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Chronological Index of : Regulatory

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  • Andexanet alfa regulatory update

    Portola Pharmaceuticals Inc. (NASDAQ:PTLA), South San Francisco, Calif. Product: Andexanet alfa (AndexXa) (PRT4445, PRT064445) Business: Hematology FDA issued a complete response letter to Portola for a BLA for AndexXa …

    Published on 8/22/2016
  • Autologous T cell therapy against CD19 regulatory update

    Kite Pharma Inc. (NASDAQ:KITE), Los Angeles, Calif. Product: Autologous T cell therapy against CD19 (KTE-C19) Business: Cancer EMA granted PRIority MEdicines (PRIME) designation to KTE-C19 from Kite to treat refractory …

    Published on 8/22/2016
  • Cinqaero reslizumab regulatory update

    Teva Pharmaceutical Industries Ltd. (NYSE:TEVA), Petah Tikva, Israel Product: Cinqaero reslizumab (Cinqair) Business: Inflammation The European Commission approved Cinqaero reslizumab from Teva as an add-on therapy for …

    Published on 8/22/2016
  • Darzalex daratumumab regulatory update

    Genmab A/S (CSE:GEN), Copenhagen, Denmark Johnson & Johnson (NYSE:JNJ), New Brunswick, N.J. Product: Darzalex daratumumab (HuMax-CD38) Business: Cancer Johnson & Johnsons Janssen Biotech Inc. unit submitted an sBLA to …

    Published on 8/22/2016
  • Esketamine regulatory update

    Johnson & Johnson (NYSE:JNJ), New Brunswick, N.J. Product: Esketamine Business: Neurology Johnson & Johnsons Janssen Research & Development LLC unit said FDA granted breakthrough drug designation to esketamine to treat …

    Published on 8/22/2016
  • Factor VIII drugs regulatory update

    Biogen Inc. (NASDAQ:BIIB), Cambridge, Mass. CSL Ltd. (ASX:CSL), Melbourne, Australia Octapharma AG, Lachen, Switzerland Swedish Orphan Biovitrum AB (SSE:SOBI), Stockholm, Sweden Baxalta Inc. (NYSE:BXLT), Deerfield, Ill.…

    Published on 8/22/2016
  • Factor VIII drugs regulatory update

    Biogen Inc. (NASDAQ:BIIB), Cambridge, Mass. CSL Ltd. (ASX:CSL), Melbourne, Australia Octapharma AG, Lachen, Switzerland Swedish Orphan Biovitrum AB (SSE:SOBI), Stockholm, Sweden Baxalta Inc. (NYSE:BXLT), Deerfield, Ill.…

    Published on 8/22/2016
  • Fluoroquinolones regulatory update

    Food and Drug Administration (FDA), Silver Spring, Md. Product: Fluoroquinolones Business: Infectious FDA approved safety labeling changes for oral and injectable fluoroquinolone antibiotics. The new labeling recommends…

    Published on 8/22/2016
  • Fluoroquinolones regulatory update

    Food and Drug Administration (FDA), Silver Spring, Md. Product: Fluoroquinolones Business: Infectious FDA approved safety labeling changes for oral and injectable fluoroquinolone antibiotics. The new labeling recommends…

    Published on 8/22/2016
  • Forxiga dapagliflozin regulatory update

    AstraZeneca plc (LSE:AZN; NYSE:AZN), London, U.K. Product: Forxiga dapagliflozin Business: Endocrine/Metabolic EMAs Pharmacovigilance Risk Assessment Committee (PRAC) extended its safety review of Type II diabetes drug …

    Published on 8/22/2016
  • FoundationOne regulatory update

    Foundation Medicine Inc. (NASDAQ:FMI), Cambridge, Mass. Product: FoundationOne Business: Diagnostic FDA and the Centers for Medicare and Medicaid Services (CMS) accepted Foundations FoundationOne comprehensive genomic …

    Published on 8/22/2016
  • Heplisav-B regulatory update

    Dynavax Technologies Corp. (NASDAQ:DVAX), Berkeley, Calif. Product: Heplisav-B (formerly V270) Business: Infectious FDAs Vaccines and Related Biological Products Advisory Committee will meet on Nov. 16 to discuss a BLA …

