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Chronological Index of : Regulatory

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  • Adempas riociguat regulatory update

    Bayer AG (Xetra:BAYN), Leverkusen, Germany Merck & Co. Inc. (NYSE:MRK), Whitehouse Station, N.J. Product: Adempas riociguat (BAY 63-2521) Business: Cardiovascular Bayer said Japan approved a regulatory application to …

    Published on 3/23/2015
  • Aricept donepezil regulatory update

    Eisai Co. Ltd. (Tokyo:4523), Tokyo, Japan Pfizer Inc. (NYSE:PFE), New York, N.Y. Product: Aricept donepezil Business: Neurology Eisai said the China Food and Drug Administration (CFDA) accepted for review an NDA to …

    Published on 3/23/2015
  • Arzerra ofatumumab regulatory update

    Genmab A/S (CSE:GEN; OTCBB:GMXAY), Copenhagen, Denmark Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland Product: Arzerra ofatumumab (HuMax-CD20) Business: Cancer The U.K.s NICE issued a final appraisal determination…

    Published on 3/23/2015
  • Breo Ellipta fluticasone furoate/vilanterol regulatory update

    Theravance Inc. (NASDAQ:THRX), South San Francisco, Calif. GlaxoSmithKline plc (LSE:GSK; NYSE:GSK), London, U.K. Product: Breo Ellipta fluticasone furoate/vilanterol (Relvar-EU) (Relvar/Breo) (GW685698/GW64244) (…

    Published on 3/23/2015
  • Cholbam cholic acid regulatory update

    Asklepion Pharmaceuticals LLC, Baltimore, Md. Product: Cholbam cholic acid (formerly Xebam) Business: Gastrointestinal FDA approved an NDA for Cholbam cholic acid from Asklepion to treat bile acid synthesis disorders …

    Published on 3/23/2015
  • Entyvio vedolizumab regulatory update

    Takeda Pharmaceutical Co. Ltd. (Tokyo:4502), Osaka, Japan Product: Entyvio vedolizumab (MLN0002) Business: Autoimmune The U.K.s NICE issued a final appraisal determination (FAD) recommending Entyvio vedolizumab from …

    Published on 3/23/2015
  • 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 Bayer submitted a regulatory …

    Published on 3/23/2015
  • Gazyva obinutuzumab regulatory update

    Biogen Idec Inc. (NASDAQ:BIIB), Cambridge, 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 3/23/2015
  • Idarucizumab regulatory update

    Boehringer Ingelheim GmbH, Ingelheim, Germany Product: Idarucizumab (dabigatran antidote) (BI 655075) Business: Hematology Boehringer submitted regulatory applications to EMA and Health Canada seeking accelerated …

    Published on 3/23/2015
  • Lifitegrast regulatory update

    Shire plc (LSE:SHP; NASDAQ:SHPG), Dublin, Ireland Product: Lifitegrast (SHP606, SAR 1118) Business: Ophthalmic Shire submitted an NDA to FDA for lifitegrast to treat signs and symptoms of dry eye disease in adults. …

    Published on 3/23/2015
  • Lisa Tracker kits for trastuzumab regulatory update

    Theradiag (Euronext:ALTER), Marne La Vallee, France Product: Lisa Tracker kits for trastuzumab Business: Diagnostic Theradiag received CE Mark approval for its Lisa Tracker kits to monitor treatment with cancer drug …

    Published on 3/23/2015
  • Opdivo nivolumab regulatory update

    Ono Pharmaceutical Co. Ltd. (Tokyo:4528), Osaka, Japan Bristol-Myers Squibb Co. (NYSE:BMY), New York, N.Y. Product: Opdivo nivolumab (ONO-4538, MDX-1106, BMS-936558) Business: Cancer FDA approved an sBLA from Bristol-…

    Published on 3/23/2015
  • Sirolimus regulatory update

    Santen Pharmaceutical Co. Ltd. (Tokyo:4536), Osaka, Japan Product: Sirolimus (DE-109) Business: Ophthalmic Santen said EMA accepted for review an MAA for intravitreal sirolimus to treat non-infectious uveitis of the …

