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Chronological Index of : Regulatory

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  • Aubagio teriflunomide regulatory update

    Sanofi (Euronext:SAN; NYSE:SNY), Paris, France Product: Aubagio teriflunomide Business: Autoimmune On Jan. 2, Germany's Institute for Quality and Efficiency in Healthcare (IQWiG) said Aubagio teriflunomide from the …

    Published on 1/6/2014
  • BRACAnalysis regulatory update

    Myriad Genetics Inc. (NASDAQ:MYGN), Salt Lake City, Utah Product: BRACAnalysis Business: Diagnostic On Dec. 30, 2013, CMS reiterated a 2014 Medicare reimbursement rate for genetic tests for breast cancer 1 early onset (…

    Published on 1/6/2014
  • Brintellix vortioxetine regulatory update

    H. Lundbeck A/S (CSE:LUN), Copenhagen, Denmark Takeda Pharmaceutical Co. Ltd. (Tokyo:4502), Osaka, Japan Product: Brintellix vortioxetine (formerly Lu AA21004) Business: Neurology On Dec. 27, 2013, the European …

    Published on 1/6/2014
  • Cangrelor regulatory update

    The Medicines Co. (NASDAQ:MDCO), Parsippany, N.J. AstraZeneca plc (LSE:AZN; NYSE:AZN), London, U.K. Product: Cangrelor (formerly AR-C69931MX) Business: Cardiovascular On Dec. 23, 2013, The Medicines Co. said EMA …

    Published on 1/6/2014
  • Cervarix regulatory update

    GlaxoSmithKline plc (LSE:GSK; NYSE:GSK), London, U.K. Product: Cervarix Business: Infectious On Dec. 20, 2013, the European Commission approved a 2-dose schedule of GlaxoSmithKline's Cervarix given 6 months apart to …

    Published on 1/6/2014
  • CompleoTRT regulatory update

    Trimel Pharmaceuticals Corp. (TSX:TRL), Mississauga, Ontario Product: CompleoTRT (formerly TBS-1) Business: Endocrine/Metabolic On Dec. 19, 2013, Trimel said that after a discussion with FDA, it will amend its proposed …

    Published on 1/6/2014
  • Dalbavancin regulatory update

    Durata Therapeutics Inc. (NASDAQ:DRTX), Chicago, Ill. Product: Dalbavancin (RQ-00000002) Business: Infectious On Dec. 23, 2013, Durata said EMA accepted for review an MAA for dalbavancin to treat complicated skin and …

    Published on 1/6/2014
  • Eliquis apixaban regulatory update

    Bristol-Myers Squibb Co. (NYSE:BMY), New York, N.Y. Pfizer Inc. (NYSE:PFE), New York, N.Y. Product: Eliquis apixaban (BMS-562247-01) Business: Cardiovascular On Dec. 19, 2013, the partners said FDA accepted for review …

    Published on 1/6/2014
  • Entyvio vedolizumab regulatory update

    Takeda Pharmaceutical Co. Ltd. (Tokyo:4502), Osaka, Japan Product: Entyvio vedolizumab (MLN0002) Business: Autoimmune On Dec. 24, 2013, Takeda said FDA extended by 3 months the review of a BLA for Entyvio vedolizumab to…

    Published on 1/6/2014
  • Envarsus tacrolimus regulatory update

    Veloxis Pharmaceuticals A/S (CSE:VELO), Horsholm, Denmark Product: Envarsus tacrolimus (formerly LCP-Tacro) Business: Transplant On Dec. 30, 2013, Veloxis said it submitted an NDA to FDA for Envarsus tacrolimus to …

    Published on 1/6/2014
  • Epi proColon regulatory update

    Epigenomics AG (Xetra:ECX), Berlin, Germany Quest Diagnostics Inc. (NYSE:DGX), Madison, N.J. Sysmex Corp. (Tokyo:6869), Kobe, Japan Warnex Inc. (NEX:WNX), Dorval, Quebec Abbott Laboratories (NYSE:ABT), Abbott Park, Ill.…

    Published on 1/6/2014
  • EpiFix amniotic membrane allograft regulatory update

    MiMedx Group Inc. (NASDAQ:MDXG), Marietta, Ga. Product: EpiFix amniotic membrane allograft Business: Dermatology On Dec. 12, 2013, MiMedx said it received reimbursement coverage from Medicare contractor CGS …

