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Chronological Index of : Regulatory

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  • AAV8 vector encoding GUCY2D gene regulatory update

    Fondazione Telethon, Milano, Italy Product: AAV8 vector encoding GUCY2D gene Business: Ophthalmic The European Commission granted Orphan Drug designation for Fondazione Telethon's adeno-associated virus (AAV) serotype 8…

    Published on 4/28/2014
  • ABT-450 plus ritonavir/ombitasvir regulatory update

    Enanta Pharmaceuticals Inc. (NASDAQ:ENTA), Watertown, Mass. AbbVie Inc. (NYSE:ABBV), Chicago, Ill. Product: ABT-450 plus ritonavir/ombitasvir (ABT-267)/dasabuvir (ABT-333) (3 direct-acting-antiviral (3D) regimen) …

    Published on 4/28/2014
  • AcellBia rituximab regulatory update

    Biocad, Saint Petersburg, Russia Product: AcellBia rituximab (BCD-020) Business: Cancer Biocad said the Russian Ministry of Health approved the company's AcellBia, a biosimilar of rituximab for autoimmune and cancer …

    Published on 4/28/2014
  • Alimta pemetrexed regulatory update

    Eli Lilly and Co. (NYSE:LLY), Indianapolis, Ind. Product: Alimta pemetrexed Business: Cancer The U.K.'s NICE issued final guidance recommending against the use of Alimta pemetrexed from Eli Lilly for maintenance …

    Published on 4/28/2014
  • Alvocidib regulatory update

    Tolero Pharmaceuticals Inc., Lehi, Utah Sanofi (Euronext:SAN; NYSE:SNY), Paris, France Product: Alvocidib (flavopiridol) (formerly HMR 1275) Business: Cancer Tolero said FDA granted Orphan Drug designation for alvocidib…

    Published on 4/28/2014
  • Asfotase alfa regulatory update

    Alexion Pharmaceuticals Inc. (NASDAQ:ALXN), Cheshire, Conn. Product: Asfotase alfa (ENB-0040) Business: Endocrine/Metabolic Alexion disclosed in its 1Q14 earnings that it began submission of a rolling BLA to FDA for …

    Published on 4/28/2014
  • AZD9291 regulatory update

    AstraZeneca plc (LSE:AZN; NYSE:AZN), London, U.K. Product: AZD9291 Business: Cancer AstraZeneca disclosed in its 1Q14 earnings that earlier this month FDA granted breakthrough therapy designation to AZD9291 to treat …

    Published on 4/28/2014
  • BioThrax regulatory update

    Emergent BioSolutions Inc. (NYSE:EBS), Rockville, Md. Product: BioThrax Business: Infectious FDA granted Orphan Drug designation for BioThrax from Emergent for post-exposure prophylaxis (PEP) of anthrax resulting from …

    Published on 4/28/2014
  • Ceftolozane/tazobactam regulatory update

    Cubist Pharmaceuticals Inc. (NASDAQ:CBST), Lexington, Mass. Astellas Pharma Inc. (Tokyo:4503), Tokyo, Japan Product: Ceftolozane/tazobactam (formerly CXA-201) Business: Infectious Cubist submitted an NDA to FDA for …

    Published on 4/28/2014
  • cobas HPV test regulatory update

    Roche (SIX:ROG; OTCQX:RHHBY), Basel, Switzerland Product: cobas HPV test (cobas 4800 HPV test) Business: Diagnostic FDA approved a PMA supplement from Roche to expand approval of the cobas HPV test to include primary …

    Published on 4/28/2014
  • Cyramza ramucirumab regulatory update

    Eli Lilly and Co. (NYSE:LLY), Indianapolis, Ind. Product: Cyramza ramucirumab (LY3009806, IMC-1121B) Business: Cancer FDA approved Cyramza ramucirumab from Eli Lilly as monotherapy for advanced stomach cancer or …

    Published on 4/28/2014
  • Cysteamine bitartrate regulatory update

    Raptor Pharmaceutical Corp. (NASDAQ:RPTP), Novato, Calif. Product: Cysteamine bitartrate (Procysbi cysteamine bitartrate delayed-release capsules) (RP103) Business: Cancer The European Commission granted Orphan Drug …

