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Chronological Index of : Regulatory

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  • Aclidinium bromide/formoterol fumarate regulatory update

    Almirall S.A. (Madrid:ALM), Barcelona, Spain Actavis plc (NYSE:ACT), Dublin, Ireland Kyorin Pharmaceutical Co. Ltd. (Tokyo:4569), Tokyo, Japan Product: Aclidinium bromide/formoterol fumarate (Duaklir Genuair, Brimica …

    Published on 9/29/2014
  • Aramchol arachidyl amino cholanoic acid regulatory update

    Galmed Pharmaceuticals Ltd. (NASDAQ:GLMD), Tel Aviv, Israel Product: Aramchol arachidyl amino cholanoic acid Business: Hepatic FDA granted Fast Track designation to aramchol to treat non-alcoholic steato-hepatitis (NASH…

    Published on 9/29/2014
  • 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 Japan's Ministry of Health, Labor and Welfare (MHLW) approved a regulatory …

    Published on 9/29/2014
  • AVI-7537 regulatory update

    BioCryst Pharmaceuticals Inc. (NASDAQ:BCRX), Durham, N.C. Fab'entech, Lyon, France Mapp Biopharmaceutical Inc., San Diego, Calif. MediVector Inc., Boston, Mass. Sarepta Therapeutics Inc. (NASDAQ:SRPT), Cambridge, Mass. …

    Published on 9/29/2014
  • 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 Amgen submitted a BLA to FDA to treat Philadelphia-…

    Published on 9/29/2014
  • Brexpiprazole regulatory update

    H. Lundbeck A/S (CSE:LUN), Copenhagen, Denmark Otsuka Pharmaceutical Co. Ltd., Tokyo, Japan Product: Brexpiprazole (OPC-34712) Business: Neurology FDA accepted for review an NDA from Lundbeck and Otsuka for …

    Published on 9/29/2014
  • CivaSheet regulatory update

    CivaTech Oncology Inc., Research Triangle Park, N.C. Product: CivaSheet Business: Cancer FDA granted 510(k) clearance to CivaTech Oncology's CivaSheet to treat selected localized tumors. The implantable planar …

    Published on 9/29/2014
  • Coaguchek XS regulatory update

    Roche (SIX:ROG; OTCQX:RHHBY), Basel, Switzerland Product: Coaguchek XS Business: Diagnostic The U.K.'s NICE issued final guidance for point-of-care coagulometers Coaguchek XS system from Roche and InRatio2 PT/INR …

    Published on 9/29/2014
  • Egranli balugrastim regulatory update

    Teva Pharmaceutical Industries Ltd. (NYSE:TEVA), Petah Tikva, Israel Product: Egranli balugrastim (formerly Neugranin) Business: Hematology EMA's CHMP recommended approval of Teva's Egranli balugrastim to treat …

    Published on 9/29/2014
  • Enclomiphene regulatory update

    Repros Therapeutics Inc. (NASDAQ:RPRX), The Woodlands, Texas Product: Enclomiphene (Androxal) Business: Endocrine/Metabolic Repros said the conclusions reached by an FDA advisory panel at a Sept. 17 meeting to discuss …

    Published on 9/29/2014
  • 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 Regeneron said Japan's …

    Published on 9/29/2014
  • Fluocinolone acetonide intravitreal implant regulatory update

    Alimera Sciences Inc. (NASDAQ:ALIM), Alpharetta, Ga. pSivida Corp. (NASDAQ:PSDV; ASX:PVA), Watertown, Mass. Specialised Therapeutics Australia Pty. Ltd., Melbourne, Australia Product: Fluocinolone acetonide intravitreal…

    Published on 9/29/2014
  • ForeCYTE Breast Aspirator regulatory update

    Atossa Genetics Inc. (NASDAQ:ATOS), Seattle, Wash. Product: ForeCYTE Breast Aspirator (formerly ForeCYTE Breast Health Test) Business: Diagnostic Atossa said FDA declined to approve the company's 510(k) application for …

