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Chronological Index of : Regulatory

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  • Auryxia regulatory update

    Keryx Biopharmaceuticals Inc. (NASDAQ:KERX), New York, N.Y. Panion & BF Biotech Inc. (Taiwan:1760), Taipei, Taiwan Product: Auryxia ( Fexeric - EU, Riona) ferric citrate (KRX-0502, JTT-751) Business: Endocrine/Metabolic…

    Published on 8/24/2015
  • Brentuximab vedotin regulatory update

    Seattle Genetics Inc. (NASDAQ:SGEN), Bothell, Wash. Takeda Pharmaceutical Co. Ltd. (Tokyo:4502), Osaka, Japan Product: Brentuximab vedotin (Adcetris) (SGN-35) Business: Cancer FDA approved an sBLA from Seattle Genetics …

    Published on 8/24/2015
  • Dinutuximab regulatory update

    United Therapeutics Corp. (NASDAQ:UTHR), Silver Spring, Md. Product: Dinutuximab (Unituxin) (formerly Ch14.18) Business: Cancer The European Commission approved Unituxin dinutuximab from United Therapeutics to treat …

    Published on 8/24/2015
  • Empliciti elotuzumab regulatory update

    AbbVie Inc. (NYSE:ABBV), Chicago, Ill. Bristol-Myers Squibb Co. (NYSE:BMY), New York, N.Y. Product: Empliciti elotuzumab (HuLuc63, BMS-901608) Business: Cancer AbbVie and Bristol-Myers Squibb said EMA accepted and …

    Published on 8/24/2015
  • Eteplirsen regulatory update

    Sarepta Therapeutics Inc. (NASDAQ:SRPT), Cambridge, Mass. Product: Eteplirsen (AVI-4658) Business: Musculoskeletal Sarepta said FDA granted rare pediatric disease designation to eteplirsen to treat patients with …

    Published on 8/24/2015
  • Flibanserin regulatory update

    Sprout Pharmaceuticals Inc., Raleigh, N.C. Product: Flibanserin (Addyi) (formerly BIMT-17) Business: Genitourinary FDA approved an NDA from Sprout for Addyi flibanserin to treat acquired, generalized hypoactive sexual …

    Published on 8/24/2015
  • Intuniv guanfacine extended release regulatory update

    Shire plc (LSE:SHP; NASDAQ:SHPG), Dublin, Ireland Product: Intuniv guanfacine extended release (S-877503) Business: Neurology EMAs CHMP recommended approval of once-daily Intuniv guanfacine extended release from Shire …

    Published on 8/24/2015
  • IV cannabidiol regulatory update

    GW Pharmaceuticals plc (LSE:GWP; NASDAQ:GWPH), Salisbury, U.K. Product: IV cannabidiol (CBD) (IV GWP42003) Business: Neurology FDA granted Fast Track designation and EMA granted Orphan Drug designation to IV cannabidiol…

    Published on 8/24/2015
  • Ixazomib regulatory update

    Takeda Pharmaceutical Co. Ltd. (Tokyo:4502), Osaka, Japan Product: Ixazomib (MLN9708) Business: Cancer EMA accepted for review an MAA from Takeda to treat relapsed and/or refractory multiple myeloma (MM). Last month, …

    Published on 8/24/2015
  • Montelukast sodium regulatory update

    Kyorin Pharmaceutical Co. Ltd. (Tokyo:4569), Tokyo, Japan Merck & Co. Inc. (NYSE:MRK), Kenilworth, N.J. Product: Montelukast sodium (Kipres OD Tablets) Business: Inflammation Kyorin said Japan approved Kipres OD Tablets…

    Published on 8/24/2015
  • Mycapssa octreotide regulatory update

    Chiasma Inc. (NASDAQ:CHMA), Jerusalem, Israel Product: Mycapssa octreotide (RG3806) (formerly Octreolin) Business: Endocrine/Metabolic FDA accepted for review an NDA from Chiasma for Mycapssa octreotide for maintenance …

    Published on 8/24/2015
  • Oral solithromycin regulatory update

    Cempra Inc. (NASDAQ:CEMP), Chapel Hill, N.C. Merck & Co. Inc. (NYSE:MRK), Kenilworth, N.J. Product: Oral solithromycin (CEM-101) (formerly OPT-1068) Business: Infectious FDA granted Fast Track designation to IV and oral…

    Published on 8/24/2015
  • Procysbi cysteamine bitartrate delayed-release capsules regulatory update

