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Chronological Index of : Regulatory

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  • Zonegran zonisamide regulatory update

    Sumitomo Dainippon Pharma Co. Ltd. (Tokyo:4506), Osaka, Japan Eisai Co. Ltd. (Tokyo:4523), Tokyo, Japan Product: Zonegran zonisamide (Excegran) (E2090, AD-810N) Business: Neurology Russia approved Zonegran zonisamide …

    Published on 12/15/2014
  • AVX-470 regulatory update

    Avaxia Biologics Inc., Lexington, Mass. Product: AVX-470 Business: Autoimmune FDA granted Orphan Drug designation to AVX-470 from Avaxia to treat pediatric ulcerative colitis (UC). The oral inhibitor of tumor necrosis …

    Published on 12/8/2014
  • BAX 855 regulatory update

    Nektar Therapeutics (NASDAQ:NKTR), San Francisco, Calif. Baxter International Inc. (NYSE:BAX), Deerfield, Ill. Product: BAX 855 Business: Hematology Baxter submitted a BLA to FDA for BAX 855 to treat hemophilia A. …

    Published on 12/8/2014
  • Blincyto blinatumomab regulatory update

    Amgen Inc. (NASDAQ:AMGN), Thousand Oaks, Calif. Astellas Pharma Inc. (Tokyo:4503), Tokyo, Japan Product: Blincyto blinatumomab (AMG 103) (formerly MT103) Business: Cancer FDA granted accelerated approval of Blincyto …

    Published on 12/8/2014
  • Cobas Strep A test regulatory update

    Roche (SIX:ROG; OTCQX:RHHBY), Basel, Switzerland Product: Cobas Strep A test Business: Diagnostic FDA granted 510(k) clearance to Roches cobas Strep A test to detect group A streptococcus bacterial DNA in throat swab …

    Published on 12/8/2014
  • CSI Glucagon regulatory update

    Xeris Pharmaceuticals Inc., Austin, Texas Product: CSI Glucagon Business: Endocrine/Metabolic FDA and the European Commission granted Orphan Drug designation to CSI Glucagon from Xeris to prevent severe, persistent …

    Published on 12/8/2014
  • Daklinza daclatasvir regulatory update

    Bristol-Myers Squibb Co. (NYSE:BMY), New York, N.Y. Product: Daklinza daclatasvir (BMS-790052) Business: Infectious FDA issued a complete response letter for daclatasvir from Bristol-Myers Squibb to treat HCV genotype …

    Published on 12/8/2014
  • Dupilumab regulatory update

    Regeneron Pharmaceuticals Inc. (NASDAQ:REGN), Tarrytown, N.Y. Sanofi (Euronext:SAN; NYSE:SNY), Paris, France Product: Dupilumab (REGN668, SAR231893) Business: Dermatology The partners said FDA granted breakthrough …

    Published on 12/8/2014
  • 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 Japan approved Eylea …

    Published on 12/8/2014
  • Gazyva obinutuzumab 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 12/8/2014
  • Hemopurifier regulatory update

    Aethlon Medical Inc. (OTCQB:AEMD), San Diego, Calif. Product: Hemopurifier Business: Infectious Aethlon said it received updated guidance from FDA that the company can provide Hemopurifier to treat Ebola infection in …

    Published on 12/8/2014
  • Invega Sustenna paliperidone palmitate regulatory update

    Alkermes plc (NASDAQ:ALKS), Dublin, Ireland Johnson & Johnson (NYSE:JNJ), New Brunswick, N.J. Product: Invega Sustenna paliperidone palmitate Business: Neurology Johnson & Johnsons Janssen Research & Development LLC …

    Published on 12/8/2014
  • Invega Sustenna regulatory update

    Johnson & Johnson (NYSE:JNJ), New Brunswick, N.J. Product: Invega Sustenna (paliperidone palmitate) (Xeplion) Business: Neurology FDA approved 2 sNDAs from Johnson & Johnson for once-monthly Invega Sustenna paliperidone…

