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Chronological Index of : Regulatory

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  • Gardasil regulatory update

    Merck & Co. Inc. (NYSE:MRK), Kenilworth, N.J. Sanofi (Euronext:SAN; NYSE:SNY), Paris, France Product: Gardasil ( Silgard - EU) Business: Infectious EMAs Pharmacovigilance Risk Assessment Committee (PRAC) began a safety …

    Published on 8/17/2015
  • Humira adalimumab regulatory update

    AbbVie Inc. (NYSE:ABBV), Chicago, Ill. Eisai Co. Ltd. (Tokyo:4523), Tokyo, Japan Product: Humira adalimumab Business: Dermatology The European Commission approved an additional indication for Humira adalimumab to treat …

    Published on 8/17/2015
  • Illumigene HSV 1&2 molecular assay regulatory update

    Meridian Bioscience Inc. (NASDAQ:VIVO), Cincinnati, Ohio Product: Illumigene HSV 1&2 molecular assay Business: Diagnostic FDA granted 510(k) clearance to Meridians illumigene HSV 1&2 molecular assay to detect herpes …

    Published on 8/17/2015
  • Quanta Flash Ro52 regulatory update

    Werfen Group S.A., Barcelona, Spain Product: Quanta Flash Ro52 Business: Diagnostic FDA granted 510(k) clearance to Quanta Flash Ro52 from Werfens Inova Diagnostics Inc. subsidiary for use on Inovas Bio-Flash …

    Published on 8/17/2015
  • Quanta Flash Ro60 regulatory update

    Werfen Group S.A., Barcelona, Spain Product: Quanta Flash Ro60 Business: Diagnostic FDA granted 510(k) clearance to Quanta Flash Ro60 from Werfens Inova Diagnostics Inc. subsidiary for use on Inovas Bio-Flash …

    Published on 8/17/2015
  • Quanta Flash SSB regulatory update

    Werfen Group S.A., Barcelona, Spain Product: Quanta Flash SSB Business: Diagnostic FDA granted 510(k) clearance to Quanta Flash SSB from Werfens Inova Diagnostics Inc. subsidiary for use on Inovas Bio-Flash …

    Published on 8/17/2015
  • Remicade remicade infliximab regulatory update

    Mitsubishi Tanabe Pharma Corp. (Tokyo:4508), Osaka, Japan Johnson & Johnson (NYSE:JNJ), New Brunswick, N.J. Merck & Co. Inc. (NYSE:MRK), Kenilworth, N.J. Product: Remicade remicade infliximab (formerly TA-650) Business:…

    Published on 8/17/2015
  • Rintega rindopepimut regulatory update

    Celldex Therapeutics Inc. (NASDAQ:CLDX), Needham, Mass. Product: Rintega rindopepimut (CDX-110) (formerly PF-04948568) Business: Cancer Celldex said it does not expect to submit a BLA to FDA or regulatory application to…

    Published on 8/17/2015
  • TD-8954 regulatory update

    Theravance Biopharma Inc. (NASDAQ:TBPH), South San Francisco, Calif. Product: TD-8954 Business: Gastrointestinal FDA granted Fast Track designation to TD-8954 for short-term use with enteral feeding to achieve early …

    Published on 8/17/2015
  • Vitaros alprostadil regulatory update

    Apricus Biosciences Inc. (NASDAQ:APRI), San Diego, Calif. Product: Vitaros alprostadil Business: Genitourinary Apricus said Vitaros alprostadil was approved to treat erectile dysfunction (ED) in Austria, Cyprus, the …

    Published on 8/17/2015
  • Vocimagene amiretrorepvec/extended release flucytosine regulatory update

    Tocagen Inc., San Diego, Calif. Product: Vocimagene amiretrorepvec/extended release flucytosine (Toca 511/Toca FC) Business: Cancer FDA granted Fast Track designation to Tocagens Toca 511/Toca FC to treat recurrent high…

    Published on 8/17/2015
  • Zorblisa regulatory update

    Scioderm LLC, Raleigh, N.C. Product: Zorblisa (SD-101) Business: Dermatology Scioderm said it will begin submitting a rolling NDA to FDA this quarter for Zorblisa to treat epidermolysis bullosa. The company said it will…

