infectious Merck said FDA granted Fast Track and Qualified Infectious Disease Product (QIDP) designations to relebactam to …

    Published on 9/15/2014
  • Subcutaneous RoActemra tocilizumab regulatory update

    Genentech Inc., South San Francisco, Calif. Chugai Pharmaceutical Co. Ltd. (Tokyo:4519), Tokyo, Japan Roche (SIX:ROG; OTCQX:RHHBY), Basel, Switzerland Product: Subcutaneous RoActemra tocilizumab (Subcutaneous Actemra) …

    Published on 9/15/2014

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