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Chronological Index of : Regulatory

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  • Amikacin Inhale regulatory update

    Nektar Therapeutics (NASDAQ:NKTR), San Francisco, Calif. Bayer AG (Xetra:BAYN), Leverkusen, Germany Product: Amikacin Inhale, NKTR-061, BAY41-6551 Business: Infectious FDA granted Qualified Infectious Disease Product (…

    Published on 12/15/2014
  • Cannabidiol regulatory update

    Insys Therapeutics Inc. (NASDAQ:INSY), Phoenix, Ariz. Product: Cannabidiol Business: Neurology FDA granted Orphan Drug designation to Insyscannabidiol (CBD) to treat pediatric schizophrenia. Insys plans to start a Phase…

    Published on 12/15/2014
  • CAT-1004 regulatory update

    Catabasis Pharmaceuticals Inc., Cambridge, Mass. Product: CAT-1004 Business: Musculoskeletal FDA granted Orphan Drug designation to CAT-1004 from Catabasis to treat Duchenne muscular dystrophy (DMD). Catabasis plans to …

    Published on 12/15/2014
  • CCX168 regulatory update

    ChemoCentryx Inc. (NASDAQ:CCXI), Mountain View, Calif. Product: CCX168 Business: Hematology ChemoCentryx said FDA granted Orphan Drug designation to CCX168 to treat atypical hemolytic uremic syndrome (aHUS) and the …

    Published on 12/15/2014
  • Ciprofloxacin dry powder for inhalation regulatory update

    Bayer AG (Xetra:BAYN), Leverkusen, Germany Product: Ciprofloxacin dry powder for inhalation (DPI) Business: Pulmonary FDA granted Qualified Infectious Disease Product (QIDP) designation to ciprofloxacin dry powder for …

    Published on 12/15/2014
  • Cyramza ramucirumab regulatory update

    Eli Lilly and Co. (NYSE:LLY), Indianapolis, Ind. Product: Cyramza ramucirumab (LY3009806, IMC-1121B) Business: Cancer FDA approved an sBLA from Eli Lilly for Cyramza ramucirumab in combination with docetaxel to treat …

    Published on 12/15/2014
  • Duaklir Genuair aclidinium bromide/formoterol fumarate regulatory update

    Actavis plc (NYSE:ACT), Dublin, Ireland Kyorin Pharmaceutical Co. Ltd. (Tokyo:4569), Tokyo, Japan AstraZeneca plc (LSE:AZN; NYSE:AZN), London, U.K. Product: Duaklir Genuair aclidinium bromide/formoterol fumarate (…

    Published on 12/15/2014
  • Epi proColon 2 regulatory update

    BioChain Institute Inc., Newark, Calif. Epigenomics AG (Xetra:ECX; OTCQX:EPGNY), Berlin, Germany Product: Epi proColon 2.0 Business: Diagnostic BioChain and Epigenomics said the China Food and Drug Administration (CFDA)…

    Published on 12/15/2014
  • Fluad regulatory update

    Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland Product: Fluad Business: Infectious EMAs Pharmacovigilance Risk Assessment Committee (PRAC) concluded there is no evidence that Novartis Fluad influenza vaccine …

    Published on 12/15/2014
  • Gattex teduglutide regulatory update

    NPS Pharmaceuticals Inc. (NASDAQ:NPSP), Bedminster, N.J. Product: Gattex teduglutide ( RevestiveEU) (ALX-0600) Business: Gastrointestinal Japan granted Orphan Drug designation to teduglutide from NPS to treat short …

    Published on 12/15/2014
  • Iclusig ponatinib regulatory update

    Ariad Pharmaceuticals Inc. (NASDAQ:ARIA), Cambridge, Mass. Product: Iclusig ponatinib (formerly AP24534) Business: Cancer Australias Therapeutic Goods Administration (TGA) approved Iclusig ponatinib from Ariad to treat …

    Published on 12/15/2014
  • Isavuconazole regulatory update

    Basilea Pharmaceutica AG (SIX:BSLN), Basel, Switzerland Astellas Pharma Inc. (Tokyo:4503), Tokyo, Japan Product: Isavuconazole (BAL8557) Business: Infectious FDAs Anti-Infective Drugs Advisory Committee will meet on Jan…

