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Chronological Index of : Regulatory

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  • Rociletinib regulatory update

    Celgene Corp. (NASDAQ:CELG), Summit, N.J. Clovis Oncology Inc. (NASDAQ:CLVS), Boulder, Colo. Product: Rociletinib (AVL-301) (formerly CO-1686) Business: Cancer FDA and EMA accepted regulatory applications for …

    Published on 10/5/2015
  • 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 FDA approved NDAs from Novo Nordisk for Tresiba …

    Published on 10/5/2015
  • Translarna ataluren regulatory update

    PTC Therapeutics Inc. (NASDAQ:PTCT), South Plainfield, N.J. Product: Translarna ataluren (formerly PTC124) Business: Pulmonary EMA accepted for review a regulatory application from PTC Therapeutics for Translarna …

    Published on 10/5/2015
  • Tresiba insulin degludec regulatory update

    Novo Nordisk A/S (CSE:NVO; NYSE:NVO), Bagsvaerd, Denmark Product: Tresiba insulin degludec (NN1250) Business: Endocrine/Metabolic FDA approved NDAs from Novo Nordisk for Tresiba insulin degludec and Ryzodeg insulin …

    Published on 10/5/2015
  • Yervoy ipilimumab regulatory update

    Ono Pharmaceutical Co. Ltd. (Tokyo:4528), Osaka, Japan Bristol-Myers Squibb Co. (NYSE:BMY), New York, N.Y. Product: Yervoy ipilimumab (BMS-734016) Business: Cancer Bristol-Myers Squibb said FDA granted accelerated …

    Published on 10/5/2015
  • Arzerra ofatumumab regulatory update

    Genmab A/S (CSE:GEN; OTCBB:GMXAY), Copenhagen, Denmark Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland Product: Arzerra ofatumumab (HuMax-CD20) Business: Cancer FDA has accepted and granted Priority Review to an …

    Published on 9/28/2015
  • BC-819 regulatory update

    BioCancell Therapeutics Inc. (Tel Aviv:BICL), Jerusalem, Israel Product: BC-819 Business: Cancer FDA granted Fast Track designation to BioCancells BC-819 to treat bladder cancer. Next half, the company plans to start 2 …

    Published on 9/28/2015
  • Bridion sugammadex regulatory update

    Merck & Co. Inc. (NYSE:MRK), Kenilworth, N.J. Product: Bridion sugammadex (MK-8616) (formerly Org 25969, SCH 900616) Business: Neurology FDAs Anesthetic and Analgesic Drug Products Advisory Committee will meet on Nov. 6…

    Published on 9/28/2015
  • Cobas Influenza A/B test regulatory update

    Roche (SIX:ROG; OTCQX:RHHBY), Basel, Switzerland Product: Cobas Influenza A/B test Business: Diagnostic FDA granted a CLIA waiver to the cobas Influenza A/B test from Roche for use on the cobas Liat System to detect and…

    Published on 9/28/2015
  • Granisetron extended release regulatory update

    Heron Therapeutics Inc. (NASDAQ:HRTX), Redwood City, Calif. Product: Granisetron extended release (Sustol) (APF530) Business: Gastrointestinal FDA accepted for review an NDA from Heron for Sustol granisetron extended …

    Published on 9/28/2015
  • GynTect regulatory update

    oncgnostics GmbH, Jena, Germany MDxHealth S.A. (Euronext:MDXH), Liege, Belgium Product: GynTect Business: Diagnostic oncgnostics received CE Mark approval for GynTect to detect cervical precancerous lesions and cancer. …

    Published on 9/28/2015
  • Imbruvica ibrutinib regulatory update

    AbbVie Inc. (NYSE:ABBV), Chicago, Ill. Johnson & Johnson (NYSE:JNJ), New Brunswick, N.J. Product: Imbruvica ibrutinib (PCI-32765) Business: Cancer AbbVie submitted an sNDA to FDA for Imbruvica ibrutinib for first-line …

    Published on 9/28/2015
  • Infliximab regulatory update

    Celltrion Inc. (KOSDAQ:068270), Incheon, South Korea Hospira Inc. (NYSE:HSP), Lake Forest, Ill. Product: Infliximab (Remsima, Inflectra) (CT-P13) Business: Autoimmune Australia approved Inflectra infliximab, a …

