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Chronological Index of : Regulatory

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  • Allplex Respiratory Panel 5 assay regulatory update

    Seegene Inc. (KOSDAQ:096530), Seoul, South Korea Product: Allplex Respiratory Panel 5 assay Business: Diagnostic Seegene said Health Canada approved Allplex Respiratory Panel 5 assay to identify influenza virus A and B,…

    Published on 4/13/2015
  • Androxal enclomiphene regulatory update

    Repros Therapeutics Inc. (NASDAQ:RPRX), The Woodlands, Texas Product: Androxal enclomiphene Business: Endocrine/Metabolic FDA accepted for review an NDA for Androxal enclomiphene from Repros to treat secondary …

    Published on 4/13/2015
  • 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 The European …

    Published on 4/13/2015
  • AXS-02 regulatory update

    Axsome Therapeutics Inc., New York, N.Y. Product: AXS-02 Business: Neurology FDA granted Fast Track designation to Axsomes AXS-02 to treat complex regional pain syndrome (CRPS). The oral, non-opioid candidate is in …

    Published on 4/13/2015
  • Catena idebenone regulatory update

    Santhera Pharmaceuticals Holding AG (SIX:SANN), Liestal, Switzerland Product: Catena idebenone (Sovrima - EU, Raxone - EU) (SNT-MC17) Business: Musculoskeletal FDA granted Fast Track designation to Catena idebenone from…

    Published on 4/13/2015
  • CLT-28643 regulatory update

    Clanotech AB, Solna, Sweden Product: CLT-28643 Business: Ophthalmic FDA granted Orphan Drug designation to CLT-28643 from Clanotech to prevent scarring following glaucoma surgery. The integrin alpha(5)beta(1) antagonist…

    Published on 4/13/2015
  • Contrave naltrexone SR/bupropion SR regulatory update

    Orexigen Therapeutics Inc. (NASDAQ:OREX), La Jolla, Calif. Product: Contrave naltrexone SR/bupropion SR (Mysimba - EU) (NB32) Business: Endocrine/Metabolic The European Commission approved Mysimba naltrexone/buproprion …

    Published on 4/13/2015
  • CRS-207 regulatory update

    Aduro Biotech Inc., Berkeley, Calif. Product: CRS-207 Business: Cancer FDA granted Orphan Drug designation to Aduros CRS-207 to treat mesothelioma. The live attenuated strain of Listeria monocytogenes that expresses …

    Published on 4/13/2015
  • Evarrest Fibrin Sealant Patch regulatory update

    Johnson & Johnson (NYSE:JNJ), New Brunswick, N.J. Product: Evarrest Fibrin Sealant Patch ( Evarrest Sealant Matrix - EU) (Fibrin Pad) (formerly Fibrin Patch) Business: Hematology FDA approved an sBLA from Johnson & …

    Published on 4/13/2015
  • EZN-2279 regulatory update

    Sigma-Tau Group, Pomezia, Italy Teijin Pharma Ltd., Tokyo, Japan Product: EZN-2279 Business: Endocrine/Metabolic FDA granted Orphan Drug designation to EZN-2279 from Sigma-Tau to treat adenosine deaminase deficiency in …

    Published on 4/13/2015
  • Grazoprevir/elbasvir regulatory update

    Merck & Co. Inc. (NYSE:MRK), Whitehouse Station, N.J. Product: Grazoprevir/elbasvir (MK-5172/MK-8742) Business: Infectious Merck said FDA granted breakthrough therapy designations to grazoprevir/elbasvir to treat …

    Published on 4/13/2015
  • Humira adalimumab regulatory update

    AbbVie Inc. (NYSE:ABBV), Chicago, Ill. Eisai Co. Ltd. (Tokyo:4523), Tokyo, Japan Product: Humira adalimumab Business: Autoimmune The European Commission approved an expanded label for Humira adalimumab from AbbVie to …

    Published on 4/13/2015
  • Illumigene Chlamydia regulatory update

    Meridian Bioscience Inc. (NASDAQ:VIVO), Cincinnati, Ohio Product: Illumigene Chlamydia Business: Diagnostic Meridian Bioscience received CE Mark approval for its illumigene Chlamydia test to detect Chlamydia trachomatis…

