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Chronological Index of : Regulatory

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  • Pomalyst pomalidomide regulatory update

    Celgene Corp. (NASDAQ:CELG), Summit, N.J. Product: Pomalyst pomalidomide (Imnovid - EU) (CC-4047) Business: Cancer Japan approved Pomalyst pomalidomide from Celgene to treat relapsed or refractory multiple myeloma (MM)…

    Published on 4/13/2015
  • Repatha evolocumab regulatory update

    Amgen Inc. (NASDAQ:AMGN), Thousand Oaks, Calif. Astellas Pharma Inc. (Tokyo:4503), Tokyo, Japan Product: Repatha evolocumab (AMG 145) Business: Endocrine/Metabolic Amgen submitted an NDA in Japan for Repatha evolocumab …

    Published on 4/13/2015
  • Ryzodeg insulin degludec/insulin aspart regulatory update

    Novo Nordisk A/S (CSE:NVO; NYSE:NVO), Bagsvaerd, Denmark Product: Ryzodeg insulin degludec/insulin aspart (DegludecPlus, IDegAsp) (NN5401) Business: Endocrine/Metabolic Novo Nordisk said FDA accepted for review 2 …

    Published on 4/13/2015
  • Sanguinate regulatory update

    Prolong Pharmaceuticals LLC, South Plainfield, N.J. Product: Sanguinate Business: Hematology Prolong said FDA granted Orphan Drug designation to Sanguinate to treat sickle cell disease (SCD). Sanguinate is a pegylated …

    Published on 4/13/2015
  • SHP465 triple-bead MAS regulatory update

    Shire plc (LSE:SHP; NASDAQ:SHPG), Dublin, Ireland Product: SHP465 triple-bead MAS (formerly SPD465) Business: Neurology Shire said it now expects to resubmit an NDA in 2Q17 for SHP465 to treat ADHD in adults. The …

    Published on 4/13/2015
  • Soolantra ivermectin 1% regulatory update

    Galderma S.A., Lausanne, Switzerland Product: Soolantra ivermectin 1% (CD5024 1%) Business: Dermatology Galderma said once-daily Soolantra ivermectin 1% cream was approved to treat inflammatory lesions of papulopustular…

    Published on 4/13/2015
  • STP206 regulatory update

    Sigma-Tau Group, Pomezia, Italy Product: STP206, STP-206 Business: Gastrointestinal FDA granted Orphan Drug designation to STP-206 from Sigma-Tau to prevent necrotizing enterocolitis in premature infants with a birth …

    Published on 4/13/2015
  • Sustiva efavirenz regulatory update

    Merck & Co. Inc. (NYSE:MRK), Whitehouse Station, N.J. Product: Sustiva efavirenz (DMP 266) Business: Infectious EMAs CHMP recommended approval of an expanded label for Mercks Sustiva efavirenz to treat HIV-1 infection …

    Published on 4/13/2015
  • Tamiflu oseltamivir regulatory update

    Gilead Sciences Inc. (NASDAQ:GILD), Foster City, Calif. Chugai Pharmaceutical Co. Ltd. (Tokyo:4519), Tokyo, Japan Roche (SIX:ROG; OTCQX:RHHBY), Basel, Switzerland Product: Tamiflu oseltamivir Business: Infectious EMAs …

    Published on 4/13/2015
  • Toujeo insulin glargine regulatory update

    Sanofi (Euronext:SAN; NYSE:SNY), Paris, France Product: Toujeo insulin glargine (formerly U300) Business: Endocrine/Metabolic EMAs CHMP recommended approval of Toujeo insulin glargine to treat adult Type I and II …

    Published on 4/13/2015
  • Tresiba insulin degludec regulatory update

    Novo Nordisk A/S (CSE:NVO; NYSE:NVO), Bagsvaerd, Denmark Product: Tresiba insulin degludec (NN1250) Business: Endocrine/Metabolic Novo Nordisk said FDA accepted for review 2 resubmitted NDAs for Tresiba insulin degludec…

    Published on 4/13/2015
  • Zinbryta daclizumab high-yield process regulatory update

    Biogen Inc. (NASDAQ:BIIB), Cambridge, Mass. UCB Group (Euronext:UCB), Brussels, Belgium AbbVie Inc. (NYSE:ABBV), Chicago, Ill. Product: Zinbryta daclizumab high-yield process (DAC HYP) Business: Autoimmune EMA accepted …

