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Chronological Index of : Regulatory

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  • Sylvant siltuximab regulatory update

    Johnson & Johnson (NYSE:JNJ), New Brunswick, N.J. Product: Sylvant siltuximab (CNTO 328) Business: Cancer FDA approved a BLA for Sylvant siltuximab from Johnson & Johnson's Janssen Biotech Inc. unit to treat …

    Published on 4/28/2014
  • Tybost cobicistat regulatory update

    Gilead Sciences Inc. (NASDAQ:GILD), Foster City, Calif. Japan Tobacco Inc. (Tokyo:2914), Tokyo, Japan Product: Tybost cobicistat (GS-9350) (formerly GS 9350) Business: Infectious FDA accepted for review 2 resubmitted …

    Published on 4/28/2014
  • Velcade bortezomib regulatory update

    Takeda Pharmaceutical Co. Ltd. (Tokyo:4502), Osaka, Japan Johnson & Johnson (NYSE:JNJ), New Brunswick, N.J. Product: Velcade bortezomib Business: Cancer The U.K.'s NICE issued final guidance recommending the use of …

    Published on 4/28/2014
  • Vitekta elvitegravir regulatory update

    Gilead Sciences Inc. (NASDAQ:GILD), Foster City, Calif. Japan Tobacco Inc. (Tokyo:2914), Tokyo, Japan Product: Vitekta elvitegravir (GS 9137) Business: Infectious FDA accepted for review 2 resubmitted NDAs from Gilead …

    Published on 4/28/2014
  • Abraxane nab-paclitaxel regulatory update

    Celgene Corp. (NASDAQ:CELG), Summit, N.J. Taiho Pharmaceutical Co. Ltd., Tokyo, Japan Product: Abraxane nab-paclitaxel (ABI-007) Business: Cancer Specialised Therapeutics Australia Pty. Ltd. (Melbourne, Australia) said …

    Published on 3/24/2014
  • Alprolix rFIXFc regulatory update

    Biogen Idec Inc. (NASDAQ:BIIB), Weston, Mass. Swedish Orphan Biovitrum AB (SSE:SOBI), Stockholm, Sweden Product: Alprolix rFIXFc, Long Acting rFactor lX Business: Hematology Health Canada approved Alprolix rFIXFc from …

    Published on 3/24/2014
  • Aubagio teriflunomide regulatory update

    Sanofi (Euronext:SAN; NYSE:SNY), Paris, France Product: Aubagio teriflunomide Business: Autoimmune Germany's Federal Joint Committee (G-BA) said in a final benefit assessment that Aubagio teriflunomide from the Genzyme …

    Published on 3/24/2014
  • Eliquis apixaban regulatory update

    Bristol-Myers Squibb Co. (NYSE:BMY), New York, N.Y. Pfizer Inc. (NYSE:PFE), New York, N.Y. Product: Eliquis apixaban (BMS-562247-01) Business: Cardiovascular FDA approved an sNDA for Eliquis apixaban for the prophylaxis…

    Published on 3/24/2014
  • Entyvio vedolizumab regulatory update

    Takeda Pharmaceutical Co. Ltd. (Tokyo:4502), Osaka, Japan Product: Entyvio vedolizumab (MLN0002) Business: Autoimmune EMA's CHMP recommended approval of an MAA for Entyvio vedolizumab from Takeda to treat moderately to …

    Published on 3/24/2014
  • EpiFix regulatory update

    MiMedx Group Inc. (NASDAQ:MDXG), Marietta, Ga. Product: EpiFix Business: Dermatology MiMedx said it received reimbursement coverage from Medicare contractor First Coast Service Options Inc. for the company's EpiFix …

    Published on 3/24/2014
  • 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 Germany's Federal Joint …

    Published on 3/24/2014
  • Folcepri etarfolatide regulatory update

    Endocyte Inc. (NASDAQ:ECYT), West Lafayette, Ind. Product: Folcepri etarfolatide (EC20) Business: Diagnostic EMA's CHMP issued a positive opinion recommending conditional approval of Folcepri etarfolatide, a companion …