    Published on 4/13/2015
  • Illumigene Gonorrhea regulatory update

    Meridian Bioscience Inc. (NASDAQ:VIVO), Cincinnati, Ohio Product: Illumigene Gonorrhea Business: Diagnostic Meridian Bioscience received CE Mark approval for its illumigene Chlamydia test to detect Chlamydia trachomatis…

    Published on 4/13/2015
  • IMO-8400 regulatory update

    Idera Pharmaceuticals Inc. (NASDAQ:IDRA), Cambridge, Mass. Product: IMO-8400 Business: Cancer FDA granted Orphan Drug designation to IMO-8400 from Idera to treat diffuse large B cell lymphoma (DLBCL). The toll-like …

    Published on 4/13/2015
  • IRay Radiotherapy system regulatory update

    Oraya Therapeutics Inc., Newark, Calif. Product: IRay Radiotherapy system Business: Cancer Oraya received CE Mark approval for the IRay Radiotherapy system to treat choroidal metastases. The IRay system, which has CE …

    Published on 4/13/2015
  • Jadenu deferasirox regulatory update

    Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland Product: Jadenu deferasirox Business: Hematology FDA approved Jadenu deferasirox from Novartis to treat chronic iron overload in patients ages >=10 with non-…

    Published on 4/13/2015
  • Kengrexal cangrelor regulatory update

    The Medicines Co. (NASDAQ:MDCO), Parsippany, N.J. AstraZeneca plc (LSE:AZN; NYSE:AZN), London, U.K. Product: Kengrexal cangrelor (formerly AR-C69931MX) Business: Cardiovascular The European Commission approved Kengrexal…

    Published on 4/13/2015
  • Kyprolis carfilzomib regulatory update

    Amgen Inc. (NASDAQ:AMGN), Thousand Oaks, Calif. Ono Pharmaceutical Co. Ltd. (Tokyo:4528), Osaka, Japan Product: Kyprolis carfilzomib (PR-171, ONO-7057) Business: Cancer FDA accepted and granted Priority Review to an …

    Published on 4/13/2015
  • Lifitegrast regulatory update

    Shire plc (LSE:SHP; NASDAQ:SHPG), Dublin, Ireland Product: Lifitegrast (SHP606, SAR 1118) Business: Ophthalmic FDA accepted and granted Priority Review to an NDA from Shire for lifitegrast to treat signs and symptoms of…

    Published on 4/13/2015
  • Lisa Tracker kits for ustekinumab regulatory update

    Theradiag (Euronext:ALTER), Marne La Vallee, France Product: Lisa Tracker kits for ustekinumab Business: Diagnostic Theradiag received CE Mark approval for its Lisa Tracker kits to monitor treatment with autoimmune drug…

    Published on 4/13/2015
  • Mucogard regulatory update

    Norgine B.V., Amsterdam, the Netherlands PlasmaTech Biopharmaceuticals Inc. (NASDAQ:PTBI), Dallas, Texas Product: Mucogard (MuGard) Business: Other PlasmaTech said Korea approved a regulatory application from partner …

    Published on 4/13/2015
  • NextSeq CN500 regulatory update

    Berry Genomics Co. Ltd., Beijing, China Illumina Inc. (NASDAQ:ILMN), San Diego, Calif. Product: NextSeq CN500 Business: Diagnostic The Chinese Food and Drug Administration (CFDA) granted premarket clearance to NextSeq …

    Published on 4/13/2015
  • NovoTTF-100A System regulatory update

    Novocure Ltd., Isle of Jersey Product: NovoTTF-100A System (Optune) Business: Cancer Japan approved Optune tumor treating fields (TTFields) delivery device from Novocure to treat recurrent glioblastoma multiforme (GBM).…

    Published on 4/13/2015
  • Orbactiv oritavancin regulatory update

    The Medicines Co. (NASDAQ:MDCO), Parsippany, N.J. Product: Orbactiv oritavancin (formerly LY333328) Business: Infectious The European Commission approved IV Orbactiv oritavancin from The Medicines Co. to treat acute …

    Published on 4/13/2015

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