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Chronological Index of : Regulatory

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  • Augment Bone Graft regulatory update

    Wright Medical Group Inc. (NASDAQ:WMGI), Arlington, Tenn. Product: Augment Bone Graft (formerly GEM OS1) Business: Transplant FDA issued an approvable letter to Wright Medical for a PMA for Augment Bone Graft for use as…

    Published on 11/24/2014
  • BioThrax regulatory update

    Emergent BioSolutions Inc. (NYSE:EBS), Rockville, Md. Product: BioThrax Business: Infectious Emergent submitted an sBLA to FDA for BioThrax for post-exposure prophylaxis (PEP) of disease resulting from suspected or …

    Published on 11/24/2014
  • Cerdelga eliglustat tartrate regulatory update

    Sanofi (Euronext:SAN; NYSE:SNY), Paris, France Product: Cerdelga eliglustat tartrate (formerly Genz-112638) Business: Endocrine/Metabolic EMAs CHMP recommended approval of Cerdelga eliglustat from Sanofi to treat Type I…

    Published on 11/24/2014
  • Cosentyx secukinumab regulatory update

    Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland Product: Cosentyx secukinumab (AIN457) Business: Autoimmune EMAs CHMP recommended approval of Cosentyx secukinumab from Novartis as first-line treatment of moderate …

    Published on 11/24/2014
  • Dronabinol regulatory update

    Insys Therapeutics Inc. (NASDAQ:INSY), Phoenix, Ariz. Product: Dronabinol Business: Gastrointestinal Last month, Insys said FDA refused to file an NDA for dronabinol for anorexia and chemotherapy-induced nausea and …

    Published on 11/24/2014
  • Dutetrabenazine regulatory update

    Auspex Pharmaceuticals Inc. (NASDAQ:ASPX), La Jolla, Calif. Product: Dutetrabenazine (SD-809) Business: Neurology FDA granted Orphan Drug designation to Auspexs SD-809 to treat Huntingtons disease (HD). The deuterium-…

    Published on 11/24/2014
  • Exviera dasabuvir regulatory update

    AbbVie Inc. (NYSE:ABBV), Chicago, Ill. Product: Exviera dasabuvir (ABT-333) Business: Infectious EMAs CHMP recommended approval for an all-oral, interferon-free treatment of Exviera dasabuvir and Viekirax ombitasvir/…

    Published on 11/24/2014
  • GC021109 regulatory update

    GliaCure Inc., Boston, Mass. Tufts University, Medford, Mass. Product: GC021109 Business: Neurology FDA granted Fast Track designation to GliaCures GC021109 to treat Alzheimers disease. The small molecule that …

    Published on 11/24/2014
  • Harvoni ledipasvir regulatory update

    Gilead Sciences Inc. (NASDAQ:GILD), Foster City, Calif. Product: Harvoni ledipasvir (GS-5885)/sofosbuvir (GS-7977) Business: Infectious The European Commission approved Harvoni ledipasvir/sofosbuvir from Gilead to treat…

    Published on 11/24/2014
  • Hysingla ER regulatory update

    Purdue Pharma L.P., Stamford, Conn. Product: Hysingla ER, hydrocodone bitartrate ER Business: Neurology FDA approved Hysingla ER, a once-daily, abuse-deterrent extended-release formulation of hydrocodone bitartrate, to …

    Published on 11/24/2014
  • Ig-plex Celiac DGP Panel regulatory update

    SQI Diagnostics Inc. (TSX-V:SQD; OTCQX:SQIDF), Toronto, Ontario Product: Ig-plex Celiac DGP Panel Business: Diagnostic FDA granted 510(k) clearance to SQI Diagnostics Ig-plex Celiac DGP Panel as an aid in diagnosing …

    Published on 11/24/2014
  • 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 11/24/2014
  • LB1148 regulatory update

    Leading BioSciences Inc., San Diego, Calif. Product: LB1148 Business: Infectious Leading BioSciences submitted a compassionate use IND to FDA for LB1148 to treat gastrointestinal breakdown and multi-organ failure …