    Published on 1/6/2014
  • Erbitux cetuximab regulatory update

    Merck KGaA (Xetra:MRK), Darmstadt, Germany Bristol-Myers Squibb Co. (NYSE:BMY), New York, N.Y. Eli Lilly and Co. (NYSE:LLY), Indianapolis, Ind. Product: Erbitux cetuximab Business: Cancer On Dec. 23, 2013, Merck's Merck…

    Published on 1/6/2014
  • 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 Germany's Institute for …

    Published on 1/6/2014
  • Firmagon degarelix regulatory update

    Astellas Pharma Inc. (Tokyo:4503), Tokyo, Japan Ferring Pharmaceuticals A/S, Saint-Prex, Switzerland Product: Firmagon degarelix (Gonax) (ASP3550) Business: Cancer On Dec. 27, 2013, the U.K.'s NICE issued draft guidance…

    Published on 1/6/2014
  • Helixate NexGen regulatory update

    CSL Ltd. (ASX:CSL), Melbourne, Australia Bayer AG (Xetra:BAYN), Leverkusen, Germany Product: Helixate NexGen (Helixate FS) Business: Hematology On Dec. 20, 2013, EMA's CHMP endorsed recommendations from the agency's …

    Published on 1/6/2014
  • Heplisav regulatory update

    Dynavax Technologies Corp. (NASDAQ:DVAX), Berkeley, Calif. Product: Heplisav (V270) Business: Infectious On Dec. 19, 2013, Dynavax said that during 4Q13 it submitted its response to EMA's Day 120 list of questions …

    Published on 1/6/2014
  • Inavir laninamivir octanoate regulatory update

    Biota Pharmaceuticals Inc. (NASDAQ:BOTA), Alpharetta, Ga. Daiichi Sankyo Co. Ltd. (Tokyo:4568), Tokyo, Japan Product: Inavir laninamivir octanoate (CS-8958) Business: Infectious On Dec. 20, 2013, Daiichi said Japan …

    Published on 1/6/2014
  • Izba travoprost regulatory update

    Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland Product: Izba travoprost (Travatan Z) Business: Ophthalmic On Dec. 19, 2013, EMA's CHMP recommended approval of an MAA from Novartis' Alcon Inc. division for 30 g/mL …

    Published on 1/6/2014
  • Jentadueto linagliptin/metformin regulatory update

    Boehringer Ingelheim GmbH, Ingelheim, Germany Eli Lilly and Co. (NYSE:LLY), Indianapolis, Ind. Product: Jentadueto linagliptin/metformin Business: Endocrine/Metabolic On Dec. 18, 2013, EMA's CHMP recommended approval of…

    Published on 1/6/2014
  • Jetrea ocriplasmin regulatory update

    ThromboGenics N.V. (Euronext:THR), Leuven, Belgium Product: Jetrea ocriplasmin (formerly Microplasmin) Business: Ophthalmic On Dec. 27, 2013, ThromboGenics said the Canadian Agency for Drugs and Technologies in Health (…

    Published on 1/6/2014
  • Kogenate Bayer regulatory update

    Bayer AG (Xetra:BAYN), Leverkusen, Germany Product: Kogenate Bayer (Kogenate FS) (BAY14-2222) Business: Hematology On Dec. 20, 2013, EMA's CHMP endorsed recommendations from the agency's Pharmacovigilance Risk …

    Published on 1/6/2014
  • Lemtrada alemtuzumab regulatory update

    BTG plc (LSE:BTG), London, U.K. Sanofi (Euronext:SAN; NYSE:SNY), Paris, France Product: Lemtrada alemtuzumab (Campath, MabCampath) Business: Autoimmune On Dec. 30, 2013, FDA issued a complete response letter for an sBLA…

    Published on 1/6/2014
  • LY2963016 regulatory update

    Boehringer Ingelheim GmbH, Ingelheim, Germany Eli Lilly and Co. (NYSE:LLY), Indianapolis, Ind. Product: LY2963016 Business: Endocrine/Metabolic On Dec. 21, 2013, Eli Lilly and partner Boehringer Ingelheim said FDA …

    Published on 1/6/2014
  • Lymphoseek tilmanocept regulatory update

    Navidea Biopharmaceuticals Inc. (NYSE-M:NAVB), Dublin, Ohio Product: Lymphoseek tilmanocept Business: Diagnostic On Dec. 17, 2013, Navidea said it submitted an sNDA for Lymphoseek tilmanocept for sentinel lymph node …

    Published on 1/6/2014

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