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Chronological Index of : Regulatory

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  • Sovaldi sofosbuvir regulatory update

    Gilead Sciences Inc. (NASDAQ:GILD), Foster City, Calif. Product: Sovaldi sofosbuvir (Sovaldi) (GS-7977) (formerly PSI-7977) Business: Infectious The U.K.s NICE issued draft guidance recommending Sovaldi sofosbuvir from …

    Published on 8/18/2014
  • Spiriva Respimat tiotropium regulatory update

    Boehringer Ingelheim GmbH, Ingelheim, Germany Product: Spiriva Respimat tiotropium Business: Pulmonary FDAs Pulmonary-Allergy Drugs Advisory Committee voted 10-3 that existing data support approval of Spiriva Respimat …

    Published on 8/18/2014
  • Stool DNA colorectal cancer screening assay regulatory update

    Exact Sciences Corp. (NASDAQ:EXAS), Madison, Wis. Product: Stool DNA colorectal cancer screening assay (Cologuard) Business: Diagnostic FDA approved a PMA from Exact Sciences for Cologuard as a non-invasive DNA …

    Published on 8/18/2014
  • Tarceva erlotinib regulatory update

    Genentech Inc., South San Francisco, Calif. Astellas Pharma Inc. (Tokyo:4503), Tokyo, Japan Chugai Pharmaceutical Co. Ltd. (Tokyo:4519), Tokyo, Japan Roche (SIX:ROG; OTCQX:RHHBY), Basel, Switzerland Product: Tarceva …

    Published on 8/18/2014
  • Toujeo insulin glargine regulatory update

    Sanofi (Euronext:SAN; NYSE:SNY), Paris, France Product: Toujeo insulin glargine (formerly U300) Business: Endocrine/Metabolic Sanofi disclosed in its 2Q14 earnings that it submitted an NDA last month to Japans …

    Published on 8/18/2014
  • Velcade bortezomib regulatory update

    Takeda Pharmaceutical Co. Ltd. (Tokyo:4502), Osaka, Japan Johnson & Johnson (NYSE:JNJ), New Brunswick, N.J. Product: Velcade bortezomib Business: Cancer Takeda and its Millennium Pharmaceuticals Inc. subsidiary said FDA…

    Published on 8/18/2014
  • 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 The U.K.s NICE issued final guidance recommending …

    Published on 8/18/2014
  • Yervoy ipilimumab regulatory update

    Ono Pharmaceutical Co. Ltd. (Tokyo:4528), Osaka, Japan Bristol-Myers Squibb Co. (NYSE:BMY), New York, N.Y. Product: Yervoy ipilimumab (BMS-734016) Business: Cancer The U.K.s NICE published final guidance recommending …

    Published on 8/18/2014
  • ABT-414 regulatory update

    AbbVie Inc. (NYSE:ABBV), Chicago, Ill. Product: ABT-414 Business: Cancer AbbVie said that FDA and EMA granted Orphan Drug designation to ABT-414 to treat glioblastoma multiforme (GBM). Earlier this year, AbbVie reported…

    Published on 8/11/2014
  • Acticlate doxycycline hyclate regulatory update

    Almirall S.A. (Madrid:ALM), Barcelona, Spain Product: Acticlate doxycycline hyclate Business: Dermatology Almiralls Aqua Pharmaceuticals LLC unit said FDA approved an NDA for Acticlate doxycycline hyclate to treat …

    Published on 8/11/2014
  • AmpliVue GAS Assay regulatory update

    Quidel Corp. (NASDAQ:QDEL), San Diego, Calif. Product: AmpliVue GAS Assay Business: Diagnostic FDA granted 510(k) clearance to Quidels AmpliVue GAS Assay to qualitatively detect Group A beta-hemolytic Streptococcus …

    Published on 8/11/2014
  • Anthrax immune globulin IV regulatory update

    Emergent BioSolutions Inc. (NYSE:EBS), Rockville, Md. Product: Anthrax immune globulin IV (AIGIV), Anthrivig Business: Infectious Emergent submitted a BLA to FDA for Anthrax immune globulin IV (AIGIV) to treat inhaled …

    Published on 8/11/2014
  • Arikace amikacin regulatory update

    Insmed Inc. (NASDAQ:INSM), Monmouth Junction, N.J. Product: Arikace amikacin (Arikayce) (formerly SLIT amikacin) Business: Infectious Insmed said it would need to conduct an additional Phase III trial of Arikayce …

