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Chronological Index of : Regulatory

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  • Ampligen rintatolimod regulatory update

    Hemispherx Biopharma Inc. (NYSE-M:HEB), Philadelphia, Pa. Product: Ampligen rintatolimod Business: Infectious The European Commission granted Orphan Drug designation to Ampligen rintatolimod from Hemispherx to treat …

    Published on 5/25/2015
  • ATIR regulatory update

    Kiadis Pharma B.V., Amsterdam, the Netherlands Product: ATIR Business: Transplant EMA classified Kiadis ATIR as an advanced therapy medicinal product (ATMP). ATIR is in Phase II testing to reduce transplant-related …

    Published on 5/25/2015
  • CD101 IV regulatory update

    Cidara Therapeutics Inc. (NASDAQ:CDTX), San Diego, Calif. Product: CD101 IV (formerly Biafungin, SP 3025) Business: Infectious FDA granted Qualified Infectious Disease Product (QIDP) and Fast Track designation to CD101 …

    Published on 5/25/2015
  • CG100 regulatory update

    Therabron Therapeutics Inc., Rockville, Md. Product: CG100 Business: Pulmonary The European Commission granted Orphan Drug designation to CG100 from Therabron to prevent bronchopulmonary dysplasia (BPD). The recombinant…

    Published on 5/25/2015
  • Daklinza daclatasvir regulatory update

    Bristol-Myers Squibb Co. (NYSE:BMY), New York, N.Y. Product: Daklinza daclatasvir (BMS-790052) Business: Infectious Bristol-Myers said it received an amended breakthrough therapy designation from FDA for daclatasvir …

    Published on 5/25/2015
  • Eteplirsen regulatory update

    Sarepta Therapeutics Inc. (NASDAQ:SRPT), Cambridge, Mass. Product: Eteplirsen (AVI-4658) Business: Musculoskeletal Sarepta began a rolling NDA submission for eteplirsen to treat Duchenne muscular dystrophy (DMD). The …

    Published on 5/25/2015
  • Evofosfamide regulatory update

    Threshold Pharmaceuticals Inc. (NASDAQ:THLD), South San Francisco, Calif. Merck KGaA (Xetra:MRK), Darmstadt, Germany Product: Evofosfamide (TH-302) Business: Cancer FDA granted Fast Track designation to evofosfamide …

    Published on 5/25/2015
  • FCX-007 regulatory update

    Fibrocell Science Inc. (NASDAQ:FCSC), Exton, Pa. Intrexon Corp. (NYSE:XON), Germantown, Md. Product: FCX-007 Business: Dermatology Fibrocell said FDA granted rare pediatric disease designation to FCX-007 to treat …

    Published on 5/25/2015
  • Humira adalimumab regulatory update

    AbbVie Inc. (NYSE:ABBV), Chicago, Ill. Eisai Co. Ltd. (Tokyo:4523), Tokyo, Japan Product: Humira adalimumab Business: Dermatology FDA granted Orphan Drug designation to Humira adalimumab from AbbVie to treat moderate to…

    Published on 5/25/2015
  • Invega Sustenna paliperidone palmitate regulatory update

    Johnson & Johnson (NYSE:JNJ), New Brunswick, N.J. Product: Invega Sustenna paliperidone palmitate ( Xeplion - EU) Business: Neurology FDA issued a complete response letter for an sNDA from Johnson & Johnsons Janssen …

    Published on 5/25/2015
  • Optune regulatory update

    Novocure Ltd., Isle of Jersey Product: Optune (NovoTTF-100A System, Optune)) Business: Cancer FDA accepted and granted Priority Review to a supplemental PMA from Novocure for Optune tumor treating fields (TTFields) …

    Published on 5/25/2015
  • 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), Whitehouse Station, N.J. Product: Remicade infliximab (formerly TA-650) Business: …

    Published on 5/25/2015
  • TRC105 regulatory update

    Tracon Pharmaceuticals Inc. (NASDAQ:TCON), San Diego, Calif. Product: TRC105 Business: Cancer FDA granted Fast Track designation to TRC105 from Tracon to treat advanced renal cell carcinoma (RCC) in combination with …