    Published on 12/15/2014
  • Mitizax regulatory update

    ALK-Abello A/S (CSE:ALK-Beta), Horsholm, Denmark Torii Pharmaceutical Co. Ltd. (Tokyo:4551), Tokyo, Japan Merck & Co. Inc. (NYSE:MRK), Whitehouse Station, N.J. Product: Mitizax (House Dust Mite Allergy Immunotherapy …

    Published on 12/15/2014
  • Nebido regulatory update

    Endo International plc (NASDAQ:ENDP; TSX:ENL), Dublin, Ireland Bayer AG (Xetra:BAYN), Leverkusen, Germany Product: Nebido ( Aveed) testosterone Business: Endocrine/Metabolic Perrigo Co. plc (NYSE:PRGO; Tel Aviv:PRGO, …

    Published on 12/15/2014
  • Once-monthly Signifor pasireotide regulatory update

    Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland Product: Once-monthly Signifor pasireotide Business: Endocrine/Metabolic The European Commission approved once-monthly Signifor pasireotide from Novartis to treat …

    Published on 12/15/2014
  • 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 CHMP recommended measures to reduce …

    Published on 12/15/2014
  • Retinal pigment epithelial regulatory update

    Ocata Therapeutics Inc. (OTCBB:OCAT), Marlborough, Mass. Product: Retinal pigment epithelial (RPE) cell therapy Business: Ophthalmic Ocata said EMA classified the companys RPE cell therapy as an advanced therapy …

    Published on 12/15/2014
  • Simponi golimumab regulatory update

    Johnson & Johnson (NYSE:JNJ), New Brunswick, N.J. Product: Simponi golimumab Business: Autoimmune Johnson & Johnsons Janssen Biologics Beta.V. unit submitted a Type II variation to EMA for subcutaneous Simponi golimumab…

    Published on 12/15/2014
  • Testosterone medicines regulatory update

    European Medicines Agency (EMA), London, U.K. Product: Testosterone medicines Business: Endocrine/Metabolic EMAs Coordination Group for Mutual Recognition and Decentralised Procedures-Human (CMDh) said there is no …

    Published on 12/15/2014
  • Tresiba insulin degludec regulatory update

    Novo Nordisk A/S (CSE:NVO; NYSE:NVO), Bagsvaerd, Denmark Product: Tresiba insulin degludec (NN1250) Business: Endocrine/Metabolic Germanys Federal Joint Committee (G-BA) issued a final benefit assessment stating that …

    Published on 12/15/2014
  • Valproate-containing medicines regulatory update

    European Medicines Agency (EMA), London, U.K. Product: Valproate-containing medicines Business: Neurology EMAs Coordination Group for Mutual Recognition and Decentralised Procedures-Human (CMDh) endorsed a …

    Published on 12/15/2014
  • Victoza liraglutide regulatory update

    Novo Nordisk A/S (CSE:NVO; NYSE:NVO), Bagsvaerd, Denmark Product: Victoza liraglutide (NN2211) Business: Endocrine/Metabolic EMAs CHMP recommended expanding the label of Victoza liraglutide from Novo Nordisk to include …

    Published on 12/15/2014
  • Vimizim elosulfase alfa regulatory update

    BioMarin Pharmaceutical Inc. (NASDAQ:BMRN), Novato, Calif. Product: Vimizim elosulfase alfa (BMN-110) (formerly GALNS) Business: Endocrine/Metabolic BioMarin said Brazil and Australia approved Vimizim elosulfase alfa to…

    Published on 12/15/2014
  • Yondelis trabectedin regulatory update

    PharmaMar S.A., Madrid, Spain Taiho Pharmaceutical Co. Ltd., Tokyo, Japan Johnson & Johnson (NYSE:JNJ), New Brunswick, N.J. Product: Yondelis trabectedin (ET-743) Business: Cancer Johnson & Johnsons Janssen Research & …

    Published on 12/15/2014
  • Zarzio filgrastim regulatory update

    Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland Product: Zarzio filgrastim (EP2006) Business: Hematology FDAs Oncologic Drugs Advisory Committee will meet Jan. 7, 2015, to discuss a BLA from Novartis Sandoz Inc. …

    Published on 12/15/2014

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