    Published on 4/28/2014
  • Eteplirsen regulatory update

    Sarepta Therapeutics Inc. (NASDAQ:SRPT), Cambridge, Mass. Product: Eteplirsen (AVI-4658) Business: Musculoskeletal Sarepta said it plans to submit an NDA to FDA seeking accelerated approval of eteplirsen to treat …

    Published on 4/28/2014
  • Giotrif afatinib regulatory update

    Boehringer Ingelheim GmbH, Ingelheim, Germany Product: Giotrif afatinib (Gilotrif, Tomtovok) (BIBW 2992) Business: Cancer The U.K.'s NICE issued final guidance recommending the use of Giotrif afatinib from Boehringer …

    Published on 4/28/2014
  • Incruse Ellipta umeclidinium bromide regulatory update

    GlaxoSmithKline plc (LSE:GSK; NYSE:GSK), London, U.K. Product: Incruse Ellipta umeclidinium bromide Business: Pulmonary GlaxoSmithKline said Canada approved Incruse Ellipta umeclidinium bromide for the long-term, once-…

    Published on 4/28/2014
  • ISIS-TTRRx regulatory update

    Isis Pharmaceuticals Inc. (NASDAQ:ISIS), Carlsbad, Calif. Product: ISIS-TTRRx Business: Endocrine/Metabolic The European Commission granted Orphan Drug designation to ISIS-TTRRx from Isis to treat transthyretin (TTR) …

    Published on 4/28/2014
  • 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 4/28/2014
  • Lyra Direct Strep Assay regulatory update

    Quidel Corp. (NASDAQ:QDEL), San Diego, Calif. Product: Lyra Direct Strep Assay Business: Diagnostic FDA granted 510(k) clearance to Quidel's Lyra Direct Strep Assay to detect and differentiate between pyogenic Group A …

    Published on 4/28/2014
  • Mekinist trametinib regulatory update

    Japan Tobacco Inc. (Tokyo:2914), Tokyo, Japan GlaxoSmithKline plc (LSE:GSK; NYSE:GSK), London, U.K. Product: Mekinist trametinib (GSK1120212) Business: Cancer EMA's CHMP backed approval of Mekinist trametinib from …

    Published on 4/28/2014
  • MoxDuo IR morphine/oxycodone regulatory update

    Endo International plc (NASDAQ:ENDP; TSX:ENL), Dublin, Ireland QRxPharma Ltd. (ASX:QRX; OTCQX:QRXPY), North Sydney, Australia Teva Pharmaceutical Industries Ltd. (NYSE:TEVA), Petah Tikva, Israel Product: MoxDuo IR …

    Published on 4/28/2014
  • Neo-GAA regulatory update

    Sanofi (Euronext:SAN; NYSE:SNY), Paris, France Product: Neo-GAA Business: Endocrine/Metabolic The European Commission granted Orphan Drug designation to Neo-GAA from Sanofi's Genzyme Corp. unit to treat Pompe's disease.…

    Published on 4/28/2014
  • PXT3003 regulatory update

    Pharnext S.A.S., Issy-Les-Moulineaux, France Product: PXT3003 Business: Neurology FDA and the European Commission granted Orphan Drug designation to PXT3003 to treat Charcot-Marie-Tooth (CMT) disease Type IA. The …

    Published on 4/28/2014
  • Relistor methylnaltrexone regulatory update

    Progenics Pharmaceuticals Inc. (NASDAQ:PGNX), Tarrytown, N.Y. Salix Pharmaceuticals Inc. (NASDAQ:SLXP), Raleigh, N.C. Ono Pharmaceutical Co. Ltd. (Tokyo:4528), Osaka, Japan Product: Relistor methylnaltrexone (MNTX) (MOA…

    Published on 4/28/2014
  • Soliris eculizumab regulatory update

    Alexion Pharmaceuticals Inc. (NASDAQ:ALXN), Cheshire, Conn. Product: Soliris eculizumab Business: Transplant The European Commission granted Orphan Drug designation to Alexion's Soliris eculizumab to prevent graft …

    Published on 4/28/2014
  • Stribild elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate regulatory update

    Gilead Sciences Inc. (NASDAQ:GILD), Foster City, Calif. Japan Tobacco Inc. (Tokyo:2914), Tokyo, Japan Product: Stribild elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (formerly Quad) Business: …

    Published on 4/28/2014

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