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Chronological Index of : Regulatory

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  • 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 Molecular target: Tubulin Description: Albumin stabilized nanoparticle …

    Published on 11/17/2014
  • AMY-101 regulatory update

    Amyndas Phamaceuticals LLC, Philadlephia, Pa. Product: AMY-101 Business: Hematology Molecular target: Complement 3 (C3) Description: Compstatin-derived complement 3 (C3) inhibitor Indication: Treat paroxysmal nocturnal …

    Published on 11/17/2014
  • Avastin bevacizumab regulatory update

    Genentech Inc., South San Francisco, Calif. Chugai Pharmaceutical Co. Ltd. (Tokyo:4519), Tokyo, Japan Roche (SIX:ROG; OTCQX:RHHBY), Basel, Switzerland Product: Avastin bevacizumab (RG435) Business: Cancer Molecular …

    Published on 11/17/2014
  • Evolocumab regulatory update

    Amgen Inc. (NASDAQ:AMGN), Thousand Oaks, Calif. Astellas Pharma Inc. (Tokyo:4503), Tokyo, Japan Product: Evolocumab (AMG 145) Business: Endocrine/Metabolic Molecular target: Proprotein convertase subtilisin/kexin type 9…

    Published on 11/17/2014
  • Flubok regulatory update

    Protein Sciences Corp., Meriden, Conn. UMN Pharma Inc. (Tokyo:4585), Akita, Japan Astellas Pharma Inc. (Tokyo:4503), Tokyo, Japan Ildong Pharmaceutical Co. Ltd. (KSE:000230), Seoul, South Korea Product: Flubok (UMN-0502…

    Published on 11/17/2014
  • Isavuconazole regulatory update

    Basilea Pharmaceutica AG (SIX:BSLN), Basel, Switzerland Astellas Pharma Inc. (Tokyo:4503), Tokyo, Japan Product: Isavuconazole (BAL8557) Business: Infectious Molecular target: 14 alpha-sterol demethylase Description: …

    Published on 11/17/2014
  • MM-141 regulatory update

    Merrimack Pharmaceuticals Inc. (NASDAQ:MACK), Cambridge, Mass. Product: MM-141 Business: Cancer Molecular target: Epidermal growth factor receptor 3 (EGFR3) (HER3) (ErbB3); Insulin-like growth factor-1 (IGF-1) receptor…

    Published on 11/17/2014
  • Patrome regulatory update

    Impax Laboratories Inc. (NASDAQ:IPXL), Hayward, Calif. Product: Patrome (Rytary) (GSK587124, IPX066) Business: Neurology Molecular target: Not available Description: Extended-release combination of carbidopa and …

    Published on 11/17/2014
  • Remicade infliximab regulatory update

    Johnson & Johnson (NYSE:JNJ), New Brunswick, N.J. Product: Remicade infliximab (formerly TA-650) Business: Inflammation Molecular target: Tumor necrosis factor (TNF) alpha Description: Chimeric mAb against tumor …

    Published on 11/17/2014
  • Rivastach Patch rivastigmine regulatory update

    Ono Pharmaceutical Co. Ltd. (Tokyo:4528), Osaka, Japan Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland Product: Rivastach Patch rivastigmine (Exelon Patch ) Business: Neurology Molecular target: …

    Published on 11/17/2014
  • RST-001 regulatory update

    RetroSense Therapeutics LLC, Ann Arbor, Mich. Product: RST-001 Business: Ophthalmic Molecular target: NA Description: Adeno-associated virus (AAV) 2 vector activating the channelrhodopsin-2 gene Indication: Treat …

    Published on 11/17/2014
  • AAV2-hRPE65v2 regulatory update

    Spark Therapeutics LLC, Philadelphia, Pa. Product: AAV2-hRPE65v2, SPK-RPE65 Business: Ophthalmic FDA granted breakthrough therapy designation to SPK-RPE65 from Spark to treat nyctalopia (night blindness) in patients …

    Published on 11/10/2014
  • ARA 290 regulatory update

    Araim Pharmaceuticals Inc., Ossining, N.Y. Product: ARA 290 Business: Inflammation FDA granted Fast Track designation to Araim's ARA 290 to treat sarcoidosis-associated small fiber neuropathy. The short tissue …

