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Chronological Index of : Regulatory

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  • Asfotase alfa regulatory update

    Alexion Pharmaceuticals Inc. (NASDAQ:ALXN), Cheshire, Conn. Product: Asfotase alfa (ENB-0040) Business: Endocrine/Metabolic Alexion said Japan's Ministry of Health, Labor and Welfare (MHLW) granted Orphan Drug …

    Published on 9/22/2014
  • DCVax-L regulatory update

    Northwest Biotherapeutics Inc. (NASDAQ:NWBO), Bethesda, Md. Product: DCVax-L (DCVax-Brain) Business: Cancer The U.K.'s Department of Health granted DCVax-L from Northwest Biotherapeutics promising innovative medicine (…

    Published on 9/22/2014
  • Debio 1450 regulatory update

    Debiopharm Group, Lausanne, Switzerland Product: Debio 1450 (formerly AFN-1720) Business: Infectious Debiopharm said FDA granted Qualified Infectious Disease Product (QIDP) designation to Debio 1450 to treat acute …

    Published on 9/22/2014
  • Eylea aflibercept ophthalmic solution regulatory update

    Regeneron Pharmaceuticals Inc. (NASDAQ:REGN), Tarrytown, N.Y. Bayer AG (Xetra:BAYN), Leverkusen, Germany Product: Eylea aflibercept ophthalmic solution (VEGF Trap-Eye) Business: Ophthalmic FDA granted breakthrough …

    Published on 9/22/2014
  • HyQvia Ig infusion 10% regulatory update

    Halozyme Therapeutics Inc. (NASDAQ:HALO), San Diego, Calif. Baxter International Inc. (NYSE:BAX), Deerfield, Ill. Product: HyQvia Ig infusion 10% Business: Hematology FDA approved a BLA from Baxter for subcutaneous …

    Published on 9/22/2014
  • Infimab infliximab regulatory update

    Epirus Biopharmaceuticals Inc. (NASDAQ:EPRS), Boston, Mass. Product: Infimab infliximab (BOW015) Business: Autoimmune The Drug Controller General of India (DCGI) approved manufacturing and marketing of autoimmune …

    Published on 9/22/2014
  • Leuplin leuprorelin acetate regulatory update

    Takeda Pharmaceutical Co. Ltd. (Tokyo:4502), Osaka, Japan Product: Leuplin leuprorelin acetate (Lupron Depot, Enantone) (TAP-144-SR) Business: Cancer Takeda submitted an NDA to Japan's Ministry of Health, Labor and …

    Published on 9/22/2014
  • Liraglutide 3 mg regulatory update

    Novo Nordisk A/S (CSE:NVO; NYSE:NVO), Bagsvaerd, Denmark Product: Liraglutide 3 mg (Saxenda) (NN8022) Business: Endocrine/Metabolic FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 14-1 to recommend …

    Published on 9/22/2014
  • Lymphoseek tilmanocept regulatory update

    Hainan Sinotau Pharmaceutical Co. Ltd, Hainan, China Navidea Biopharmaceuticals Inc. (NYSE-M:NAVB), Dublin, Ohio Product: Lymphoseek tilmanocept Business: Diagnostic Navidea said FDA granted Orphan Drug status for …

    Published on 9/22/2014
  • Movantik naloxegol regulatory update

    Nektar Therapeutics (NASDAQ:NKTR), San Francisco, Calif. AstraZeneca plc (LSE:AZN; NYSE:AZN), London, U.K. Product: Movantik naloxegol (formerly NKTR-118) Business: Gastrointestinal FDA approved an NDA from AstraZeneca …

    Published on 9/22/2014
  • Olysio simeprevir regulatory update

    Medivir AB (SSE:MVIR B), Huddinge, Sweden Johnson & Johnson (NYSE:JNJ), New Brunswick, N.J. Product: Olysio simeprevir (Sovriad, Galexos) (TMC435) (formerly TMC435350) Business: Infectious The U.K.'s NICE issued a …

    Published on 9/22/2014
  • PF-06425090 regulatory update

    Pfizer Inc. (NYSE:PFE), New York, N.Y. Product: PF-06425090 Business: Infectious FDA granted Fast Track designation to Pfizer's PF-06425090 to prevent Clostridium difficile-associated disease. The undisclosed vaccine …

    Published on 9/22/2014
  • Pulmaquin liposomal ciprofloxacin ciprofloxacin regulatory update

