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Chronological Index of : Regulatory

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  • PLAC Test for Lp-PLA2 Activity regulatory update

    diaDexus Inc. (OTCBB:DDXS), South San Francisco, Calif. Product: PLAC Test for Lp-PLA2 Activity Business: Diagnostic diaDexus said FDA accepted for review a 510(k) submission of the companys PLAC Test for Lp-PLA2 …

    Published on 7/28/2014
  • Plegridy peginterferon beta-1a regulatory update

    Biogen Idec Inc. (NASDAQ:BIIB), Weston, Mass. Product: Plegridy peginterferon beta-1a (BIIB017) Business: Autoimmune Biogen Idec said the European Commission approved Plegridy peginterferon beta-1a to treat relapsing-…

    Published on 7/28/2014
  • RTS regulatory update

    GlaxoSmithKline plc (LSE:GSK; NYSE:GSK), London, U.K. Product: RTS,S vaccine (Mosquirix) (GSK257049) Business: Infectious EMA accepted for review an MAA from GlaxoSmithKline for its RTS,S malaria vaccine moving the …

    Published on 7/28/2014
  • SAGE-547 regulatory update

    Sage Therapeutics Inc. (NASDAQ:SAGE), Cambridge, Mass. Product: SAGE-547 Business: Neurology Sage said FDA granted Fast Track designation to SAGE-547 to treat status epilepticus, a rare disease in which patients …

    Published on 7/28/2014
  • Stivarga regorafenib regulatory update

    Bayer AG (Xetra:BAYN), Leverkusen, Germany Product: Stivarga regorafenib (fluoro-sorafenib) (BAY 73-4506) Business: Cancer EMAs CHMP recommended approval of an MAA from Bayer seeking to expand the label of Stivarga …

    Published on 7/28/2014
  • Targiniq ER oxycodone/naloxone regulatory update

    Mundipharma International Ltd., Cambridge, U.K. Purdue Pharma L.P., Stamford, Conn. Shionogi & Co. Ltd. (Tokyo:4507), Osaka, Japan Product: Targiniq ER oxycodone/naloxone (Targin) Business: Neurology FDA approved an NDA…

    Published on 7/28/2014
  • Vazculep phenylephrine regulatory update

    Flamel Technologies S.A. (NASDAQ:FLML), Lyon, France Product: Vazculep phenylephrine Business: Cardiovascular FDA approved an NDA from Flamel for Vazculep phenylephrine to treat clinically important hypotension …

    Published on 7/28/2014
  • Vimizim elosulfase alfa regulatory update

    BioMarin Pharmaceutical Inc. (NASDAQ:BMRN), Novato, Calif. Product: Vimizim elosulfase alfa (BMN-110) (formerly GALNS) Business: Endocrine/Metabolic BioMarin said Health Canada approved an NDS for Vimizim elosulfase …

    Published on 7/28/2014
  • Zarzio regulatory update

    Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland Product: Zarzio ( Filgrastim Hexal) filgrastim Business: Hematology Novartis Sandoz Inc. generics unit said FDA accepted a BLA for a biosimilar version of neutropenia…

    Published on 7/28/2014
  • Zydelig idelalisib regulatory update

    Gilead Sciences Inc. (NASDAQ:GILD), Foster City, Calif. Product: Zydelig idelalisib (formerly GS-1101, CAL-101, GS 1101) Business: Cancer FDA approved an NDA from Gilead for Zydelig idelalisib for 3 blood cancers while …

    Published on 7/28/2014
  • Amitiza lubiprostone regulatory update

    Sucampo Pharmaceuticals Inc. (NASDAQ:SCMP), Bethesda, Md. Takeda Pharmaceutical Co. Ltd. (Tokyo:4502), Osaka, Japan Product: Amitiza lubiprostone (SPI-0211) Business: Gastrointestinal Sucampo said Swissmedic approved …

    Published on 7/21/2014
  • Blinatumomab regulatory update

    Amgen Inc. (NASDAQ:AMGN), Thousand Oaks, Calif. Astellas Pharma Inc. (Tokyo:4503), Tokyo, Japan Product: Blinatumomab (AMG 103) (formerly MT103) Business: Cancer Amgen said FDA granted breakthrough therapy designation …

    Published on 7/21/2014
  • Brexpiprazole regulatory update

    H. Lundbeck A/S (CSE:LUN), Copenhagen, Denmark Otsuka Pharmaceutical Co. Ltd., Tokyo, Japan Product: Brexpiprazole (OPC-34712) Business: Neurology Lundbeck and Otsuka submitted an NDA to FDA for brexpiprazole to treat …

