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Chronological Index of : Regulatory

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  • Bempedoic acid regulatory update

    Esperion Therapeutics Inc. (NASDAQ:ESPR), Ann Arbor, Mich. Product: Bempedoic acid (ETC-1002) Business: Endocrine/Metabolic Esperion said FDA lifted a 2012 partial clinical hold of hypercholesterolemia candidate ETC-…

    Published on 7/13/2015
  • CAT-1004 regulatory update

    Catabasis Pharmaceuticals Inc. (NASDAQ:CATB), Cambridge, Mass. Product: CAT-1004 Business: Musculoskeletal FDA granted Fast Track designation to Catabasis CAT-1004 to treat Duchenne muscular dystrophy (DMD). The …

    Published on 7/13/2015
  • Cobimetinib regulatory update

    Exelixis Inc. (NASDAQ:EXEL), South San Francisco, Calif. Genentech Inc., South San Francisco, Calif. Roche (SIX:ROG; OTCQX:RHHBY), Basel, Switzerland Product: Cobimetinib (RG7421, GDC-0973) (formerly XL518) Business: …

    Published on 7/13/2015
  • Drisapersen regulatory update

    BioMarin Pharmaceutical Inc. (NASDAQ:BMRN), Novato, Calif. Product: Drisapersen (2402968, PRO051, GSK2402968) Business: Musculoskeletal FDA and EMA accepted for review applications from BioMarin for drisapersen to treat…

    Published on 7/13/2015
  • Entresto sacubitril/valsartan regulatory update

    Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland Product: Entresto sacubitril/valsartan (LCZ696) Business: Cardiovascular FDA approved an NDA from Novartis for Entresto sacubitril/valsartan to reduce the risk of …

    Published on 7/13/2015
  • Eteplirsen regulatory update

    Sarepta Therapeutics Inc. (NASDAQ:SRPT), Cambridge, Mass. Product: Eteplirsen (AVI-4658) Business: Musculoskeletal Sarepta completed submission of a rolling NDA to FDA for eteplirsen to treat Duchenne muscular dystrophy…

    Published on 7/13/2015
  • 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 Regeneron and Bayer said Japan…

    Published on 7/13/2015
  • Febuxostat regulatory update

    Ipsen Group (Euronext:IPN; Pink:IPSEY), Boulogne-Billancourt, France Menarini Group, Florence, Italy Teijin Pharma Ltd., Tokyo, Japan Product: Febuxostat (Adenuric - EU, Uloric) (TMX-67) Business: Endocrine/Metabolic …

    Published on 7/13/2015
  • Flubok regulatory update

    Protein Sciences Corp., Meriden, Conn. Product: Flubok (UMN-0502, ASP7374) Business: Infectious FDA approved Flubok seasonal influenza vaccine for the 2015-16 flu season in adults. The company expects to launch the …

    Published on 7/13/2015
  • Fycompa perampanel regulatory update

    Eisai Co. Ltd. (Tokyo:4523), Tokyo, Japan Product: Fycompa perampanel (E2007) Business: Neurology FDA approved an sNDA from Eisai for Fycompa perampanel as an adjunctive therapy to treat primary generalized tonic-clonic…

    Published on 7/13/2015
  • Galafold migalastat regulatory update

    Amicus Therapeutics Inc. (NASDAQ:FOLD), Cranbury, N.J. Product: Galafold migalastat (AT1001) (formerly Amigal) Business: Endocrine/Metabolic EMA accepted for review an MAA from Amicus for Galafold migalastat to treat …

    Published on 7/13/2015
  • Hetlioz tasimelteon regulatory update

    Vanda Pharmaceuticals Inc. (NASDAQ:VNDA), Washington, D.C. Bristol-Myers Squibb Co. (NYSE:BMY), New York, N.Y. Product: Hetlioz tasimelteon (VEC-162) Business: Neurology The European Commission approved an MAA from …

    Published on 7/13/2015
  • 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 7/13/2015
  • Kengreal cangrelor regulatory update

    The Medicines Co. (NASDAQ:MDCO), Parsippany, N.J. AstraZeneca plc (LSE:AZN; NYSE:AZN), London, U.K. Product: Kengreal cangrelor (Kengrexal) (formerly AR-C69931MX) Business: Cardiovascular FDA approved an NDA from The …