    Published on 11/24/2014
  • Lemtrada alemtuzumab regulatory update

    BTG plc (LSE:BTG), London, U.K. Sanofi (Euronext:SAN; NYSE:SNY), Paris, France Product: Lemtrada alemtuzumab (MabCampath, Campath) Business: Autoimmune FDA approved a resubmitted sBLA for Lemtrada alemtuzumab from …

    Published on 11/24/2014
  • Macrilen macimorelin acetate regulatory update

    Aeterna Zentaris Inc. (TSX:AEZ; NASDAQ:AEZS), Quebec City, Quebec Product: Macrilen macimorelin acetate (AEZS-130) (formerly ARD-07) Business: Diagnostic FDA issued a complete response letter for Macrilen macimorelin …

    Published on 11/24/2014
  • MOR208 regulatory update

    MorphoSys AG (Xetra:MOR; Pink:MPSYF), Martinsried, Germany Xencor Inc. (NASDAQ:XNCR), Monrovia, Calif. Product: MOR208, MOR00208 (formerly XmAb5574) Business: Cancer FDA granted Fast Track designation to MorphoSys …

    Published on 11/24/2014
  • Natpara regulatory update

    NPS Pharmaceuticals Inc. (NASDAQ:NPSP), Bedminster, N.J. Product: Natpara (Preotact) (NPSP558 (PTH 1-84)) Business: Endocrine/Metabolic NPS submitted an MAA to EMA for Natpara to treat hypoparathyroidism. The …

    Published on 11/24/2014
  • Nuwiq simoctogog alfa regulatory update

    Octapharma AG, Lachen, Switzerland Product: Nuwiq simoctogog alfa, Human-cl rhFVIII Business: Hematology Health Canada approved Octaphamas Nuwiq recombinant FVIII (rFVIII) to treat and prevent bleeding in patients with …

    Published on 11/24/2014
  • Ofev nintedanib regulatory update

    Boehringer Ingelheim GmbH, Ingelheim, Germany Product: Ofev nintedanib (BIBF 1120) Business: Pulmonary EMAs CHMP recommended approval of Ofev nintedanib from Boehringer to treat idiopathic pulmonary fibrosis (IPF). Ofev…

    Published on 11/24/2014
  • Otezla apremilast regulatory update

    Celgene Corp. (NASDAQ:CELG), Summit, N.J. Product: Otezla apremilast (CC-10004) Business: Autoimmune EMAs CHMP recommended approval of Otezla apremilast from Celgene to treat active psoriatic arthritis and moderate to …

    Published on 11/24/2014
  • Posidur bupivacaine regulatory update

    Durect Corp. (NASDAQ:DRRX), Cupertino, Calif. Product: Posidur bupivacaine (formerly Optesia) Business: Neurology Durect said FDA indicated that only 1 additional soft tissue clinical trial of Posidur bupivacaine would …

    Published on 11/24/2014
  • Procoralan ivabradine regulatory update

    Ono Pharmaceutical Co. Ltd. (Tokyo:4528), Osaka, Japan Servier, Neuilly-sur-Seine, France Product: Procoralan ivabradine (ONO-1162) (formerly (S-16257) Business: Cardiovascular EMAs Pharmacovigilance Risk Assessment …

    Published on 11/24/2014
  • ReCell Spray-on-Skin regulatory update

    Avita Medical Ltd. (ASX:AVH), Perth, Australia Product: ReCell Spray-on-Skin Business: Dermatology The U.K.s NICE issued final guidance for Avitas ReCell Spray-On Skin system to improve healing in acute burns, …

    Published on 11/24/2014
  • RHB-105 regulatory update

    RedHill Biopharma Ltd. (Tel Aviv:RDHL; NASDAQ:RDHL), Ramat-Gan, Israel Product: RHB-105 (formerly Heliconda) Business: Infectious FDA granted Qualified Infections Disease Product (QIDP) designation to RHB-105 from …

    Published on 11/24/2014
  • Tenofovir alafenamide fumarate regulatory update

    Gilead Sciences Inc. (NASDAQ:GILD), Foster City, Calif. Product: Tenofovir alafenamide fumarate (TAF)/elvitegravir/cobicistat/emtricitabine (formerly GS-7340/elvitegravir/cobicistat/emtricitabine) Business: Infectious …

    Published on 11/24/2014

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