    Published on 8/11/2014
  • Dalvance dalbavancin regulatory update

    Durata Therapeutics Inc. (NASDAQ:DRTX), Chicago, Ill. Gruppo Angelini, Rome, Italy Product: Dalvance dalbavancin (RQ-00000002) Business: Infectious In a final rule, the Centers for Medicare and Medicaid Services (CMS) …

    Published on 8/11/2014
  • Embeda morphine/naltrexone regulatory update

    Pfizer Inc. (NYSE:PFE), New York, N.Y. Product: Embeda morphine/naltrexone (ALO-01) Business: Neurology Pfizer disclosed in its 2Q14 earnings that FDA delayed by 3 months the PDUFA date for an sNDA seeking to expand the…

    Published on 8/11/2014
  • Eraxis regulatory update

    RaQualia Pharma Inc. (JASDAQ:4579), Nagoya, Japan Pfizer Inc. (NYSE:PFE), New York, N.Y. Product: Eraxis ( Ecalta - EU) anidulafungin Business: Infectious EMAs CHMP issued a positive opinion recommending varying the …

    Published on 8/11/2014
  • Gazyva regulatory update

    Biogen Idec Inc. (NASDAQ:BIIB), Weston, Mass. Genentech Inc., South San Francisco, Calif. Chugai Pharmaceutical Co. Ltd. (Tokyo:4519), Tokyo, Japan Nippon Shinyaku Co. Ltd. (Tokyo:4516), Kyoto, Japan Roche (SIX:ROG; …

    Published on 8/11/2014
  • Iluvien fluocinolone acetonide intravitreal implant regulatory update

    Alimera Sciences Inc. (NASDAQ:ALIM), Alpharetta, Ga. pSivida Corp. (NASDAQ:PSDV; ASX:PVA), Watertown, Mass. Specialised Therapeutics Australia Pty. Ltd., Melbourne, Australia Product: Iluvien fluocinolone acetonide …

    Published on 8/11/2014
  • Jakafi regulatory update

    Incyte Corp. (NASDAQ:INCY), Wilmington, Del. Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland Product: Jakafi ( Jakavi) ruxolitinib (INCB18424) Business: Hematology FDA accepted and granted Priority Review to an …

    Published on 8/11/2014
  • Kadcyla trastuzumab emtansine regulatory update

    Genentech Inc., South San Francisco, Calif. ImmunoGen Inc. (NASDAQ:IMGN), Waltham, Mass. Chugai Pharmaceutical Co. Ltd. (Tokyo:4519), Tokyo, Japan Roche (SIX:ROG; OTCQX:RHHBY), Basel, Switzerland Product: Kadcyla …

    Published on 8/11/2014
  • Kalydeco ivacaftor regulatory update

    Vertex Pharmaceuticals Inc. (NASDAQ:VRTX), Boston, Mass. Product: Kalydeco ivacaftor (VX-770) Business: Pulmonary Vertex said the European Commission approved cystic fibrosis drug Kalydeco ivacaftor in patients >=6 …

    Published on 8/11/2014
  • MiR-21 regulatory update

    Regulus Therapeutics Inc. (NASDAQ:RGLS), San Diego, Calif. Product: MiR-21 (anti-miR-21) (RG-012) (formerly antagomir-21) Business: Renal Regulus said FDA granted Orphan Drug designation to RG-012 to treat Alport …

    Published on 8/11/2014
  • Naltrexone SR/bupropion SR regulatory update

    Orexigen Therapeutics Inc. (NASDAQ:OREX), La Jolla, Calif. Product: Naltrexone SR/bupropion SR (NB32) (formerly Contrave) Business: Endocrine/Metabolic Orexigen said it received Day 180 questions from EMAs CHMP related …

    Published on 8/11/2014
  • Nuwiq simoctogog alfa regulatory update

    Octapharma AG, Lachen, Switzerland Product: Nuwiq simoctogog alfa, Human-cl rhFVIII Business: Hematology The European Commission approved Nuwiq simoctogog alfa from Octapharma to treat and prevent bleeding in patients …

    Published on 8/11/2014
  • Orbactiv oritavancin regulatory update

    The Medicines Co. (NASDAQ:MDCO), Parsippany, N.J. Product: Orbactiv oritavancin (formerly LY333328) Business: Infectious FDA approved an NDA from The Medicines Co. for Orbactiv oritavancin to treat acute bacterial skin …

    Published on 8/11/2014

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