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Chronological Index of : Regulatory

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  • Vycavert hydrocodone bitartrate/acetaminophen regulatory update

    Acura Pharmaceuticals Inc. (NASDAQ:ACUR), Palatine, Ill. Product: Vycavert hydrocodone bitartrate/acetaminophen Business: Neurology Acura said FDA denied on procedural grounds the company's formal dispute resolution …

    Published on 10/27/2014
  • 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New Brunswick, N.J. Product: Xarelto rivaroxaban (BAY 59-7939) Business: Cardiovascular The U.K.'s NICE issued draft guidance recommending use of …

    Published on 10/27/2014
  • Xiaflex regulatory update

    Auxilium Pharmaceuticals Inc. (NASDAQ:AUXL), Chesterbrook, Pa. BioSpecifics Technologies Corp. (NASDAQ:BSTC), Lynbrook, N.Y. Swedish Orphan Biovitrum AB (SSE:SOBI), Stockholm, Sweden Asahi Kasei Pharma Corp., Tokyo, …

    Published on 10/27/2014
  • Xtandi enzalutamide regulatory update

    Medivation Inc. (NASDAQ:MDVN), San Francisco, Calif. Astellas Pharma Inc. (Tokyo:4503), Tokyo, Japan Product: Xtandi enzalutamide (formerly MDV3100) Business: Cancer EMA's CHMP recommended expanding the label of Xtandi …

    Published on 10/27/2014
  • AirFluSal forspiro Salmeterol/fluticasone regulatory update

    Vectura Group plc (LSE:VEC), Chippenham, U.K. Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland Product: AirFluSal forspiro Salmeterol/fluticasone (IrFlosol Forspiro) (formerly VR315) Business: Pulmonary Novartis' …

    Published on 10/20/2014
  • Androxal enclomiphene regulatory update

    Repros Therapeutics Inc. (NASDAQ:RPRX), The Woodlands, Texas Product: Androxal enclomiphene Business: Endocrine/Metabolic Repros said its meeting in early November with FDA to discuss Androxal enclomiphene to treat …

    Published on 10/20/2014
  • Asfotase alfa regulatory update

    Alexion Pharmaceuticals Inc. (NASDAQ:ALXN), Cheshire, Conn. Product: Asfotase alfa (ENB-0040) Business: Endocrine/Metabolic Alexion submitted an NDA to Japan's Ministry of Health, Labor and Welfare (MHLW) for asfotase …

    Published on 10/20/2014
  • Banzel rufinamide regulatory update

    Eisai Co. Ltd. (Tokyo:4523), Tokyo, Japan Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland Product: Banzel rufinamide (Inovelon) (SYN-111) Business: Neurology FDA accepted and granted Priority Review to an sNDA from…

    Published on 10/20/2014
  • Decipher Prostate Cancer Classifier regulatory update

    GenomeDx Biosciences Inc., Vancouver, B.C. Product: Decipher Prostate Cancer Classifier Business: Diagnostic GenomeDx said Medicare administrative contractor Palmetto GBA issued a draft local coverage determination (LCD…

    Published on 10/20/2014
  • Eloctate RFVIIIFc regulatory update

    Biogen Idec Inc. (NASDAQ:BIIB), Weston, Mass. Swedish Orphan Biovitrum AB (SSE:SOBI), Stockholm, Sweden UCB Group (Euronext:UCB), Brussels, Belgium Product: Eloctate RFVIIIFc (Elocta) Business: Hematology Biogen Idec …

    Published on 10/20/2014
  • Embeda morphine/naltrexone regulatory update

    Pfizer Inc. (NYSE:PFE), New York, N.Y. Product: Embeda morphine/naltrexone (ALO-01) Business: Neurology FDA approved an sNDA from Pfizer to update the label of Embeda morphine/naltrexone to include a claim indicating …

    Published on 10/20/2014
  • Glivec imatinib regulatory update

    Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland Product: Glivec imatinib (Gleevec) (QTI571) Business: Cancer The U.K.'s NICE issued a final appraised determination (FAD) recommending 400 mg daily Glivec imatinib …

    Published on 10/20/2014
  • Harvoni ledipasvir regulatory update

    Gilead Sciences Inc. (NASDAQ:GILD), Foster City, Calif. Product: Harvoni ledipasvir (GS-5885)/sofosbuvir (GS-7977) Business: Infectious Gilead submitted an NDA in Japan for ledipasvir/sofosbuvir to treat chronic HCV …