    Published on 4/13/2015
  • Amigal migalastat regulatory update

    Amicus Therapeutics Inc. (NASDAQ:FOLD), Cranbury, N.J. Product: Amigal migalastat (AT1001) Business: Endocrine/Metabolic Amicus said it will submit an MAA to EMA this quarter and an NDA to FDA next half for Amigal …

    Published on 4/6/2015
  • AmpliVue Trichomonas Assay regulatory update

    Quidel Corp. (NASDAQ:QDEL), San Diego, Calif. Product: AmpliVue Trichomonas Assay Business: Diagnostic FDA granted 510(k) clearance for Quidels AmpliVue Trichomonas Assay to diagnose trichomoniasis from vaginal swabs …

    Published on 4/6/2015
  • Cerdelga eliglustat tartrate regulatory update

    Sanofi (Euronext:SAN; NYSE:SNY), Paris, France Product: Cerdelga eliglustat tartrate (formerly Genz-112638) Business: Endocrine/Metabolic Sanofis Genzyme Corp. unit said Japan approved Cerdelga eliglustat to treat Type …

    Published on 4/6/2015
  • EBV-CTL regulatory update

    Memorial Sloan Kettering Cancer Center, New York, N.Y. Product: EBV-CTL Business: Cancer Atara Biotherapeutics Inc. (NASDAQ:ATRA, Brisbane, Calif.) said FDA granted breakthrough therapy designation to EBV-CTL from …

    Published on 4/6/2015
  • Factor IX-albumin fusion protein regulatory update

    CSL Ltd. (ASX:CSL), Melbourne, Australia Product: Factor IX-albumin fusion protein, rIX-FP (CSL654) Business: Hematology CSLs CSL Behring said EMA accepted for review an MAA for rIX-FP for hemophilia B. The product is …

    Published on 4/6/2015
  • Ganaxolone regulatory update

    Marinus Pharmaceuticals Inc. (NASDAQ:MRNS), Radnor, Pa. Product: Ganaxolone (CCD-1042) Business: Neurology FDA granted Orphan Drug designation to ganaxolone from Marinus to treat epilepsy in females with a mutation in …

    Published on 4/6/2015
  • Harvoni ledipasvir regulatory update

    Gilead Sciences Inc. (NASDAQ:GILD), Foster City, Calif. Product: Harvoni ledipasvir (GS-5885)/sofosbuvir (GS-7977) Business: Infectious FDA issued a drug safety alert warning of symptomatic bradycardia when the …

    Published on 4/6/2015
  • Incruse Ellipta umeclidinium bromide regulatory update

    GlaxoSmithKline plc (LSE:GSK; NYSE:GSK), London, U.K. Product: Incruse Ellipta umeclidinium bromide (Encruse Ellipta) Business: Pulmonary Japan approved Encruse Ellipta umeclidinium bromide from GlaxoSmithKline to treat…

    Published on 4/6/2015
  • Jakafi ruxolitinib regulatory update

    Incyte Corp. (NASDAQ:INCY), Wilmington, Del. Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland Product: Jakafi ruxolitinib (Jakavi-EU) (INCB18424) Business: Hematology The European Commission approved Jakavi …

    Published on 4/6/2015
  • Kalydeco ivacaftor regulatory update

    Vertex Pharmaceuticals Inc. (NASDAQ:VRTX), Boston, Mass. Royalty Pharma, New York, N.Y. Product: Kalydeco ivacaftor (VX-770) Business: Pulmonary FDA approved an expanded label for Kalydeco ivacaftor to treat cystic …

    Published on 4/6/2015
  • Masican masitinib regulatory update

    AB Science S.A. (Euronext:AB), Paris, France Product: Masican masitinib (AB1010) Business: Neurology FDA granted Orphan Drug designation to masitinib from AB Science to treat amyotrophic lateral sclerosis. The stem cell…

    Published on 4/6/2015
  • 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 homozygous familial hypercholesterolemia (…

    Published on 4/6/2015
  • MiR-21 regulatory update

    Regulus Therapeutics Inc. (NASDAQ:RGLS), San Diego, Calif. Product: MiR-21 (anti-miR-21) (RG-012) (formerly antagomir-21) Business: Renal The European Commission granted Orphan Drug designation to RG-012 from Regulus to…

    Published on 4/6/2015

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