    Published on 8/22/2016
  • 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 EMAs Pharmacovigilance Risk Assessment Committee (…

    Published on 8/22/2016
  • Oxymorphone regulatory update

    Endo International plc (NASDAQ:ENDP; TSX:ENL), Dublin, Ireland Gruenenthal Group, Aachen, Germany Product: Oxymorphone (Crush-resistant Opana ER) Business: Neurology Endo said it will withdraw an sNDA seeking to add …

    Published on 8/22/2016
  • Solana Trichomoniasis assay regulatory update

    Quidel Corp. (NASDAQ:QDEL), San Diego, Calif. Product: Solana Trichomoniasis assay Business: Diagnostic FDA granted 510(k) clearance for Quidels Solana Trichomoniasis assay to detect trichomoniasis nucleic acids from …

    Published on 8/22/2016
  • Aristada aripiprazole lauroxil regulatory update

    Alkermes plc (NASDAQ:ALKS), Dublin, Ireland Product: Aristada aripiprazole lauroxil (ALKS 9070) Business: Neurology Alkermes submitted an sNDA to FDA for a 2-month dosing interval of Aristada aripiprazole lauroxil to …

    Published on 8/15/2016
  • Biosimilar pegfilgrastim regulatory update

    Coherus BioSciences Inc. (NASDAQ:CHRS), Redwood City, Calif. Product: Biosimilar pegfilgrastim (CHS-1701) Business: Hematology Coherus submitted a BLA to FDA for CHS-1701, a biosimilar of neutropenia drug Neulasta …

    Published on 8/15/2016
  • Deflazacort regulatory update

    Marathon Pharmaceuticals LLC, Northbrook, Ill. Product: Deflazacort (MP-104) Business: Musculoskeletal FDA accepted and granted Priority Review to NDAs from Marathon for deflazacort tablets and oral suspension to treat …

    Published on 8/15/2016
  • Dextenza sustained-release dexamethasone regulatory update

    Ocular Therapeutix Inc. (NASDAQ:OCUL), Bedford, Mass. Product: Dextenza sustained-release dexamethasone (OTX-DP) Business: Neurology Ocular said FDA notified the company that its corrective actions appear to address all…

    Published on 8/15/2016
  • DPP Zika IgM/IgG Assay regulatory update

    Chembio Diagnostics Inc. (NASDAQ:CEMI), Medford, N.Y. Product: DPP Zika IgM/IgG Assay Business: Diagnostic Chembio received CE Mark approval for DPP Zika IgM/IgG Assay to diagnose Zika virus infection by detecting …

    Published on 8/15/2016
  • Halaven eribulin mesylate regulatory update

    Eisai Co. Ltd. (Tokyo:4523), Tokyo, Japan Product: Halaven eribulin mesylate (E7389) Business: Cancer China Food and Drug Administration (CFDA) accepted for review an NDA from Eisai for Halaven to treat locally advanced…

    Published on 8/15/2016
  • Keytruda pembrolizumab regulatory update

    Merck & Co. Inc. (NYSE:MRK), Kenilworth, N.J. Product: Keytruda pembrolizumab (MK-3475) Business: Cancer FDA granted accelerated approval to an sBLA from Merck for Keytruda pembrolizumab to treat recurrent or metastatic…

    Published on 8/15/2016
  • MCB3837 regulatory update

    Biovertis AG, Vienna, Austria Product: MCB3837 Business: Infectious FDA granted Qualified Infectious Disease Product (QIDP) and Fast Track designations to MCB3837 from Biovertis Morphochem AG subsidiary to treat …

    Published on 8/15/2016
  • Orencia abatacept regulatory update

    Bristol-Myers Squibb Co. (NYSE:BMY), New York, N.Y. Product: Orencia abatacept (ONO-4164IV) Business: Autoimmune EMAs CHMP recommended expanding the label of Bristol-Myers Squibbs Orencia abatacept to include its use in…

    Published on 8/15/2016
  • Paliperidone palmitate regulatory update

    Alkermes plc (NASDAQ:ALKS), Dublin, Ireland Johnson & Johnson (NYSE:JNJ), New Brunswick, N.J. Product: Paliperidone palmitate (Trevicta, Invega Trinza) Business: Neurology The European Commission approved an MAA from …

    Published on 8/15/2016

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