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Chronological Index of : Regulatory

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  • Aptima Zika Virus assay regulatory update

    Hologic Inc. (NASDAQ:HOLX), Bedford, Mass. Product: Aptima Zika Virus assay Business: Diagnostic FDA granted emergency use authorization (EUA) to Hologics Aptima Zika Virus assay for in vitro qualitative detection of …

    Published on 6/27/2016
  • Arzerra ofatumumab regulatory update

    Genmab A/S (CSE:GEN), Copenhagen, Denmark Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland Product: Arzerra ofatumumab (HuMax-CD20) Business: Cancer EMAs CHMP recommended against expanding the label of Arzerra …

    Published on 6/27/2016
  • Brigatinib regulatory update

    Ariad Pharmaceuticals Inc. (NASDAQ:ARIA), Cambridge, Mass. Product: Brigatinib (AP26113) Business: Cancer Ariad began submission of a rolling NDA to FDA for brigatinib to treat anaplastic lymphoma kinase (ALK)-positive …

    Published on 6/27/2016
  • Cetirizine regulatory update

    Nicox S.A. (Euronext:COX), Sophia Antipolis, France Product: Cetirizine (AC-170) Business: Inflammation FDA accepted and granted Priority Review to an NDA from Nicox for AC-170 to treat ocular itching associated with …

    Published on 6/27/2016
  • Edaravone regulatory update

    Mitsubishi Tanabe Pharma Corp. (Tokyo:4508), Osaka, Japan Product: Edaravone (Radicut) (MCI-186) Business: Neurology Mitsubishi submitted an NDA to FDA for edaravone to treat amyotrophic lateral sclerosis. The IV …

    Published on 6/27/2016
  • FluMist Quadrivalent regulatory update

    AstraZeneca plc (LSE:AZN; NYSE:AZN), London, U.K. Product: FluMist Quadrivalent (Fluenz Tetra) (MEDI-3250) Business: Infectious The U.S. CDCs Advisory Committee on Immunization Practices (ACIP) recommended against the …

    Published on 6/27/2016
  • Idylla Ebola Virus Triage Test regulatory update

    Biocartis Group N.V. (Euronext:BCART), Mechelen, Belgium Johnson & Johnson (NYSE:JNJ), New Brunswick, N.J. Product: Idylla Ebola Virus Triage Test Business: Diagnostic Biocartis said FDA granted emergency use …

    Published on 6/27/2016
  • Raxone idebenone regulatory update

    Santhera Pharmaceuticals Holding AG (SIX:SANN), Liestal, Switzerland Product: Raxone idebenone (SNT-MC17) Business: Musculoskeletal Santhera said EMA accepted for review a Type II variation application for Raxone …

    Published on 6/27/2016
  • Rayaldee calcifediol regulatory update

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

    Published on 6/27/2016
  • RealStar Zika Virus RT-PCR Kit U regulatory update

    altona Diagnostics GmbH, Hamburg, Germany Product: RealStar Zika Virus RT-PCR Kit U.S. Business: Diagnostic FDA granted emergency use authorization (EUA) to altonas RealStar Zika Virus RT-PCR Kit U.S for in vitro …

    Published on 6/27/2016
  • Trokendi XR topiramate regulatory update

    Supernus Pharmaceuticals Inc. (NASDAQ:SUPN), Rockville, Md. Product: Trokendi XR topiramate (formerly SPN-538) Business: Neurology Supernus said FDA asked the company to resubmit its proposed label for Trokendi XR …

    Published on 6/27/2016
  • Vaxchora regulatory update

    PaxVax Inc., Redwood City, Calif. Product: Vaxchora (PXVX0200) Business: Infectious The U.S. CDCs Advisory Committee on Immunization Practices (ACIP) recommended the use of PaxVaxs Vaxchora vaccine to prevent cholera …

    Published on 6/27/2016
  • Apadaz benzhydrocodone/acetaminophen regulatory update

    KemPharm Inc. (NASDAQ:KMPH), Coralville, Iowa Product: Apadaz benzhydrocodone/acetaminophen (KP201/APAP) Business: Neurology FDA issued a complete response letter to KemPharm for Apadaz benzhydrocodone/acetaminophen as …

