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Chronological Index of : Regulatory

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  • Adapalene 0 regulatory update

    Galderma S.A., Lausanne, Switzerland Maruho Co. Ltd., Osaka, Japan Product: Adapalene 0.1%/benzoyl peroxide 2.5% (Epiduo) Business: Dermatology Galderma said Japan approved Epiduo adapalene/benzoyl peroxide to treat …

    Published on 7/18/2016
  • Adcetris brentuximab vedotin regulatory update

    Seattle Genetics Inc. (NASDAQ:SGEN), Bothell, Wash. Takeda Pharmaceutical Co. Ltd. (Tokyo:4502), Osaka, Japan Product: Adcetris brentuximab vedotin (SGN-35) Business: Cancer The European Commission approved an expanded …

    Published on 7/18/2016
  • Aggrastat tirofiban regulatory update

    Medicure Inc. (TSX-V:MPH), Winnipeg, Manitoba Merck & Co. Inc. (NYSE:MRK), Kenilworth, N.J. Product: Aggrastat tirofiban Business: Cardiovascular FDA issued a complete response letter to Medicure for an sNDA for …

    Published on 7/18/2016
  • Biosimilar adalimumab regulatory update

    Amgen Inc. (NASDAQ:AMGN), Thousand Oaks, Calif. Product: Biosimilar adalimumab (ABP 501) Business: Autoimmune FDAs Arthritis Advisory Committee voted unanimously to recommend approval of a BLA from Amgen for ABP 501, a …

    Published on 7/18/2016
  • Biosimilar etanercept regulatory update

    Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland Product: Biosimilar etanercept (GP2015) Business: Autoimmune FDAs Arthritis Advisory Committee voted unanimously to recommend approval of GP2015, a biosimilar of …

    Published on 7/18/2016
  • Epclusa sofosbuvir/velpatasvir regulatory update

    Gilead Sciences Inc. (NASDAQ:GILD), Foster City, Calif. Product: Epclusa sofosbuvir/velpatasvir (Sofosbuvir/GS-5816) Business: Infectious The European Commission and Health Canada approved Epclusa sofosbuvir/velpatasvir…

    Published on 7/18/2016
  • Exparel bupivacaine regulatory update

    Pacira Pharmaceuticals Inc. (NASDAQ:PCRX), Parsippany, N.J. Product: Exparel bupivacaine (formerly DepoBupivacaine) Business: Neurology FDA posted a notice on its Adverse Event Reporting System (AERS) that the agency is…

    Published on 7/18/2016
  • FluMist Quadrivalent regulatory update

    AstraZeneca plc (LSE:AZN; NYSE:AZN), London, U.K. Product: FluMist Quadrivalent (Fluenz Tetra) (MEDI-3250) Business: Infectious FDA said the benefits of FluMist Quadrivalent from AstraZeneca to prevent seasonal …

    Published on 7/18/2016
  • Lumicef brodalumab regulatory update

    Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151), Tokyo, Japan AstraZeneca plc (LSE:AZN; NYSE:AZN), London, U.K. Product: Lumicef brodalumab (KHK4827) (formerly AMG 827) Business: Autoimmune Japan approved Lumicef brodalumab …

    Published on 7/18/2016
  • OneCrinone regulatory update

    Allergan plc (NYSE:AGN), Dublin, Ireland Juniper Pharmaceuticals Inc. (NASDAQ:JNP), Boston, Mass. Merck KGaA (Xetra:MRK), Darmstadt, Germany Product: OneCrinone (Crinone) progesterone (Prochieve) Business: Endocrine/…

    Published on 7/18/2016
  • Ongentys opicapone regulatory update

    Bial-Portela & Ca. S.A., S. Mamede do Coronado, Portugal Product: Ongentys opicapone (ONO-2370) (formerly BIA 9-1067) Business: Neurology The European Commission approved Ongentys opicapone from Bial-Portela as an …

    Published on 7/18/2016
  • Praluent alirocumab regulatory update

    Regeneron Pharmaceuticals Inc. (NASDAQ:REGN), Tarrytown, N.Y. Sanofi (Euronext:SAN; NYSE:SNY), Paris, France Product: Praluent alirocumab (SAR236553, REGN727) Business: Endocrine/Metabolic The partners said Japan …

