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Chronological Index of : Regulatory

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  • Axalimogene filolisbac regulatory update

    Advaxis Inc. (NASDAQ:ADXS), Princeton, N.J. Product: Axalimogene filolisbac (ADXS11-001) (formerly Lovaxin C, ADXS-HPV) Business: Cancer EMA classified Advaxis axalimogene filolisbac as an advanced therapy medicinal …

    Published on 7/25/2016
  • Belviq XR lorcaserin extended release regulatory update

    Arena Pharmaceuticals Inc. (NASDAQ:ARNA), San Diego, Calif. Eisai Co. Ltd. (Tokyo:4523), Tokyo, Japan Product: Belviq XR lorcaserin extended release Business: Endocrine/Metabolic Eisai and Arena said FDA approved an NDA…

    Published on 7/25/2016
  • Berinert regulatory update

    CSL Ltd. (ASX:CSL), Melbourne, Australia Product: Berinert (C1-INH concentrate) Business: Inflammation CSL said FDA approved Berinert to treat acute abdominal, facial or laryngeal attacks of hereditary angioedema (HAE) …

    Published on 7/25/2016
  • Bezlotoxumab regulatory update

    Bristol-Myers Squibb Co. (NYSE:BMY), New York, N.Y. Merck & Co. Inc. (NYSE:MRK), Kenilworth, N.J. Product: Bezlotoxumab (Zinplava) (MK-6072) (formerly MDX-1388, CDB-1) Business: Infectious Merck said FDA extended the …

    Published on 7/25/2016
  • Biosimilar adalimumab regulatory update

    Biogen Inc. (NASDAQ:BIIB), Cambridge, Mass. Merck & Co. Inc. (NYSE:MRK), Kenilworth, N.J. Samsung Group, Seoul, South Korea Product: Biosimilar adalimumab (SB5) Business: Autoimmune EMA accepted for review an MAA from …

    Published on 7/25/2016
  • Biosimilar pegfilgrastim regulatory update

    Biocon Ltd. (NSE:BIOCON; BSE:BIOCON), Bangalore, India Mylan N.V. (NASDAQ:MYL), Canonsburg, Pa. Product: Biosimilar pegfilgrastim Business: Hematology Mylan and Biocon said EMA accepted for review an MAA for a …

    Published on 7/25/2016
  • Biosimilar pegfilgrastim regulatory update

    Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland Product: Biosimilar pegfilgrastim (LA-EP2006) Business: Hematology FDA issued a complete response letter to Novartis Sandoz Inc. generics unit for a BLA for LA-EP2006…

    Published on 7/25/2016
  • Brodalumab regulatory update

    Amgen Inc. (NASDAQ:AMGN), Thousand Oaks, Calif. Valeant Pharmaceuticals International Inc. (TSX:VRX; NYSE:VRX), Laval, Quebec AstraZeneca plc (LSE:AZN; NYSE:AZN), London, U.K. Product: Brodalumab (Lumicef) (KHK4827) (…

    Published on 7/25/2016
  • Cervarix regulatory update

    GlaxoSmithKline plc (LSE:GSK; NYSE:GSK), London, U.K. Product: Cervarix Business: Infectious The China FDA approved Cervarix HPV vaccine from GlaxoSmithKline to prevent cervical cancer in women ages 9-25. GSK plans to …

    Published on 7/25/2016
  • Cladribine tablets regulatory update

    Merck KGaA (Xetra:MRK), Darmstadt, Germany Product: Cladribine tablets Business: Autoimmune EMA accepted for review an MAA from Merck for cladribine tablets to treat relapsing-remitting multiple sclerosis (RRMS). In …

    Published on 7/25/2016
  • EBV-CTL regulatory update

    Atara Biotherapeutics Inc. (NASDAQ:ATRA), Brisbane, Calif. Memorial Sloan Kettering Cancer Center, New York, N.Y. Product: EBV-CTL Business: Cancer Atara began a U.S. expanded access protocol of EBV-CTL to treat Epstein…

    Published on 7/25/2016
  • Gattex regulatory update

    Shire plc (LSE:SHP; NASDAQ:SHPG), Dublin, Ireland Product: Gattex ( Revestive - EU) teduglutide (ALX-0600) Business: Gastrointestinal The European Commission approved an expanded label for Revestive teduglutide from …