    Published on 9/29/2014
  • HART-Trachea regulatory update

    Harvard Apparatus Regenerative Technology Inc. (NASDAQ:HART), Holliston, Mass. Product: HART-Trachea Business: Transplant FDA granted Orphan Drug designation to Harvard Apparatus' HART-Trachea to restore the structure …

    Published on 9/29/2014
  • Harvoni ledipasvir regulatory update

    Gilead Sciences Inc. (NASDAQ:GILD), Foster City, Calif. Product: Harvoni ledipasvir (GS-5885)/sofosbuvir (GS-7977) Business: Infectious EMA's CHMP recommended approval of the MAA for Harvoni ledipasvir/sofosbuvir from …

    Published on 9/29/2014
  • Humira adalimumab regulatory update

    AbbVie Inc. (NYSE:ABBV), Chicago, Ill. Eisai Co. Ltd. (Tokyo:4523), Tokyo, Japan Product: Humira adalimumab Business: Autoimmune The U.K.'s NICE issued draft guidance recommending against the use of 3 mAbs against tumor…

    Published on 9/29/2014
  • InRatio2 PT/INR Monitor regulatory update

    Alere Inc. (NYSE:ALR), Waltham, Mass. Product: InRatio2 PT/INR Monitor Business: Diagnostic The U.K.'s NICE issued final guidance for point-of-care coagulometers Coaguchek XS system from Roche (SIX:ROG; OTCQX:RHHBY, …

    Published on 9/29/2014
  • MEDI3902 regulatory update

    AstraZeneca plc (LSE:AZN; NYSE:AZN), London, U.K. Product: MEDI3902 Business: Infectious AstraZeneca's MedImmune LLC unit said FDA granted Fast Track designation to MEDI3902 to prevent nosocomial pneumonia caused by …

    Published on 9/29/2014
  • Moventig naloxegol regulatory update

    Nektar Therapeutics (NASDAQ:NKTR), San Francisco, Calif. AstraZeneca plc (LSE:AZN; NYSE:AZN), London, U.K. Product: Moventig naloxegol (Movantik) (formerly NKTR-118) Business: Gastrointestinal EMA's CHMP recommended …

    Published on 9/29/2014
  • Olaptesed pegol regulatory update

    Noxxon Pharma AG, Berlin, Germany Product: Olaptesed pegol (NOX-A12) Business: Cancer FDA granted Orphan Drug designation to olaptesed pegol from Noxxon to treat glioblastoma in conjunction with radiotherapy. The …

    Published on 9/29/2014
  • 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 Bristol-Myers said FDA accepted and …

    Published on 9/29/2014
  • Oral Lynovex cysteamine regulatory update

    NovaBiotics Ltd., Aberdeen, U.K. Product: Oral Lynovex cysteamine (NM001) Business: Pulmonary FDA granted Orphan Drug designation to NovaBiotics' Lynovex cysteamine to treat cystic fibrosis. NovaBiotics is developing …

    Published on 9/29/2014
  • Otezla apremilast regulatory update

    Celgene Corp. (NASDAQ:CELG), Summit, N.J. Product: Otezla apremilast (CC-10004) Business: Autoimmune FDA approved an sNDA from Celgene for Otezla apremilast to treat moderate to severe plaque psoriasis. Celgene said the…

    Published on 9/29/2014
  • Oxabact regulatory update

    OxThera AB, Uppsala, Sweden Product: Oxabact Business: Gastrointestinal The European Commission granted Orphan Drug designation to Oxabact from OxThera to treat short bowel syndrome (SBS). The capsule formulation of …

    Published on 9/29/2014
  • PBT2 regulatory update

    Prana Biotechnology Ltd. (ASX:PBT; NASDAQ:PRAN), Parkville, Australia Product: PBT2 Business: Neurology Prana said FDA granted Orphan Drug designation to PBT2 to treat Huntington's disease (HD). In February, the company…

    Published on 9/29/2014

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