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Chronological Index of : Regulatory

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  • Illumigene Malaria regulatory update

    Meridian Bioscience Inc. (NASDAQ:VIVO), Cincinnati, Ohio Product: Illumigene Malaria Business: Diagnostic Meridian received CE Mark approval for its illumigene Malaria test to detect malaria. The molecular test uses …

    Published on 2/1/2016
  • IVIG-SN regulatory update

    Green Cross Corp. (KSE:006280), Yongin-si, South Korea Product: IVIG-SN Business: Autoimmune Green Cross said FDA accepted for review a BLA for IVIG-SN to treat primary immunodeficiency diseases (PID). The PDUFA data is…

    Published on 2/1/2016
  • Jardiance empagliflozin regulatory update

    Boehringer Ingelheim GmbH, Ingelheim, Germany Eli Lilly and Co. (NYSE:LLY), Indianapolis, Ind. Product: Jardiance empagliflozin (BI-10773) Business: Endocrine/Metabolic Eli Lilly and Boehringer said FDA accepted for …

    Published on 2/1/2016
  • Lifitegrast regulatory update

    Shire plc (LSE:SHP; NASDAQ:SHPG), Dublin, Ireland Product: Lifitegrast (SHP606, SAR 1118) Business: Ophthalmic Shire resubmitted an NDA to FDA for lifitegrast to treat signs and symptoms of dry eye disease in adults. In…

    Published on 2/1/2016
  • Lynparza olaparib regulatory update

    AstraZeneca plc (LSE:AZN; NYSE:AZN), London, U.K. Product: Lynparza olaparib (AZD2281, KU-0059436) Business: Cancer FDA granted breakthrough therapy designation to Lynparza olaparib from AstraZeneca as monotherapy to …

    Published on 2/1/2016
  • Opdivo nivolumab regulatory update

    Ono Pharmaceutical Co. Ltd. (Tokyo:4528), Osaka, Japan Bristol-Myers Squibb Co. (NYSE:BMY), New York, N.Y. Product: Opdivo nivolumab (ONO-4538, MDX-1106, BMS-936558) Business: Cancer FDA approved an sBLA from Bristol-…

    Published on 2/1/2016
  • Padeliporfin di-potassium regulatory update

    Steba Biotech Ltd., Luxembourg, Luxembourg Product: Padeliporfin di-potassium (Tookad) Business: Cancer Steba submitted an MAA to EMA for Tookad padeliporfin di-potassium to treat localized prostate cancer. The product …

    Published on 2/1/2016
  • Repatha evolocumab regulatory update

    Amgen Inc. (NASDAQ:AMGN), Thousand Oaks, Calif. Astellas Pharma Inc. (Tokyo:4503), Tokyo, Japan Product: Repatha evolocumab (AMG 145) Business: Endocrine/Metabolic Japan approved Repatha evolocumab from Amgen to treat …

    Published on 2/1/2016
  • Venetoclax regulatory update

    Genentech Inc., South San Francisco, Calif. AbbVie Inc. (NYSE:ABBV), Chicago, Ill. Roche (SIX:ROG; OTCQX:RHHBY), Basel, Switzerland Product: Venetoclax (ABT-199, RG7601) (formerly GDC-0199) Business: Cancer AbbVie said …

    Published on 2/1/2016
  • 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 Egalet submitted an NDA to FDA for Arymo ER morphine sulfate extended-release tablets …

    Published on 1/25/2016
  • Arzerra ofatumumab regulatory update

    Genmab A/S (CSE:GEN), Copenhagen, Denmark Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland Product: Arzerra ofatumumab (HuMax-CD20) Business: Cancer FDA approved an sBLA from Novartis for Arzerra ofatumumab for …

    Published on 1/25/2016
  • Baricitinib regulatory update

    Incyte Corp. (NASDAQ:INCY), Wilmington, Del. Eli Lilly and Co. (NYSE:LLY), Indianapolis, Ind. Product: Baricitinib (LY3009104) (formerly INCB28050) Business: Autoimmune Eli Lilly submitted an NDA to FDA for once-daily …

    Published on 1/25/2016
  • Benzhydrocodone/acetaminophen regulatory update

    KemPharm Inc. (NASDAQ:KMPH), Coralville, Iowa Product: Benzhydrocodone/acetaminophen (KP201/APAP) Business: Neurology KemPharm submitted an NDA to FDA and requested Priority Review for KP201/APAP to treat acute pain. …

