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Chronological Index of : Regulatory

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  • 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
  • Rhucin regulatory update

    Pharming Group N.V. (Euronext:PHARM), Leiden, the Netherlands Product: Rhucin ( Ruconest - EU) conestat alfa (rhC1INH, Rhucin)) Business: Inflammation FDA approved a resubmitted BLA for Ruconest conestat alfa from …

    Published on 7/21/2014
  • Rienso regulatory update

    3SBio Inc., Shenyang, China AMAG Pharmaceuticals Inc. (NASDAQ:AMAG), Lexington, Mass. Takeda Pharmaceutical Co. Ltd. (Tokyo:4502), Osaka, Japan Product: Rienso ( Feraheme) ferumoxytol Business: Hematology AMAG disclosed…

    Published on 7/21/2014
  • SMT19969 regulatory update

    Summit Corp. plc (LSE:SUMM), Abingdon, U.K. Product: SMT19969, SMT 19969 Business: Infectious Summit said FDA granted Qualified Infectious Disease Product (QIDP) designation to SMT19969 to treat Clostridium difficile …

    Published on 7/21/2014
  • Translarna ataluren regulatory update

    PTC Therapeutics Inc. (NASDAQ:PTCT), South Plainfield, N.J. Product: Translarna ataluren (formerly PTC124) Business: Musculoskeletal PTC said the French National Agency for Medicines and Health Products Safety (ANSM) …

    Published on 7/21/2014
  • Xpansion Interpreter regulatory update

    Asuragen Inc., Austin, Texas Product: Xpansion Interpreter Business: Neurology Asuragen said the New York State Department of Health issued a clinical laboratory permit for its Xpansion Interpreter and miRInform Thyroid…

    Published on 7/21/2014
  • Yervoy ipilimumab regulatory update

    Bristol-Myers Squibb Co. (NYSE:BMY), New York, N.Y. Product: Yervoy ipilimumab (BMS-734016) Business: Cancer Germanys Institute for Quality and Efficiency in Healthcare (IQWiG) said Yervoy ipilimumab from Bristol-Myers …

    Published on 7/21/2014
  • Adempas riociguat regulatory update

    Bayer AG (Xetra:BAYN), Leverkusen, Germany Product: Adempas riociguat (BAY 63-2521) Business: Cardiovascular Bayer said Japan's Ministry of Health, Labor and Welfare (MHLW) approved Adempas riociguat to treat inoperable…

    Published on 1/20/2014
  • Suglat ipragliflozin regulatory update

    Astellas Pharma Inc. (Tokyo:4503), Tokyo, Japan Kotobuki Pharmaceutical Co., Tokyo, Japan Product: Suglat ipragliflozin (ASP1941) Business: Endocrine/Metabolic Astellas said Japan's Ministry of Health, Labor and Welfare…

    Published on 1/20/2014
  • Vascepa icosapent ethyl regulatory update

    Amarin Corp. plc (NASDAQ:AMRN), Dublin, Ireland Product: Vascepa icosapent ethyl (formerly Miraxion, AMR101) Business: Endocrine/Metabolic Amarin said FDA notified the company that the agency will not make a decision on…

    Published on 1/20/2014
  • Xarelto rivaroxaban regulatory update

    Bayer AG (Xetra:BAYN), Leverkusen, Germany Johnson & Johnson (NYSE:JNJ), New Brunswick, N.J. Product: Xarelto rivaroxaban (BAY 59-7939) Business: Cardiovascular FDA's Cardiovascular and Renal Drugs Advisory Committee …

    Published on 1/20/2014

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