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Chronological Index of : Regulatory

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  • NuQ V001 regulatory update

    VolitionRx Ltd. (NYSE-M:VNRX), Singapore Product: NuQ V001 Business: Diagnostic VolitionRx received CE Mark approval for NuQ T003 and NuQ V001 biomarker assays to detect colorectal cancer. The blood-based tests use the …

    Published on 4/25/2016
  • 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 4/25/2016
  • Plecanatide regulatory update

    Synergy Pharmaceuticals Inc. (NASDAQ:SGYP), New York, N.Y. Product: Plecanatide (formerly SP-304) Business: Gastrointestinal FDA accepted for review an NDA from Synergy for plecanatide to treat chronic idiopathic …

    Published on 4/25/2016
  • Ruconest conestat alfa regulatory update

    Pharming Group N.V. (Euronext:PHARM), Leiden, the Netherlands Product: Ruconest conestat alfa (rhC1INH) Business: Inflammation The European Commission approved an expanded label for Ruconest conestat alfa from Pharming …

    Published on 4/25/2016
  • subcutaneous Binocrit epoetin alfa regulatory update

    Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland Product: subcutaneous Binocrit epoetin alfa Business: Hematology The European Commission approved subcutaneous Binocrit epoetin alfa from Novartis Sandoz division to …

    Published on 4/25/2016
  • Vyvanse lisdexamfetamine dimesylate chewable tablets regulatory update

    Shire plc (LSE:SHP; NASDAQ:SHPG), Dublin, Ireland Product: Vyvanse lisdexamfetamine dimesylate chewable tablets Business: Neurology Shire submitted an NDA to FDA for Vyvanse lisdexamfetamine dimesylate chewable tablets …

    Published on 4/25/2016
  • Xtandi enzalutamide regulatory update

    Medivation Inc. (NASDAQ:MDVN), San Francisco, Calif. Astellas Pharma Inc. (Tokyo:4503), Tokyo, Japan Product: Xtandi enzalutamide (formerly MDV3100) Business: Cancer Medivation and Astellas said EMAs CHMP recommended …

    Published on 4/25/2016
  • Atezolizumab regulatory update

    Genentech Inc., South San Francisco, Calif. Roche (SIX:ROG; OTCQX:RHHBY), Basel, Switzerland Product: Atezolizumab (Anti-PDL1) (MPDL3280A, RG7446) Business: Cancer FDA accepted and granted Priority Review to a BLA from …

    Published on 4/18/2016
  • Giotrif afatinib regulatory update

    Boehringer Ingelheim GmbH, Ingelheim, Germany Product: Giotrif afatinib (Tomtovok) (BIBW 2992) Business: Cancer The European Commission approved Giotrif afatinib from Boehringer to treat advanced squamous cell carcinoma…

    Published on 4/18/2016
  • House dust mite regulatory update

    ALK-Abello A/S (CSE:ALK-B), Horsholm, Denmark Merck & Co. Inc. (NYSE:MRK), Kenilworth, N.J. Product: House dust mite (HDM) sublingual allergy immunotherapy (SLIT) (Miticure, Acarizax) (MK-8237, TO-203) Business: …

    Published on 4/18/2016
  • Luveris lutropin alpha regulatory update

    Merck KGaA (Xetra:MRK), Darmstadt, Germany Product: Luveris lutropin alpha Business: Endocrine/Metabolic FDA withdrew approval of an NDA for Mercks infertility drug Luveris lutropin alpha. Merck said it requested the …

    Published on 4/18/2016
  • Marizev omarigliptin regulatory update

    Merck & Co. Inc. (NYSE:MRK), Kenilworth, N.J. Product: Marizev omarigliptin (MK-3102) Business: Endocrine/Metabolic Merck said it will not submit an NDA to FDA or an MAA to EMA for diabetes candidate Marizev …

    Published on 4/18/2016
  • Once-daily glatiramer acetate regulatory update

    Synthon B.V., Nijmegen, the Netherlands Product: Once-daily glatiramer acetate Business: Autoimmune Synthon said it received European approval of its generic once-daily glatiramer acetate, a generic version of once-…

    Published on 4/18/2016
  • OncoBEAM RAS CRC assay regulatory update

    Sysmex Corp. (Tokyo:6869), Kobe, Japan Merck & Co. Inc. (NYSE:MRK), Kenilworth, N.J. Product: OncoBEAM RAS CRC assay Business: Diagnostic Merck and Sysmex said the OncoBEAM RAS CRC assay received CE Mark approval to …