    Published on 10/20/2014
  • Humira adalimumab regulatory update

    AbbVie Inc. (NYSE:ABBV), Chicago, Ill. Eisai Co. Ltd. (Tokyo:4523), Tokyo, Japan Product: Humira adalimumab Business: Autoimmune FDA approved an sBLA from AbbVie for Humira adalimumab to treat moderately to severely …

    Published on 10/20/2014
  • Iclusig ponatinib regulatory update

    Ariad Pharmaceuticals Inc. (NASDAQ:ARIA), Cambridge, Mass. Product: Iclusig ponatinib (formerly AP24534) Business: Cancer EMA's Pharmacovigilance Risk Assessment Committee (PRAC) recommended strengthening the warnings …

    Published on 10/20/2014
  • Imbruvica ibrutinib regulatory update

    Pharmacyclics Inc. (NASDAQ:PCYC), Sunnyvale, Calif. Johnson & Johnson (NYSE:JNJ), New Brunswick, N.J. Product: Imbruvica ibrutinib (PCI-32765) Business: Cancer Johnson & Johnson's Janssen-Cilag International N.V. unit …

    Published on 10/20/2014
  • Imnovid pomalidomide regulatory update

    Celgene Corp. (NASDAQ:CELG), Summit, N.J. Product: Imnovid pomalidomide (Pomalyst) (CC-4047) Business: Cancer The U.K.'s NICE issued a preliminary appraisal recommending against use of Imnovid pomalidomide from Celgene …

    Published on 10/20/2014
  • Jetrea ocriplasmin regulatory update

    ThromboGenics N.V. (Euronext:THR), Leuven, Belgium Product: Jetrea ocriplasmin (formerly Microplasmin) Business: Ophthalmic ThromboGenics said Australia's Therapeutic Goods Administration (TGA) approved Jetrea …

    Published on 10/20/2014
  • Lucentis ranibizumab regulatory update

    Genentech Inc., South San Francisco, Calif. Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland Roche (SIX:ROG; OTCQX:RHHBY), Basel, Switzerland Product: Lucentis ranibizumab (RG3645) Business: Ophthalmic FDA accepted …

    Published on 10/20/2014
  • Lymphoseek tilmanocept regulatory update

    Hainan Sinotau Pharmaceutical Co. Ltd, Beijing, China Navidea Biopharmaceuticals Inc. (NYSE-M:NAVB), Dublin, Ohio Product: Lymphoseek tilmanocept Business: Diagnostic FDA approved an sNDA from Navidea for Lymphoseek …

    Published on 10/20/2014
  • Lyra Adenovirus Assay regulatory update

    Quidel Corp. (NASDAQ:QDEL), San Diego, Calif. Product: Lyra Adenovirus Assay Business: Diagnostic Quidel said FDA granted 510(k) clearance to its Lyra Adenovirus Assay to qualitatively detect human adenovirus viral DNA …

    Published on 10/20/2014
  • Ofev nintedanib regulatory update

    Boehringer Ingelheim GmbH, Ingelheim, Germany Product: Ofev nintedanib (BIBF 1120) Business: Pulmonary FDA approved Ofev nintedanib from Boehringer to treat idiopathic pulmonary fibrosis (IPF). Ofev had a PDUFA date of …

    Published on 10/20/2014
  • 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 Scottish Medicines …

    Published on 10/20/2014
  • Ozurdex dexamethasone intravitreal implant regulatory update

    Allergan Inc. (NYSE:AGN), Irvine, Calif. Product: Ozurdex dexamethasone intravitreal implant (SK-0503) (formerly Posurdex) Business: Ophthalmic FDA approved an sNDA from Allergan for Ozurdex dexamethasone intravitreal …

    Published on 10/20/2014
  • Palbociclib regulatory update

    Amgen Inc. (NASDAQ:AMGN), Thousand Oaks, Calif. Pfizer Inc. (NYSE:PFE), New York, N.Y. Product: Palbociclib (PD-0332991) Business: Cancer FDA accepted and granted Priority Review to an NDA for palbociclib in combination…

    Published on 10/20/2014

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