    Aradigm Corp. (NASDAQ:ARDM), Hayward, Calif. Grifols S.A. (Madrid:GRF; NASDAQ:GRFS), Barcelona, Spain Product: Pulmaquin liposomal ciprofloxacin ciprofloxacin (ARD-3150) Business: Pulmonary FDA granted Fast Track …

    Published on 9/22/2014
  • Rextoro regulatory update

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

    Published on 9/22/2014
  • Rixubis regulatory update

    Baxter International Inc. (NYSE:BAX), Deerfield, Ill. Product: Rixubis (BAX 326) Business: Hematology FDA approved an sBLA from Baxter for Rixubis to control and prevent bleeding episodes, for perioperative management …

    Published on 9/22/2014
  • Rytary regulatory update

    Impax Laboratories Inc. (NASDAQ:IPXL), Hayward, Calif. Product: Rytary (Patrome) (GSK587124, IPX066) Business: Neurology Impax said FDA extended the PDUFA date by 3 months to Jan. 9, 2015, for a resubmitted NDA for …

    Published on 9/22/2014
  • Savaysa edoxaban regulatory update

    Daiichi Sankyo Co. Ltd. (Tokyo:4568), Tokyo, Japan Product: Savaysa edoxaban (Lixiana) (DU-176b) Business: Cardiovascular FDA's Cardiovascular and Renal Drugs advisory committee will meet on Oct. 30 to discuss an NDA …

    Published on 9/22/2014
  • Stendra avanafil regulatory update

    Vivus Inc. (NASDAQ:VVUS), Mountain View, Calif. Mitsubishi Tanabe Pharma Corp. (Tokyo:4508), Osaka, Japan Sanofi (Euronext:SAN; NYSE:SNY), Paris, France Product: Stendra avanafil (Spedra, Zepeed) Business: Genitourinary…

    Published on 9/22/2014
  • SYN-005 regulatory update

    Intrexon Corp. (NYSE:XON), Germantown, Md. Synthetic Biologics Inc. (NYSE-M:SYN), Rockville, Md. Product: SYN-005 Business: Infectious Synthetic Biologics said FDA granted Orphan Drug designation to SYN-005 to treat …

    Published on 9/22/2014
  • Tafinlar dabrafenib regulatory update

    GlaxoSmithKline plc (LSE:GSK; NYSE:GSK), London, U.K. Product: Tafinlar dabrafenib (GSK2118436) Business: Cancer The U.K.'s NICE issued a final appraisal determination (FAD) recommending Tafinlar dabrafenib from …

    Published on 9/22/2014
  • Tecfidera dimethyl fumarate regulatory update

    Biogen Idec Inc. (NASDAQ:BIIB), Weston, Mass. Product: Tecfidera dimethyl fumarate (formerly BG-12) Business: Autoimmune The U.K.'s NICE published final guidance recommending Tecfidera dimethyl fumarate from Biogen Idec…

    Published on 9/22/2014
  • Thrice-weekly glatiramer regulatory update

    Momenta Pharmaceuticals Inc. (NASDAQ:MNTA), Cambridge, Mass. Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland Product: Thrice-weekly glatiramer Business: Autoimmune Momenta said FDA accepted for review an ANDA for a…

    Published on 9/22/2014
  • Trulicity dulaglutide regulatory update

    Eli Lilly and Co. (NYSE:LLY), Indianapolis, Ind. Product: Trulicity dulaglutide (GLP-1Fc) (LY2189265) Business: Endocrine/Metabolic FDA approved a BLA for Trulicity dulaglutide from Eli Lilly as an adjunct to diet and …

    Published on 9/22/2014
  • Vascepa icosapent ethyl regulatory update

    Amarin Corp. plc (NASDAQ:AMRN), Dublin, Ireland Product: Vascepa icosapent ethyl (formerly AMR101, Miraxion) Business: Endocrine/Metabolic Amarin said FDA's Office of New Drugs denied Amarin's appeal of FDA's rescission…

    Published on 9/22/2014
  • VT-1129 regulatory update

    Viamet Pharmaceuticals Inc., Durham, N.C. Product: VT-1129 Business: Infectious Viamet said FDA granted Orphan Drug designation to VT-1129 to treat cryptococcal meningitis. The company plans to submit an IND to FDA for …

    Published on 9/22/2014

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