    Published on 11/10/2014
  • Arzerra ofatumumab regulatory update

    Genmab A/S (CSE:GEN; OTCBB:GMXAY), Copenhagen, Denmark GlaxoSmithKline plc (LSE:GSK; NYSE:GSK), London, U.K. Product: Arzerra ofatumumab (HuMax-CD20) Business: Cancer The U.K.'s NICE issued preliminary draft guidance …

    Published on 11/10/2014
  • CLT-28643 regulatory update

    Clanotech AB, Solna, Sweden Product: CLT-28643 Business: Ophthalmic The European Commission granted Orphan Drug designation to CLT-28643 from Clanotech to prevent scarring following glaucoma filtration surgery. The …

    Published on 11/10/2014
  • DNX-2401 regulatory update

    DNAtrix Inc., Houston, Texas Product: DNX-2401 Business: Cancer FDA granted Orphan Drug designation to DNX-2401 from DNAtrix to treat malignant glioma. DNX-2401 is in Phase I testing for recurrent malignant glioma and …

    Published on 11/10/2014
  • Duavive conjugated estrogens/bazedoxifene regulatory update

    Ligand Pharmaceuticals Inc. (NASDAQ:LGND), La Jolla, Calif. Pfizer Inc. (NYSE:PFE), New York, N.Y. Product: Duavive conjugated estrogens/bazedoxifene (CE/BZA) (Duavee) Business: Endocrine/Metabolic EMA's CHMP …

    Published on 11/10/2014
  • Eloctate RFVIIIFc 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 (Elocta) Business: Hematology EMA accepted …

    Published on 11/10/2014
  • Faradyk panobinostat regulatory update

    Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland Product: Faradyk panobinostat (LBH589) Business: Cancer FDA's Oncologic Drugs Advisory Committee voted 5-2 that the progression-free survival (PFS) benefit of Farydak…

    Published on 11/10/2014
  • Hemopurifier regulatory update

    Aethlon Medical Inc. (OTCQB:AEMD), San Diego, Calif. Product: Hemopurifier Business: Infectious Aethlon will provide its Hemopurifier under a compassionate use program in the U.S. to treat Ebola infection. Aethlon plans…

    Published on 11/10/2014
  • Intranasal sumatriptan powder regulatory update

    Avanir Pharmaceuticals Inc. (NASDAQ:AVNR), Aliso Viejo, Calif. OptiNose Inc., Yardley, Pa. Product: Intranasal sumatriptan powder, OptiNose sumatriptan (AVP-825) Business: Neurology On Nov. 7, Avanir said FDA is "…

    Published on 11/10/2014
  • Ivacaftor/VX-809 regulatory update

    Vertex Pharmaceuticals Inc. (NASDAQ:VRTX), Boston, Mass. Product: Ivacaftor/VX-809 (ivacaftor/lumacaftor) Business: Pulmonary Vertex submitted an NDA to FDA and an MAA to EMA for the combination of 250 mg Kalydeco …

    Published on 11/10/2014
  • Maestro Rechargeable regulatory update

    EnteroMedics Inc. (NASDAQ:ETRM), St. Paul, Minn. Product: Maestro Rechargeable (RC) System Business: Endocrine/Metabolic EnteroMedics said it received CE Mark approval for its Maestro Rechargeable System to manage Type …

    Published on 11/10/2014
  • Mepolizumab regulatory update

    GlaxoSmithKline plc (LSE:GSK; NYSE:GSK), London, U.K. Product: Mepolizumab (Bosatria) (SB-240563) Business: Inflammation GlaxoSmithKline submitted a BLA to FDA and an MAA to EMA for mepolizumab as a maintenance …

    Published on 11/10/2014
  • NKTT120 regulatory update

    NKT Therapeutics Inc., Waltham, Mass. Product: NKTT120 Business: Hematology FDA granted Fast Track designation to NKTT120 from NKT to treat sickle cell disease. Next year, the company plans to start Phase IIb testing of…

    Published on 11/10/2014

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