    Published on 4/18/2016
  • Remoxy oxycodone regulatory update

    Durect Corp. (NASDAQ:DRRX), Cupertino, Calif. Pain Therapeutics Inc. (NASDAQ:PTIE), Austin, Texas Product: Remoxy oxycodone (PF-00345439) Business: Neurology Durect and Pain said FDA accepted a resubmitted NDA from Pain…

    Published on 4/18/2016
  • Revolade eltrombopag regulatory update

    Ligand Pharmaceuticals Inc. (NASDAQ:LGND), La Jolla, Calif. Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland Product: Revolade eltrombopag (Promacta) Business: Hematology The European Commission approved Revolade …

    Published on 4/18/2016
  • Rociletinib regulatory update

    Celgene Corp. (NASDAQ:CELG), Summit, N.J. Clovis Oncology Inc. (NASDAQ:CLVS), Boulder, Colo. Product: Rociletinib (AVL-301, CO-1686) Business: Cancer FDAs Oncologic Drugs Advisory Committee (ODAC) voted 12-1 that FDA …

    Published on 4/18/2016
  • Venclexta venetoclax regulatory update

    Genentech Inc., South San Francisco, Calif. AbbVie Inc. (NYSE:ABBV), Chicago, Ill. Roche (SIX:ROG; OTCQX:RHHBY), Basel, Switzerland Product: Venclexta venetoclax (ABT-199, RG7601) (formerly GDC-0199) Business: Cancer …

    Published on 4/18/2016
  • Abaloparatide-SC regulatory update

    Ipsen Group (Euronext:IPN), Boulogne-Billancourt, France Radius Health Inc. (NASDAQ:RDUS), Cambridge, Mass. Teijin Pharma Ltd., Tokyo, Japan Product: Abaloparatide-SC (BA058-SC, ITM-058) (formerly BA058 Injection) …

    Published on 4/11/2016
  • Adynovi regulatory update

    Baxalta Inc. (NYSE:BXLT), Deerfield, Ill. Nektar Therapeutics (NASDAQ:NKTR), San Francisco, Calif. Product: Adynovi, Adynovate (BAX 855) Business: Hematology Baxalta said Japan approved Adynovate to treat hemophilia A …

    Published on 4/11/2016
  • Darzalex daratumumab regulatory update

    Genmab A/S (CSE:GEN), Copenhagen, Denmark Johnson & Johnson (NYSE:JNJ), New Brunswick, N.J. Product: Darzalex daratumumab (HuMax-CD38) Business: Cancer EMAs CHMP recommended conditional approval of Darzalex daratumumab …

    Published on 4/11/2016
  • Descovy emtricitabine/tenofovir alafenamide regulatory update

    Gilead Sciences Inc. (NASDAQ:GILD), Foster City, Calif. Product: Descovy emtricitabine/tenofovir alafenamide (F/TAF) Business: Infectious FDA approved Descovy emtricitabine/tenofovir alafenamide from Gilead to treat HIV…

    Published on 4/11/2016
  • Enstilar calcipotriene/betamethasone dipropionate aerosol foam regulatory update

    Leo Pharma A/S, Ballerup, Denmark Product: Enstilar calcipotriene/betamethasone dipropionate aerosol foam (LEO 90100) Business: Autoimmune Leo said Enstilar calcipotriene/betamethasone received a positive outcome under …

    Published on 4/11/2016
  • Flixabi biosimilar infliximab regulatory update

    Biogen Inc. (NASDAQ:BIIB), Cambridge, Mass. Merck & Co. Inc. (NYSE:MRK), Kenilworth, N.J. Samsung Group, Seoul, South Korea Product: Flixabi biosimilar infliximab (Renflexis) (SB2) Business: Autoimmune EMAs CHMP …

    Published on 4/11/2016
  • Galafold migalastat regulatory update

    Amicus Therapeutics Inc. (NASDAQ:FOLD), Cranbury, N.J. Product: Galafold migalastat (AT1001) (formerly Amigal) Business: Endocrine/Metabolic EMAs CHMP recommended approval of Galafold migalastat from Amicus as a long-…

    Published on 4/11/2016

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