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Chronological Index of : Regulatory

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  • Akynzeo netupitant/palonosetron regulatory update

    Helsinn Healthcare S.A., Lugano, Switzerland Sinclair IS Pharma plc (LSE:SPH), London, U.K. Taiho Pharmaceutical Co. Ltd., Tokyo, Japan Product: Akynzeo netupitant/palonosetron (NEPA) (formerly Netu-palo-FDC) Business: …

    Published on 10/13/2014
  • AP26113 regulatory update

    Ariad Pharmaceuticals Inc. (NASDAQ:ARIA), Cambridge, Mass. Product: AP26113 Business: Cancer Ariad said FDA granted breakthrough therapy designation for AP26113 to treat anaplastic lymphoma kinase (ALK)-positive, …

    Published on 10/13/2014
  • Asunaprevir regulatory update

    Bristol-Myers Squibb Co. (NYSE:BMY), New York, N.Y. Product: Asunaprevir (Sunvepra) (BMS-650032) Business: Infectious Bristol-Myers said it has withdrawn its NDA for asunaprevir and will no longer pursue FDA approval of…

    Published on 10/13/2014
  • Avastin bevacizumab regulatory update

    Genentech Inc., South San Francisco, Calif. Chugai Pharmaceutical Co. Ltd. (Tokyo:4519), Tokyo, Japan Roche (SIX:ROG; OTCQX:RHHBY), Basel, Switzerland Product: Avastin bevacizumab (RG435) Business: Cancer EMA's CHMP …

    Published on 10/13/2014
  • Blinatumomab regulatory update

    Amgen Inc. (NASDAQ:AMGN), Thousand Oaks, Calif. Astellas Pharma Inc. (Tokyo:4503), Tokyo, Japan Product: Blinatumomab (AMG 103) (formerly MT103) Business: Cancer FDA accepted and granted Priority Review to a BLA for …

    Published on 10/13/2014
  • ColoMarker regulatory update

    EDP Biotech Corp., Knoxville, Tenn. Product: ColoMarker Business: Diagnostic EDP Biotech said it received CE Mark approval for its ColoMarker in vitro diagnostic to detect early stage colon cancer. The blood test …

    Published on 10/13/2014
  • 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 FDA approved an sBLA from …

    Published on 10/13/2014
  • Fomepizole regulatory update

    Endo International plc (NASDAQ:ENDP; TSX:ENL), Dublin, Ireland Takeda Pharmaceutical Co. Ltd. (Tokyo:4502), Osaka, Japan Product: Fomepizole (Antizol) Business: Other Takeda said Japan's Ministry of Health, Labor and …

    Published on 10/13/2014
  • Harvoni ledipasvir regulatory update

    Gilead Sciences Inc. (NASDAQ:GILD), Foster City, Calif. Product: Harvoni ledipasvir (GS-5885)/sofosbuvir (GS-7977) Business: Infectious FDA approved once-daily Harvoni ledipasvir/sofosbuvir from Gilead to treat chronic …

    Published on 10/13/2014
  • Hydrocodone bitartrate ER regulatory update

    Teva Pharmaceutical Industries Ltd. (NYSE:TEVA), Petah Tikva, Israel Product: Hydrocodone bitartrate ER (CEP-33237) Business: Neurology Teva said it began submission of a rolling NDA to FDA for hydrocodone bitartrate ER…

    Published on 10/13/2014
  • Intercept Blood System for platelets regulatory update

    Cerus Corp. (NASDAQ:CERS), Concord, Calif. Fresenius SE & Co. KGaA (Xetra:FRE; OTCQX:FSNUY), Bad Homburg, Germany Product: Intercept Blood System for platelets Business: Hematology Cerus said FDA accepted a clinical …

    Published on 10/13/2014
  • Interferon gamma-1b regulatory update

    Horizon Pharma plc (NASDAQ:HZNP), Dublin, Ireland Product: Interferon gamma-1b (Actimmune) Business: Neurology FDA granted Orphan Drug designation to Horizon's Actimmune interferon gamma-1b to treat Friedreich's ataxia.…

    Published on 10/13/2014
  • Kalydeco ivacaftor regulatory update

    Vertex Pharmaceuticals Inc. (NASDAQ:VRTX), Boston, Mass. Product: Kalydeco ivacaftor (VX-770) Business: Pulmonary Vertex submitted an sNDA to FDA for Kalydeco ivacaftor to treat cystic fibrosis in patients ages 2-5 …