    Published on 5/25/2015
  • Treximet sumatriptan/naproxen regulatory update

    Pernix Therapeutics Holdings Inc. (NASDAQ:PTX), Morristown, N.J. Pozen Inc. (NASDAQ:POZN), Chapel Hill, N.C. GlaxoSmithKline plc (LSE:GSK; NYSE:GSK), London, U.K. Product: Treximet sumatriptan/naproxen Business: …

    Published on 5/25/2015
  • Avelox moxifloxacin regulatory update

    Bayer AG (Xetra:BAYN), Leverkusen, Germany Product: Avelox moxifloxacin (Actira, Octegra, Avalox) Business: Infectious FDA approved an sNDA from Bayer for Avelox moxifloxacin to treat and prevent plague. The agency …

    Published on 5/18/2015
  • Bosatria mepolizumab regulatory update

    GlaxoSmithKline plc (LSE:GSK; NYSE:GSK), London, U.K. Product: Bosatria mepolizumab (SB-240563) Business: Inflammation FDAs Pulmonary-Allergy Drugs Advisory Committee will meet June 11 to discuss a BLA from …

    Published on 5/18/2015
  • Cobiprostone regulatory update

    Sucampo Pharmaceuticals Inc. (NASDAQ:SCMP), Bethesda, Md. Product: Cobiprostone (SPI-8811) (formerly RU-8811) Business: Other FDA granted Fast Track designation to cobiprostone from Sucampo to treat and prevent oral …

    Published on 5/18/2015
  • Flibanserin regulatory update

    Sprout Pharmaceuticals Inc., Raleigh, N.C. Product: Flibanserin (formerly BIMT-17) Business: Genitourinary FDAs Bone, Reproductive and Urologic Drugs and Drug Safety and Risk Management advisory committees will meet on …

    Published on 5/18/2015
  • ND0612H regulatory update

    NeuroDerm Ltd. (NASDAQ:NDRM), Ness Ziona, Israel Product: ND0612H Business: Neurology FDA lifted a clinical hold on NeuroDerms ND0612H and ND0612L to treat Parkinsons disease. The company plans to begin U.S. clinical …

    Published on 5/18/2015
  • ND0612L regulatory update

    NeuroDerm Ltd. (NASDAQ:NDRM), Ness Ziona, Israel Product: ND0612L Business: Neurology FDA lifted a clinical hold on NeuroDerms ND0612H and ND0612L to treat Parkinsons disease. The company plans to begin U.S. clinical …

    Published on 5/18/2015
  • Orkambi ivacaftor/lumacaftor regulatory update

    Vertex Pharmaceuticals Inc. (NASDAQ:VRTX), Boston, Mass. Product: Orkambi ivacaftor/lumacaftor Business: Pulmonary FDAs Pulmonary-Allergy Drugs Advisory Committee voted 12-1 that available efficacy and safety data …

    Published on 5/18/2015
  • RE-024 regulatory update

    Retrophin Inc. (NASDAQ:RTRX), New York, N.Y. Product: RE-024 Business: Neurology FDA granted Orphan Drug designation to RE-024 from Retrophin to treat pantothenate kinase-associated neurodegeneration (PKAN). The product…

    Published on 5/18/2015
  • SRX-1177 regulatory update

    SolaranRx Inc., Albuquerque, N.M. Product: SRX-1177 Business: Cancer FDA granted Orphan Drug designation to SRX-1177 to treat stage IIB-IV malignant melanoma. SRX-1177 is in preclinical testing. The radiolabeled peptide…

    Published on 5/18/2015
  • Tysabri natalizumab regulatory update

    Biogen Inc. (NASDAQ:BIIB), Cambridge, Mass. Product: Tysabri natalizumab Business: Autoimmune EMAs Pharmacovigilance Risk Assessment Committee (PRAC) began its review to evaluate whether advice given to healthcare …

    Published on 5/18/2015
  • Zykadia ceritinib regulatory update

    Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland Product: Zykadia ceritinib (LDK378) Business: Cancer The European Commission approved Zykadia ceritinib from Novartis to treat advanced anaplastic lymphoma kinase (…

    Published on 5/18/2015

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