    Published on 7/18/2016
  • Repatha evolocumab regulatory update

    Amgen Inc. (NASDAQ:AMGN), Thousand Oaks, Calif. Product: Repatha evolocumab (AMG 145) Business: Endocrine/Metabolic FDA approved the Repatha Pushtronex system to deliver a once-monthly 420 mg subcutaneous dose of Amgens…

    Published on 7/18/2016
  • Syndros dronabinol oral solution regulatory update

    Insys Therapeutics Inc. (NASDAQ:INSY), Phoenix, Ariz. Product: Syndros dronabinol oral solution Business: Gastrointestinal FDA approved an NDA from Insys for Syndros dronabinol oral solution to treat anorexia associated…

    Published on 7/18/2016
  • Vimpat lacosamide regulatory update

    UCB Group (Euronext:UCB), Brussels, Belgium Daiichi Sankyo Co. Ltd. (Tokyo:4568), Tokyo, Japan Product: Vimpat lacosamide Business: Neurology Daiichi and UCB said Japan approved Vimpat lacosamide as an adjunctive …

    Published on 7/18/2016
  • Xiidra lifitegrast regulatory update

    Shire plc (LSE:SHP; NASDAQ:SHPG), Dublin, Ireland Product: Xiidra lifitegrast (SHP606, SAR 1118) Business: Ophthalmic FDA approved an NDA from Shire for Xiidra lifitegrast to treat signs and symptoms of dry eye disease …

    Published on 7/18/2016
  • Xolair omalizumab regulatory update

    Genentech Inc., South San Francisco, Calif. Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland Roche (SIX:ROG; OTCQX:RHHBY), Basel, Switzerland Product: Xolair omalizumab (RG3648) Business: Inflammation FDA approved …

    Published on 7/18/2016
  • Zinbryta daclizumab regulatory update

    Biogen Inc. (NASDAQ:BIIB), Cambridge, Mass. AbbVie Inc. (NYSE:ABBV), Chicago, Ill. Product: Zinbryta daclizumab (DAC HYP) Business: Autoimmune The European Commission approved Zinbryta daclizumab from Biogen to treat …

    Published on 7/18/2016
  • Zydelig idelalisib regulatory update

    Gilead Sciences Inc. (NASDAQ:GILD), Foster City, Calif. Product: Zydelig idelalisib (formerly GS-1101, CAL-101, GS 1101) Business: Cancer EMAs Pharmacovigilance Risk Assessment Committee (PRAC) completed its review of …

    Published on 7/18/2016
  • Adempas riociguat regulatory update

    Bayer AG (Xetra:BAYN), Leverkusen, Germany Merck & Co. Inc. (NYSE:MRK), Kenilworth, N.J. Product: Adempas riociguat (BAY 63-2521) Business: Cardiovascular EMAs CHMP recommended against the use of Adempas riociguat from …

    Published on 7/11/2016
  • Arymo ER morphine sulfate extended-release regulatory update

    Egalet Corp. (NASDAQ:EGLT), Wayne, Pa. Product: Arymo ER morphine sulfate extended-release (formerly Egalet-001) Business: Neurology FDAs Anesthetic and Analgesic Drug Products and Drug Safety and Risk Management …

    Published on 7/11/2016
  • Avycaz regulatory update

    Allergan plc (NYSE:AGN), Dublin, Ireland AstraZeneca plc (LSE:AZN; NYSE:AZN), London, U.K. Product: Avycaz (Zavicefta - EU) ceftazidime/avibactam (CAZ-104) Business: Infectious The European Commission approved Zavicefta…

    Published on 7/11/2016
  • Bempedoic acid regulatory update

    Esperion Therapeutics Inc. (NASDAQ:ESPR), Ann Arbor, Mich. Product: Bempedoic acid (ETC-1002) Business: Endocrine/Metabolic Esperion said FDA did not provide clarity on a regulatory pathway about an LDL-C lowering …

    Published on 7/11/2016
  • Binimetinib regulatory update

    Array BioPharma Inc. (NASDAQ:ARRY), Boulder, Colo. Laboratoires Pierre Fabre S.A., Castres, France Product: Binimetinib (MEK162) (formerly ARRY-162) Business: Cancer Array submitted an NDA to FDA for binimetinib to …

    Published on 7/11/2016
  • Cervarix regulatory update

    GlaxoSmithKline plc (LSE:GSK; NYSE:GSK), London, U.K. Product: Cervarix Business: Infectious EMAs CHMP recommended expanding the label of Cervarix from GlaxoSmithKline to include prevention of premalignant anal lesions …

    Published on 7/11/2016

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