    Published on 3/24/2014
  • Gilotrif afatinib regulatory update

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

    Published on 3/24/2014
  • Hemangeol regulatory update

    Laboratoires Pierre Fabre S.A., Castres, France Maruho Co. Ltd., Osaka, Japan Product: Hemangeol (Hemangiol - EU) propranolol Business: Cancer FDA approved an NDA from Pierre Fabre for Hemangeol propranolol to treat …

    Published on 3/24/2014
  • Impavido miltefosine regulatory update

    Knight Therapeutics Inc. (TSX-V:GUD), Westmount, Quebec Product: Impavido miltefosine Business: Infectious FDA approved an NDA for Impavido miltefosine from Knight Therapeutics to treat cutaneous, mucosal and visceral …

    Published on 3/24/2014
  • 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 EMA's CHMP backed approval of Jardiance …

    Published on 3/24/2014
  • Jetrea ocriplasmin regulatory update

    ThromboGenics N.V. (Euronext:THR), Leuven, Belgium Product: Jetrea ocriplasmin (formerly Microplasmin) Business: Ophthalmic ThromboGenics said Swissmedic approved Jetrea ocriplasmin to treat vitreomacular traction (VMT…

    Published on 3/24/2014
  • Liquid lubiprostone regulatory update

    Sucampo Pharmaceuticals Inc. (NASDAQ:SCMP), Bethesda, Md. Product: Liquid lubiprostone Business: Gastrointestinal Sucampo and Takeda Pharmaceutical Co. Ltd. (Tokyo:4502, Osaka, Japan) said the partners will not submit …

    Published on 3/24/2014
  • Lojuxta lomitapide regulatory update

    Aegerion Pharmaceuticals Inc. (NASDAQ:AEGR), Cambridge, Mass. Product: Lojuxta lomitapide (Juxtapid) (AEGR-733) (formerly BMS-201038) Business: Endocrine/Metabolic Germany's Federal Joint Committee (G-BA) said in a …

    Published on 3/24/2014
  • Lymphoseek tilmanocept regulatory update

    Navidea Biopharmaceuticals Inc. (NYSE-M:NAVB), Dublin, Ohio Product: Lymphoseek tilmanocept Business: Diagnostic Navidea said it believes EMA's CHMP found the safety and efficacy data submitted in a MAA for Lymphoseek …

    Published on 3/24/2014
  • masitinib regulatory update

    AB Science S.A. (Euronext:AB), Paris, France Product: masitinib (Masican) (AB1010) Business: Cancer EMA's CHMP issued a negative opinion again recommending against conditional approval of masitinib from AB Science for …

    Published on 3/24/2014
  • MecA XpressFISH test regulatory update

    AdvanDx Inc., Woburn, Mass. Product: MecA XpressFISH test Business: Diagnostic AdvanDx submitted a 510(k) application to FDA for its mecA XpressFISH test to rapidly detect methicillin-resistant Staphylococcus aureus (…

    Published on 3/24/2014
  • Methylene Blue Methylthioninium chloride regulatory update

    Provepharm S.A.S., Marseille, France Daiichi Sankyo Co. Ltd. (Tokyo:4568), Tokyo, Japan Product: Methylene Blue Methylthioninium chloride (Proveblue) Business: Hematology Daiichi Sankyo submitted an NDA to Japan's …

    Published on 3/24/2014
  • MnB rLP2086 regulatory update

    Pfizer Inc. (NYSE:PFE), New York, N.Y. Product: MnB rLP2086, Meningococcal B vaccine (rLP2086, PF-5212366, PF-05212366) Business: Infectious Pfizer said FDA granted breakthrough therapy designation for bivalent rLP2086 …

    Published on 3/24/2014
  • Neocepri IV folic acid regulatory update

    Endocyte Inc. (NASDAQ:ECYT), West Lafayette, Ind. Product: Neocepri IV folic acid Business: Diagnostic EMA's CHMP issued a positive opinion recommending conditional approval of Neocepri IV folic acid, a companion …

    Published on 3/24/2014

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