    Published on 12/8/2014
  • Irinotecan regulatory update

    Merrimack Pharmaceuticals Inc. (NASDAQ:MACK), Cambridge, Mass. PharmaEngine Inc. (GreTai:4162), Taipei, Taiwan Baxter International Inc. (NYSE:BAX), Deerfield, Ill. Product: Irinotecan (nal-IRI) (PEP02, MM-398) Business…

    Published on 12/8/2014
  • Ixazomib regulatory update

    Takeda Pharmaceutical Co. Ltd. (Tokyo:4502), Osaka, Japan Product: Ixazomib (MLN9708) Business: Endocrine/Metabolic FDA granted breakthrough therapy designation to ixazomib from Takeda to treat relapsed or refractory …

    Published on 12/8/2014
  • Jakafi ruxolitinib regulatory update

    Incyte Corp. (NASDAQ:INCY), Wilmington, Del. Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland Product: Jakafi ruxolitinib (INCB18424) Business: Hematology FDA approved an sNDA from Incyte for Jakafi ruxolitinib to …

    Published on 12/8/2014
  • Jardiance empagliflozin regulatory update

    Boehringer Ingelheim GmbH, Ingelheim, Germany Eli Lilly and Co. (NYSE:LLY), Indianapolis, Ind. Product: Jardiance empagliflozin (BI-10773) Business: Endocrine/Metabolic Germanys Institute for Quality and Efficiency in …

    Published on 12/8/2014
  • JCAR015 regulatory update

    Juno Therapeutics Inc., Seattle, Wash. Product: JCAR015 (19-28z CAR T cells) Business: Cancer FDA granted breakthrough therapy designation to JCAR015 from Juno to treat relapsed or refractory Beta cell acute …

    Published on 12/8/2014
  • Lymphoseek tilmanocept regulatory update

    Hainan Sinotau Pharmaceutical Co. Ltd, Beijing, China Navidea Biopharmaceuticals Inc. (NYSE-M:NAVB), Dublin, Ohio Product: Lymphoseek tilmanocept Business: Diagnostic The European Commission approved Lymphoseek …

    Published on 12/8/2014
  • MecA XpressFISH test regulatory update

    AdvanDx Inc., Woburn, Mass. Product: MecA XpressFISH test Business: Diagnostic FDA granted 510(k) clearance for the mecA XpressFISH test from AdvanDx to detect mecA mRNA from methicillin-resistant Staphylococcus aureus …

    Published on 12/8/2014
  • NovoNorm repaglinide regulatory update

    Sumitomo Dainippon Pharma Co. Ltd. (Tokyo:4506), Osaka, Japan Novo Nordisk A/S (CSE:NVO; NYSE:NVO), Bagsvaerd, Denmark Product: NovoNorm repaglinide (Prandin, Surepost) (SMP-508) Business: Endocrine/Metabolic Japan …

    Published on 12/8/2014
  • Omarigliptin regulatory update

    Merck & Co. Inc. (NYSE:MRK), Whitehouse Station, N.J. Product: Omarigliptin (MK-3102) Business: Endocrine/Metabolic Merck submitted an NDA in Japan for omarigliptin to treat Type II diabetes. It is the first regulatory …

    Published on 12/8/2014
  • Oral neratinib regulatory update

    Puma Biotechnology Inc. (NYSE:PBYI), Los Angeles, Calif. Pfizer Inc. (NYSE:PFE), New York, N.Y. Product: Oral neratinib (HKI-272, PB272) Business: Cancer Puma said it will delay to 1Q16 from 1H15 its NDA submission for …

    Published on 12/8/2014
  • Otezla apremilast regulatory update

    Celgene Corp. (NASDAQ:CELG), Summit, N.J. Product: Otezla apremilast (CC-10004) Business: Autoimmune Last month, Health Canada approved Otezla apremilast from Celgene to treat moderate to severe plaque psoriasis in …

    Published on 12/8/2014
  • Palovarotene regulatory update

    Clementia Pharmaceuticals Inc., Dorval, Quebec Roche (SIX:ROG; OTCQX:RHHBY), Basel, Switzerland Product: Palovarotene (formerly RG667, CLM-001) Business: Musculoskeletal The European Commission granted Orphan Drug …

    Published on 12/8/2014

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