    Published on 7/21/2014
  • Iluvien fluocinolone acetonide intravitreal implant regulatory update

    Alimera Sciences Inc. (NASDAQ:ALIM), Alpharetta, Ga. pSivida Corp. (NASDAQ:PSDV; ASX:PVA), Watertown, Mass. Specialised Therapeutics Australia Pty. Ltd., Melbourne, Australia Product: Iluvien fluocinolone acetonide …

    Published on 7/21/2014
  • Infliximab regulatory update

    Celltrion Inc. (KOSDAQ:068270), Incheon, South Korea Nippon Kayaku Co. Ltd. (Tokyo:4272), Tokyo, Japan Product: Infliximab (Remsima, Inflectra) (CT-P13) Business: Autoimmune Celltrion said Turkeys Ministry of Health …

    Published on 7/21/2014
  • Isavuconazole regulatory update

    Basilea Pharmaceutica AG (SIX:BSLN), Basel, Switzerland Astellas Pharma Inc. (Tokyo:4503), Tokyo, Japan Product: Isavuconazole (BAL8557) Business: Infectious Basilea submitted an MAA to EMA for isavuconazole to treat …

    Published on 7/21/2014
  • Jakavi ruxolitinib regulatory update

    Incyte Corp. (NASDAQ:INCY), Wilmington, Del. Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland Product: Jakavi ruxolitinib (INCB18424) Business: Hematology Incyte said Japan approved Jakavi ruxolitinib to treat …

    Published on 7/21/2014
  • LCZ696 regulatory update

    Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland Product: LCZ696 Business: Cardiovascular Novartis disclosed in its 2Q14 earnings that FDA granted Fast Track designation to LCZ696 to treat chronic heart failure (CHF…

    Published on 7/21/2014
  • Lisa Tracker Bevacizumab kit regulatory update

    Theradiag (Euronext:ALTER), Marne La Vallee, France Product: Lisa Tracker Bevacizumab kit Business: Diagnostic Theradiag received CE Mark approval in the EU for Lisa Tracker Bevacizumab kit to monitor treatment with …

    Published on 7/21/2014
  • NovoSeven RT regulatory update

    Novo Nordisk A/S (CSE:NVO; NYSE:NVO), Bagsvaerd, Denmark Product: NovoSeven RT Business: Hematology FDA approved Novo Nordisks NovoSeven RT recombinant coagulation Factor VIIa to treat bleeding episodes and for …

    Published on 7/21/2014
  • Olysio simeprevir regulatory update

    Medivir AB (SSE:MVIR B), Huddinge, Sweden Johnson & Johnson (NYSE:JNJ), New Brunswick, N.J. Product: Olysio simeprevir (Sovriad, Galexos) Business: Infectious FDA accepted and granted Priority Review to an sNDA from …

    Published on 7/21/2014
  • Rasuvo methotrexate regulatory update

    Medac GmbH, Wedel, Germany Product: Rasuvo methotrexate (MPI-2505) Business: Autoimmune FDA approved an NDA for Rasuvo methotrexate an autopen containing subcutaneous injectable methotrexate to manage severe, active …

    Published on 7/21/2014
  • Relistor methylnaltrexone regulatory update

    Progenics Pharmaceuticals Inc. (NASDAQ:PGNX), Tarrytown, N.Y. Salix Pharmaceuticals Ltd. (NASDAQ:SLXP), Raleigh, N.C. Ono Pharmaceutical Co. Ltd. (Tokyo:4528), Osaka, Japan Product: Relistor methylnaltrexone (MNTX) (MOA…

    Published on 7/21/2014
  • ReShape Integrated Dual Balloon System regulatory update

    ReShape Medical Inc., San Clemente, Calif. Product: ReShape Integrated Dual Balloon System Business: Endocrine/Metabolic ReShape said it submitted a PMA to FDA for its ReShape Integrated Dual Balloon System for non-…

    Published on 7/21/2014
  • Rextoro regulatory update

    Clarus Therapeutics Inc., Northbrook, Ill. Product: Rextoro (formerly CLR-610) Business: Endocrine/Metabolic FDAs Bone, Reproductive and Urologic Drugs and Drug Safety and Risk Management advisory committees will meet …

    Published on 7/21/2014

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