    Published on 10/13/2014
  • Ketoconazole HRA regulatory update

    HRA Pharma S.A., Paris, France Product: Ketoconazole HRA Business: Other EMA's CHMP recommended approval of oral ketoconazole HRA to treat endogenous Cushing's syndrome in patients ages >12 years. HRA Pharma expects …

    Published on 10/13/2014
  • Lefamulin regulatory update

    Nabriva Therapeutics AG, Vienna, Austria Product: Lefamulin (BC-3781) Business: Infectious FDA granted Qualified Infections Disease Product (QIDP) and Fast Track designation to lefamulin to treat community-acquired …

    Published on 10/13/2014
  • Lixiana edoxaban regulatory update

    Daiichi Sankyo Co. Ltd. (Tokyo:4568), Tokyo, Japan Product: Lixiana edoxaban (Savaysa) (DU-176b) Business: Cardiovascular Daiichi Sankyo said Japan's Ministry of Health, Labor and Welfare (MHLW) approved Lixiana …

    Published on 10/13/2014
  • Lymphoseek tilmanocept regulatory update

    Hainan Sinotau Pharmaceutical Co. Ltd, Beijing, China Navidea Biopharmaceuticals Inc. (NYSE-M:NAVB), Dublin, Ohio Product: Lymphoseek tilmanocept Business: Diagnostic EMA's CHMP recommended approval of Navidea's …

    Published on 10/13/2014
  • Minivelle regulatory update

    Hisamitsu Pharmaceutical Co. Inc. (Tokyo:4530), Tosu, Japan Product: Minivelle Business: Musculoskeletal FDA approved an sNDA from Hisamitsu's Noven Pharmaceuticals Inc. subsidiary for Minivelle estradiol transdermal …

    Published on 10/13/2014
  • Neuroblastoma vaccine regulatory update

    MabVax Therapeutics Holdings Inc. (OTCQB:TELKD), San Diego, Calif. Product: Neuroblastoma vaccine Business: Cancer FDA granted Orphan Drug designation to MabVax's neuroblastoma vaccine to treat neuroblastoma. The …

    Published on 10/13/2014
  • NurOwn regulatory update

    BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), New York, N.Y. Product: NurOwn (formerly Neurotrophic Factor Cells) Business: Neurology BrainStorm said FDA granted Fast Track designation to NurOwn to treat amyotrophic …

    Published on 10/13/2014
  • Panobinostat regulatory update

    Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland Product: Panobinostat (LBH589) Business: Cancer FDA's Oncologic Drugs Advisory Committee will meet on Nov. 6 to discuss an NDA from Novartis for panobinostat, which …

    Published on 10/13/2014
  • Rizaport rizatriptan regulatory update

    IntelGenx Corp. (TSX-V:IGX; OTCQX:IGXT), Saint-Laurent, Quebec RedHill Biopharma Ltd. (Tel Aviv:RDHL; NASDAQ:RDHL), Ramat-Gan, Israel Product: Rizaport rizatriptan (RHB-103) Business: Neurology RedHill and IntelGenx …

    Published on 10/13/2014
  • Selincro nalmefene regulatory update

    Biotie Therapies Corp. (HSE:BTH1V), Turku, Finland H. Lundbeck A/S (CSE:LUN), Copenhagen, Denmark Otsuka Pharmaceutical Co. Ltd., Tokyo, Japan Product: Selincro nalmefene Business: Neurology The U.K.'s NICE issued a …

    Published on 10/13/2014
  • SHP465 triple-bead MAS regulatory update

    Shire plc (LSE:SHP; NASDAQ:SHPG), Dublin, Ireland Product: SHP465 triple-bead MAS (formerly SPD465) Business: Neurology FDA requested additional pediatric data from Shire to support resubmission of an NDA for SHP465 …

    Published on 10/13/2014
  • Stool DNA colorectal cancer screening assay regulatory update

    Exact Sciences Corp. (NASDAQ:EXAS), Madison, Wis. Product: Stool DNA colorectal cancer screening assay (Cologuard) Business: Diagnostic CMS proposed reimbursement of $502 for Cologuard a day after issuing a final …

    Published on 10/13/2014

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