    Published on 7/13/2015
  • Kovaltry regulatory update

    Bayer AG (Xetra:BAYN), Leverkusen, Germany Product: Kovaltry (BAY 81-8973) Business: Hematology Bayers Bayer Yakuhin Ltd. subsidiary submitted an application in Japan for BAY 81-8973 to treat hemophilia A. The …

    Published on 7/13/2015
  • Lantus XR insulin glargine regulatory update

    Sanofi (Euronext:SAN; NYSE:SNY), Paris, France Product: Lantus XR insulin glargine (Toujeo) (formerly U300) Business: Endocrine/Metabolic Sanofi said Japan approved Lantus XR insulin glargine to treat Type I and II …

    Published on 7/13/2015
  • Levemir insulin detemir regulatory update

    Novo Nordisk A/S (CSE:NVO; NYSE:NVO), Bagsvaerd, Denmark Product: Levemir insulin detemir Business: Endocrine/Metabolic EMAs CHMP recommended extending the label for Levemir insulin detemir from Novo Nordisk to treat …

    Published on 7/13/2015
  • Lixiana edoxaban regulatory update

    Daiichi Sankyo Co. Ltd. (Tokyo:4568), Tokyo, Japan Product: Lixiana edoxaban (Savaysa, DU-176b) Business: Cardiovascular The European Commission approved an MAA from Daiichi Sankyo for Lixiana edoxaban to prevent stroke…

    Published on 7/13/2015
  • Necitumumab regulatory update

    Eli Lilly and Co. (NYSE:LLY), Indianapolis, Ind. Product: Necitumumab (LY3012211, IMC-11F8) Business: Cancer Panelists on FDAs Oncologic Drugs Advisory Committee (ODAC) reviewing a BLA for necitumumab from Eli Lilly to …

    Published on 7/13/2015
  • Obeticholic acid regulatory update

    Intercept Pharmaceuticals Inc. (NASDAQ:ICPT), New York, N.Y. Product: Obeticholic acid (OCA) (DSP-1747) (formerly INT-747, 6ECDCA) Business: Hepatic Intercept said it submitted an NDA to FDA and that EMA accepted an MAA…

    Published on 7/13/2015
  • Oral Relistor methylnaltrexone regulatory update

    Progenics Pharmaceuticals Inc. (NASDAQ:PGNX), Tarrytown, N.Y. Valeant Pharmaceuticals International Inc. (TSX:VRX; NYSE:VRX), Laval, Quebec Product: Oral Relistor methylnaltrexone (MOA-728) Business: Gastrointestinal …

    Published on 7/13/2015
  • Oral suspension Orfadin nitisinone regulatory update

    Swedish Orphan Biovitrum AB (SSE:SOBI), Stockholm, Sweden Syngenta AG (SIX:SYNN; NYSE:SYT), Basel, Switzerland Product: Oral suspension Orfadin nitisinone Business: Endocrine/Metabolic The European Commission approved …

    Published on 7/13/2015
  • Orkambi ivacaftor/lumacaftor regulatory update

    Vertex Pharmaceuticals Inc. (NASDAQ:VRTX), Boston, Mass. Product: Orkambi ivacaftor/lumacaftor Business: Pulmonary FDA approved an NDA for Orkambi ivacaftor/lumacaftor from Vertex to treat cystic fibrosis in patients …

    Published on 7/13/2015
  • OxyContin oxycodone regulatory update

    Purdue Pharma L.P., Stamford, Conn. Product: OxyContin oxycodone Business: Neurology Purdue withdrew an sNDA for a reformulation of OxyContin oxycodone extended-release tablets to manage moderate to severe pain. The …

    Published on 7/13/2015
  • Radicut edaravone regulatory update

    Mitsubishi Tanabe Pharma Corp. (Tokyo:4508), Osaka, Japan Product: Radicut edaravone (MCI-186) Business: Neurology Mitsubishi Tanabe said Japan approved a regulatory application to expand the label of Radicut edaravone …

    Published on 7/13/2015

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