    Published on 6/20/2016
  • APX001 regulatory update

    Amplyx Pharmaceuticals Inc., San Diego, Calif. Eisai Co. Ltd. (Tokyo:4523), Tokyo, Japan Product: APX001 Business: Infectious FDA granted Qualified Infectious Disease Product (QIDP) designation to APX001 from Amplyx to …

    Published on 6/20/2016
  • Arikayce amikacin regulatory update

    Insmed Inc. (NASDAQ:INSM), Monmouth Junction, N.J. Product: Arikayce amikacin (Arikace) (formerly SLIT amikacin) Business: Infectious Insmed withdrew an MAA from EMA for Arikayce to treat non-tuberculous mycobacterial (…

    Published on 6/20/2016
  • 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 The European …

    Published on 6/20/2016
  • Biosimilar adalimumab regulatory update

    Amgen Inc. (NASDAQ:AMGN), Thousand Oaks, Calif. Product: Biosimilar adalimumab (ABP 501) Business: Autoimmune FDAs Arthritis Advisory Committee will meet on July 12 to discuss a BLA from Amgen for ABP 501, a biosimilar …

    Published on 6/20/2016
  • CL-108 regulatory update

    Charleston Laboratories Inc., Jupiter, Fla. Daiichi Sankyo Co. Ltd. (Tokyo:4568), Tokyo, Japan Product: CL-108 Business: Neurology Charleston Labs and Daiichi Sankyo said FDA accepted for review an NDA for CL-108 to …

    Published on 6/20/2016
  • Deflazacort regulatory update

    Marathon Pharmaceuticals LLC, Northbrook, Ill. Product: Deflazacort (MP-104) Business: Musculoskeletal Marathon submitted an NDA to FDA for deflazacort to treat Duchenne muscular dystrophy (DMD). Deflazacort has Fast …

    Published on 6/20/2016
  • Glassia regulatory update

    Kamada Ltd. (Tel Aviv:KMDA; NASDAQ:KMDA), Ness Ziona, Israel Shire plc (LSE:SHP; NASDAQ:SHPG), Dublin, Ireland Product: Glassia (IV Alpha-1 Antitrypsin (AAT)) Business: Pulmonary Kamada and Shire said FDA approved an …

    Published on 6/20/2016
  • Taigexyn nemonoxacin regulatory update

    TaiGen Biopharmaceuticals Holdings Ltd. (TPEx:4157), Taipei, Taiwan Product: Taigexyn nemonoxacin (oral nemonoxacin) (TG-873870) Business: Infectious The China FDA approved TaiGens oral Taigexyn nemonoxacin, a non-…

    Published on 6/20/2016
  • Tivicay dolutegravir regulatory update

    ViiV Healthcare Ltd., Brentford, U.K. Product: Tivicay dolutegravir Business: Infectious FDA approved an sNDA from ViiV for 10 and 25 mg tablets of Tivicay dolutegravir to treat HIV-1 infection and expanded the label to…

    Published on 6/20/2016
  • Vaxchora regulatory update

    PaxVax Inc., Redwood City, Calif. Product: Vaxchora (PXVX0200) Business: Infectious FDA approved a BLA from PaxVax for Vaxchora to prevent cholera caused by Vibrio cholerae serogroup O1 in adults ages 18-64 traveling to…

    Published on 6/20/2016
  • Zinplava bezlotoxumab regulatory update

    Bristol-Myers Squibb Co. (NYSE:BMY), New York, N.Y. Merck & Co. Inc. (NYSE:MRK), Kenilworth, N.J. Product: Zinplava bezlotoxumab (MK-6072) (formerly MDX-1388, CDB-1) Business: Infectious FDAs Antimicrobial Drugs …

    Published on 6/20/2016
  • Biosimilar etanercept regulatory update

    Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland Product: Biosimilar etanercept (GP2015) Business: Autoimmune FDAs Arthritis Advisory Committee will meet on July 13 to discuss a BLA from Novartis Sandoz Inc. …

    Published on 6/13/2016

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