    Published on 1/25/2016
  • Biosimilar etanercept regulatory update

    Biogen Inc. (NASDAQ:BIIB), Cambridge, Mass. Samsung Group, Seoul, South Korea Product: Biosimilar etanercept (Brenzys, Benepali, SB4) Business: Autoimmune The European Commission approved an MAA from Samsung Bioepis Co.…

    Published on 1/25/2016
  • Biosimilar infliximab regulatory update

    Celltrion Inc. (KOSDAQ:068270), Incheon, South Korea Pfizer Inc. (NYSE:PFE), New York, N.Y. Product: Biosimilar infliximab (Remsima, Inflectra) (CT-P13) Business: Autoimmune FDAs Arthritis Advisory Committee will meet …

    Published on 1/25/2016
  • Briviact brivaracetam regulatory update

    UCB Group (Euronext:UCB), Brussels, Belgium Product: Briviact brivaracetam (formerly Rikelta) Business: Neurology UCB said the European Commission approved Briviact brivaracetam as an adjunct therapy to treat partial-…

    Published on 1/25/2016
  • Epinephrine pre-filled single dose syringe regulatory update

    Adamis Pharmaceuticals Corp. (NASDAQ:ADMP), San Diego, Calif. Product: Epinephrine pre-filled single dose syringe Business: Inflammation FDA accepted for review an NDA for epinephrine pre-filled syringe from Adamis for …

    Published on 1/25/2016
  • Etelcalcetide regulatory update

    Amgen Inc. (NASDAQ:AMGN), Thousand Oaks, Calif. Ono Pharmaceutical Co. Ltd. (Tokyo:4528), Osaka, Japan Product: Etelcalcetide (ONO-5163, AMG 416) (formerly KAI-4169) Business: Endocrine/Metabolic Ono submitted a …

    Published on 1/25/2016
  • Eteplirsen regulatory update

    Sarepta Therapeutics Inc. (NASDAQ:SRPT), Cambridge, Mass. Product: Eteplirsen (AVI-4658) Business: Musculoskeletal FDA postponed a Jan. 22 meeting of its Peripheral and Central Nervous System Drugs Advisory Committee to…

    Published on 1/25/2016
  • EV71 vaccine regulatory update

    Sinovac Biotech Ltd. (NASDAQ:SVA), Beijing, China Product: EV71 vaccine Business: Infectious Sinovac said the China Food and Drug Administration (CFDA) issued a new drug certificate and production license for the …

    Published on 1/25/2016
  • Hiberix regulatory update

    GlaxoSmithKline plc (LSE:GSK; NYSE:GSK), London, U.K. Product: Hiberix Business: Infectious FDA approved an sBLA from GlaxoSmithKline for Hiberix to prevent invasive disease caused by Haemophilus influenza type B (Hib) …

    Published on 1/25/2016
  • Ibudilast regulatory update

    MediciNova Inc. (NASDAQ:MNOV; JASDAQ:4875), San Diego, Calif. Kyorin Pharmaceutical Co. Ltd. (Tokyo:4569), Tokyo, Japan Product: Ibudilast (MN-166, AV411) Business: Neurology MediciNova said FDA granted rare pediatric …

    Published on 1/25/2016
  • Kyndrisa drisapersen regulatory update

    BioMarin Pharmaceutical Inc. (NASDAQ:BMRN), San Rafael, Calif. Product: Kyndrisa drisapersen (PRO051, GSK2402968) Business: Musculoskeletal FDA issued a complete response letter to BioMarin for an NDA for Kyndrisa …

    Published on 1/25/2016
  • Kyprolis carfilzomib regulatory update

    Amgen Inc. (NASDAQ:AMGN), Thousand Oaks, Calif. Product: Kyprolis carfilzomib (PR-171, ONO-7057) Business: Cancer FDA approved an sNDA from Amgen for Kyprolis carfilzomib to treat relapsed or refractory multiple myeloma…

    Published on 1/25/2016
  • Lenvima lenvatinib mesylate regulatory update

    Eisai Co. Ltd. (Tokyo:4523), Tokyo, Japan SFJ Pharmaceuticals Inc., Pleasanton, Calif. Product: Lenvima lenvatinib mesylate (E7080) Business: Cancer Eisai said it submitted an MAA to EMA and that FDA accepted and …

    Published on 1/25/2016

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