    Published on 9/28/2015
  • Intuniv guanfacine extended release regulatory update

    Shire plc (LSE:SHP; NASDAQ:SHPG), Dublin, Ireland Product: Intuniv guanfacine extended release (S-877503) Business: Neurology The European Commission approved an MAA from Shire for once-daily Intuniv guanfacine extended…

    Published on 9/28/2015
  • Invokamet regulatory update

    Mitsubishi Tanabe Pharma Corp. (Tokyo:4508), Osaka, Japan Johnson & Johnson (NYSE:JNJ), New Brunswick, N.J. Product: Invokamet (Vokanamet - EU) canagliflozin/metformin IR (Vokanamet ) Business: Endocrine/Metabolic FDA …

    Published on 9/28/2015
  • Invokana canagliflozin regulatory update

    Mitsubishi Tanabe Pharma Corp. (Tokyo:4508), Osaka, Japan Johnson & Johnson (NYSE:JNJ), New Brunswick, N.J. Product: Invokana canagliflozin (Canaglu) (TA-7284, JNJ-28431754) Business: Endocrine/Metabolic FDA …

    Published on 9/28/2015
  • Kyprolis carfilzomib regulatory update

    Amgen Inc. (NASDAQ:AMGN), Thousand Oaks, Calif. Product: Kyprolis carfilzomib (PR-171, ONO-7057) Business: Cancer FDA accepted and granted Priority Review to an sNDA from Amgen for Kyprolis carfilzomib to treat relapsed…

    Published on 9/28/2015
  • Lonsurf trifluridine/tipiracil regulatory update

    Servier, Neuilly-sur-Seine, France Taiho Pharmaceutical Co. Ltd., Tokyo, Japan Product: Lonsurf trifluridine/tipiracil (TAS-102) Business: Cancer FDA approved an NDA from Taiho for Lonsurf trifluridine/tipiracil to …

    Published on 9/28/2015
  • MCNA regulatory update

    Telesta Therapeutics Inc. (TSX:TST; Pink:BNHLF), Belleville, Ontario Product: MCNA (EN3348) (formerly Urocidin) Business: Cancer FDAs Cellular, Tissue and Gene Therapies and Oncologic Drugs advisory committees will meet…

    Published on 9/28/2015
  • Mesenchymal precursor cells regulatory update

    JCR Pharmaceuticals Co. Ltd. (Tokyo:4552), Ashiya, Japan Mesoblast Ltd. (ASX:MSB; Pink:MBLTY), Melbourne, Australia Product: Mesenchymal precursor cells (MPC) (Temcell) (JR-031) Business: Transplant Japan approved an …

    Published on 9/28/2015
  • Mitizax regulatory update

    ALK-Abello A/S (CSE:ALK-B), Horsholm, Denmark Product: Mitizax (house dust mite (HDM) sublingual allergy immunotherapy (SLIT)) (MK-8237, TO-203) Business: Inflammation ALK-Abellos house dust mite (HDM) sublingual …

    Published on 9/28/2015
  • Nucala mepolizumab regulatory update

    GlaxoSmithKline plc (LSE:GSK; NYSE:GSK), London, U.K. Product: Nucala mepolizumab (SB-240563) (formerly Bosatria) Business: Inflammation EMAs CHMP recommended approval of Nucala mepolizumab as an add-on treatment for …

    Published on 9/28/2015
  • Probuphine buprenorphine regulatory update

    Braeburn Pharmaceuticals S.p.r.l., Princeton, N.J. Titan Pharmaceuticals Inc. (OTCBB:TTNP), South San Francisco, Calif. Product: Probuphine buprenorphine Business: Neurology Braeburn resubmitted an NDA to FDA for …

    Published on 9/28/2015
  • Reslizumab regulatory update

    Teva Pharmaceutical Industries Ltd. (NYSE:TEVA), Petah Tikva, Israel Product: Reslizumab (formerly Cinquil) Business: Inflammation FDAs Pulmonary-Allergy Drugs Advisory Committee will meet on Dec. 9 to discuss a BLA for…

    Published on 9/28/2015
  • RI-002 regulatory update

    ADMA Biologics Inc. (NASDAQ:ADMA), Ramsey, N.J. Product: RI-002 Business: Autoimmune FDA accepted for review a BLA from ADMA for RI-002 for patients with primary immunodeficiency. The PDUFA date is in 2H16; AMDA …

    Published on 9/28/2015

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