    Published on 3/23/2015
  • SoluMatrix meloxicam regulatory update

    Iroko Pharmaceuticals LLC, Philadelphia, Pa. Product: SoluMatrix meloxicam (IP 045) Business: Autoimmune FDA accepted for review an NDA for Irokos SoluMatrix meloxicam to treat osteoarthritis pain. Iroko declined to …

    Published on 3/23/2015
  • Stelara ustekinumab regulatory update

    Bristol-Myers Squibb Co. (NYSE:BMY), New York, N.Y. Johnson & Johnson (NYSE:JNJ), New Brunswick, N.J. Product: Stelara ustekinumab (CNTO 1275) Business: Autoimmune The U.K.s NICE issued a final appraisal determination (…

    Published on 3/23/2015
  • Uptravi selexipag regulatory update

    Actelion Ltd. (SIX:ATLN), Allschwil, Switzerland Nippon Shinyaku Co. Ltd. (Tokyo:4516), Kyoto, Japan Product: Uptravi selexipag (NS-304, ACT-293987) Business: Cardiovascular Actelion said FDA accepted for review an NDA …

    Published on 3/23/2015
  • Xiaflex collagenase clostridium histolyticum regulatory update

    BioSpecifics Technologies Corp. (NASDAQ:BSTC), Lynbrook, N.Y. Endo International plc (NASDAQ:ENDP; TSX:ENL), Dublin, Ireland Swedish Orphan Biovitrum AB (SSE:SOBI), Stockholm, Sweden Asahi Kasei Pharma Corp., Tokyo, …

    Published on 3/23/2015
  • 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 The European Commission approved an expanded label for Abraxane nab-…

    Published on 3/16/2015
  • Banzel rufinamide regulatory update

    Eisai Co. Ltd.(Tokyo:4523), Tokyo, Japan Novartis AG(NYSE:NVS; SIX:NOVN), Basel, Switzerland Product: Banzel rufinamide (Inovelon) (SYN-111) Business: Neurology FDA approved an sNDA from Eisai for Banzel rufinamide as …

    Published on 3/16/2015
  • Belbuca buprenorphine buccal film regulatory update

    BioDelivery Sciences International Inc.(NASDAQ:BDSI), Raleigh, N.C. Endo International plc(NASDAQ:ENDP; TSX:ENL), Dublin, Ireland Product: Belbuca buprenorphine buccal film (BEMA Buprenorphine) (EN3409) (formerly BEMA …

    Published on 3/16/2015
  • Beteflam Patch regulatory update

    Institut Biochimique S.A., Lugano, Switzerland Product: Beteflam Patch (Betesil Patch) Business: Dermatology Health Canada accepted for review an NDS for Beteflam Patch from Cipher Pharmaceuticals Inc. (TSX:DND; NASDAQ:…

    Published on 3/16/2015
  • Cingal regulatory update

    Anika Therapeutics Inc.(NASDAQ:ANIK), Bedford, Mass. Product: Cingal Business: Autoimmune Anika submitted a PMA in the U.S. for Cingal to treat osteoarthritis (OA) of the knee. Anika also submitted an application for CE…

    Published on 3/16/2015
  • Cresemba isavuconazonium regulatory update

    Basilea Pharmaceutica AG(SIX:BSLN), Basel, Switzerland Astellas Pharma Inc.(Tokyo:4503), Tokyo, Japan Product: Cresemba isavuconazonium, isavuconazole (BAL8557) Business: Infectious FDA approved an NDA from Astellas for…

    Published on 3/16/2015
  • Deoxycholic acid regulatory update

    Kythera Biopharmaceuticals Inc.(NASDAQ:KYTH), Calabasas, Calif. Product: Deoxycholic acid (ATX-101) Business: Other FDAs Dermatologic and Ophthalmic Drugs Advisory Committee voted 17-0 to recommend approval of ATX-101 …

    Published on 3/16/2015
  • Grastofil filgrastim regulatory update

    Apotex Inc., Toronto, Ontario Stada Arzneimittel AG(Xetra:SAZ), Bad Vilbel, Germany Product: Grastofil filgrastim Business: Hematology FDA accepted for review a BLA from Apotex for Grastofil, a biosimilar of neutropenia…

    Published on 3/16/2015

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