    Raptor Pharmaceutical Corp. (NASDAQ:RPTP), Novato, Calif. Product: Procysbi cysteamine bitartrate delayed-release capsules (RP103) Business: Renal FDA approved an sNDA from Raptor for Procysbi cysteamine bitartrate …

    Published on 8/24/2015
  • Resunab regulatory update

    Corbus Pharmaceuticals Holdings Inc. (NASDAQ:CRBP), Norwood, Mass. Product: Resunab (JBT-101) Business: Autoimmune FDA granted Fast Track designation to Resunab from Corbus to treat systemic sclerosis. The company plans…

    Published on 8/24/2015
  • Rociletinib regulatory update

    Celgene Corp. (NASDAQ:CELG), Summit, N.J. Clovis Oncology Inc. (NASDAQ:CLVS), Boulder, Colo. Product: Rociletinib (AVL-301) (formerly CO-1686) Business: Cancer Clovis completed submission of a rolling NDA to FDA and …

    Published on 8/24/2015
  • Staphylococcus lysin regulatory update

    ContraFect Corp. (NASDAQ:CFRX), Yonkers, N.Y. Product: Staphylococcus lysin (CF-301) Business: Infectious FDA granted Fast Track designation to ContraFects CF-301 to treat Staphylococcus aureus bloodstream infections, …

    Published on 8/24/2015
  • Accelerate ID/AST Blood Culture Assay regulatory update

    Accelerate Diagnostics Inc. (NASDAQ:AXDX), Tucson, Ariz. Product: Accelerate ID/AST Blood Culture Assay Business: Diagnostic Accelerate received CE Mark approval for ID/AST Blood Culture Assay for use on the Accelerate …

    Published on 8/17/2015
  • Aggrastat tirofiban regulatory update

    Cardiome Pharma Corp. (TSX:COM; NASDAQ:CRME), Vancouver, B.C. Merck & Co. Inc. (NYSE:MRK), Kenilworth, N.J. Product: Aggrastat tirofiban Business: Cardiovascular Cardiome submitted an sNDS to Health Canada for Aggrastat…

    Published on 8/17/2015
  • Alere i Strep A test regulatory update

    Alere Inc. (NYSE:ALR), Waltham, Mass. Product: Alere i Strep A test Business: Diagnostic FDA granted a CLIA waiver to Alere i Strep A test to detect group A Streptococcus bacteria in throat swab specimens. FDA approved …

    Published on 8/17/2015
  • Brintellix vortioxetine regulatory update

    H. Lundbeck A/S (CSE:LUN), Copenhagen, Denmark Takeda Pharmaceutical Co. Ltd. (Tokyo:4502), Osaka, Japan Product: Brintellix vortioxetine (Trintellix) (formerly Lu AA21004) Business: Neurology FDA accepted for review an…

    Published on 8/17/2015
  • Buprenorphine/naloxone regulatory update

    Orexo AB (SSE:ORX; OTCQX:ORXOY), Uppsala, Sweden Product: Buprenorphine/naloxone (Zubsolv) (OX219) Business: Neurology FDA approved an expanded indication for Zubsolv buprenorphine/naloxone to include the induction of …

    Published on 8/17/2015
  • Cervarix regulatory update

    GlaxoSmithKline plc (LSE:GSK; NYSE:GSK), London, U.K. Product: Cervarix Business: Infectious EMAs Pharmacovigilance Risk Assessment Committee (PRAC) began a safety review of human papillomavirus (HPV) vaccines, …

    Published on 8/17/2015
  • Deutetrabenazine regulatory update

    Teva Pharmaceutical Industries Ltd. (NYSE:TEVA), Petah Tikva, Israel Product: Deutetrabenazine (Austedo) (SD-809) Business: Neurology FDA accepted for review an NDA from Teva for SD-809 to treat chorea associated with …

    Published on 8/17/2015
  • Firdapse amifampridine regulatory update

    Catalyst Pharmaceuticals Inc. (NASDAQ:CPRX), Coral Gables, Fla. BioMarin Pharmaceutical Inc. (NASDAQ:BMRN), Novato, Calif. Product: Firdapse amifampridine Business: Autoimmune Catalyst began submitting a rolling NDA for…

    Published on 8/17/2015
  • Gardasil 9 regulatory update

    Merck & Co. Inc. (NYSE:MRK), Kenilworth, N.J. Sanofi (Euronext:SAN; NYSE:SNY), Paris, France Product: Gardasil 9 Business: Cancer EMAs Pharmacovigilance Risk Assessment Committee (PRAC) began a safety review of human …

    Published on 8/17/2015

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