    Published on 8/17/2015
  • Azedra regulatory update

    Progenics Pharmaceuticals Inc. (NASDAQ:PGNX), Tarrytown, N.Y. Product: Azedra (Ultratrace I-131-MIBG, Ultratrace iobenguane I 131) Business: Cancer FDA granted breakthrough therapy designation to Progenics Azedra to …

    Published on 8/10/2015
  • CollaRx gentamicin topical regulatory update

    Innocoll AG (NASDAQ:INNL), Athlone, Ireland Product: CollaRx gentamicin topical, Cogenzia Business: Infectious FDA granted Qualified Infectious Disease Product (QIDP) to Cogenzia from Innocoll as an adjunctive treatment…

    Published on 8/10/2015
  • Imbruvica ibrutinib regulatory update

    AbbVie Inc. (NYSE:ABBV), Chicago, Ill. Johnson & Johnson (NYSE:JNJ), New Brunswick, N.J. Product: Imbruvica ibrutinib (PCI-32765) Business: Cancer Health Canada granted conditional approval to Imbruvica ibrutinib from …

    Published on 8/10/2015
  • Levetiracetam regulatory update

    Aprecia Pharmaceuticals Co., Langhorne, Pa. Product: Levetiracetam (Spritam) Business: Neurology FDA approved an NDA from Aprecia for Spritam levetiracetam as an adjunct treatment of seizures in epileptics. Spritam is …

    Published on 8/10/2015
  • Naloxone nasal spray regulatory update

    Indivior plc (LSE:INDV), Richmond, Va. AntiOp Inc., Lexington, Ky. Product: Naloxone nasal spray Business: Neurology Indivior said FDA accepted and granted Priority Review to an NDA for naloxone nasal spray to treat …

    Published on 8/10/2015
  • 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 Ono submitted an application in …

    Published on 8/10/2015
  • Perampanel regulatory update

    Eisai Co. Ltd. (Tokyo:4523), Tokyo, Japan Product: Perampanel (Fycompa) (E2007) Business: Neurology Eisai submitted an NDA in Japan for perampanel as an adjunctive therapy for partial-onset and primary generalized tonic…

    Published on 8/10/2015
  • Perjeta pertuzumab regulatory update

    Genentech Inc., South San Francisco, Calif. Roche (SIX:ROG; OTCQX:RHHBY), Basel, Switzerland Product: Perjeta pertuzumab (R1273, RG1273) Business: Cancer Roche said that the European Commission approved an expanded …

    Published on 8/10/2015
  • Prevenar 13 regulatory update

    Pfizer Inc. (NYSE:PFE), New York, N.Y. Product: Prevenar 13 (13vPNC, PCV13) Business: Infectious Health Canada approved an expanded label for Prevnar 13 pneumococcal vaccine from Pfizer to include its use in people ages…

    Published on 8/10/2015
  • Rayaldee regulatory update

    Opko Health Inc. (NYSE:OPK; Tel Aviv:OPK), Miami, Fla. Product: Rayaldee (CTAP101) (formerly Rayaldy) Business: Endocrine/Metabolic FDA accepted for review an NDA from Opko for Rayaldee to treat and prevent secondary …

    Published on 8/10/2015
  • RTU bivalirudin regulatory update

    Eagle Pharmaceuticals Inc. (NASDAQ:EGRX), Woodcliff Lake, N.J. Product: RTU bivalirudin (EP-6101) Business: Cardiovascular FDA accepted for review an NDA from Eagle for anticoagulant RTU bivalirudin, a ready-to-use …

    Published on 8/10/2015
  • RVIII-SingleChain regulatory update

    CSL Ltd. (ASX:CSL), Melbourne, Australia Product: RVIII-SingleChain (CSL627) (formerly rFVIII) Business: Hematology FDA accepted for review a BLA from CSL for rVIII-SingleChain to treat hemophilia A. The product is …

    Published on 8/10/2015
  • Aerucin regulatory update

    Aridis Pharmaceuticals Inc., San Jose, Calif. Product: Aerucin Business: Infectious FDA granted Fast Track designation to Aridis Aerucin to treat hospital-acquired and ventilator-associated pneumonia caused by …

    Published on 8/3/2015

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