    Published on 7/25/2016
  • LOXO-101 regulatory update

    Array BioPharma Inc. (NASDAQ:ARRY), Boulder, Colo. Loxo Oncology Inc. (NASDAQ:LOXO), Stamford, Conn. Product: LOXO-101 Business: Cancer Loxo said FDA granted breakthrough therapy designation to LOXO-101 to treat …

    Published on 7/25/2016
  • Masitinib regulatory update

    AB Science S.A. (Euronext:AB), Paris, France Product: Masitinib (Masican) (AB1010) Business: Neurology AB Science said FDA approved an IND for compassionate use of masitinib in 1 patient with amyotrophic lateral …

    Published on 7/25/2016
  • Methylnaltrexone regulatory update

    Progenics Pharmaceuticals Inc. (NASDAQ:PGNX), Tarrytown, N.Y. Valeant Pharmaceuticals International Inc. (TSX:VRX; NYSE:VRX), Laval, Quebec Product: Methylnaltrexone (Oral Relistor) (MOA-728) Business: Gastrointestinal …

    Published on 7/25/2016
  • 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 Bristol-Myers Squibb said FDA and …

    Published on 7/25/2016
  • Oxycodone/naltrexone regulatory update

    Elite Pharmaceuticals Inc. (OTCQB:ELTP), Northvale, N.J. Product: Oxycodone/naltrexone (SequestOx) (ELI-200) Business: Neurology FDA issued a complete response letter to Elite for an NDA for SequestOx oxycodone/…

    Published on 7/25/2016
  • Qtern saxagliptin/dapagliflozin regulatory update

    AstraZeneca plc (LSE:AZN; NYSE:AZN), London, U.K. Product: Qtern saxagliptin/dapagliflozin Business: Endocrine/Metabolic The European Commission approved Qtern saxagliptin/dapagliflozin from AstraZeneca to treat adult …

    Published on 7/25/2016
  • Raxone idebenone regulatory update

    Santhera Pharmaceuticals Holding AG (SIX:SANN), Liestal, Switzerland Product: Raxone idebenone (SNT-MC17) Business: Musculoskeletal Santhera said FDA would not support its plan to submit an NDA for Raxone idebenone to …

    Published on 7/25/2016
  • Revlimid lenalidomide regulatory update

    Celgene Corp. (NASDAQ:CELG), Summit, N.J. Product: Revlimid lenalidomide (formerly CDC 501) Business: Cancer The European Commission approved an expanded label for Revlimid lenalidomide from Celgene to include the …

    Published on 7/25/2016
  • ScAAV9 regulatory update

    RegenxBio Inc. (NASDAQ:RGNX), Washington, D.C. AveXis Inc. (NASDAQ:AVXS), Bannockburn, Ill. Product: ScAAV9.CB.SMN (AVXS-101) (formerly chariSMA) Business: Neurology FDA granted breakthrough therapy designation to AVXS-…

    Published on 7/25/2016
  • Telotristat etiprate regulatory update

    Ipsen Group (Euronext:IPN), Boulogne-Billancourt, France Lexicon Pharmaceuticals Inc. (NASDAQ:LXRX), The Woodlands, Texas Product: Telotristat etiprate (LX1032, LX1606) Business: Endocrine/Metabolic Ipsen and Lexicon …

    Published on 7/25/2016
  • Yuvvexy regulatory update

    TherapeuticsMD Inc. (NYSE-M:TXMD), Boca Raton, Fla. Product: Yuvvexy, estradiol VagiCap (TX-004HR) Business: Endocrine/Metabolic TherapeuticsMD submitted an NDA to FDA for Yuvexxy to treat moderate to severe vaginal …

    Published on 7/25/2016
  • Adapalene 0 regulatory update

    Galderma S.A., Lausanne, Switzerland Maruho Co. Ltd., Osaka, Japan Product: Adapalene 0.1%/benzoyl peroxide 2.5% (Epiduo) Business: Dermatology Galderma said Japan approved Epiduo adapalene/benzoyl peroxide to treat …

    Published on 7/18/2016
  • Adcetris brentuximab vedotin regulatory update

    Seattle Genetics Inc. (NASDAQ:SGEN), Bothell, Wash. Takeda Pharmaceutical Co. Ltd. (Tokyo:4502), Osaka, Japan Product: Adcetris brentuximab vedotin (SGN-35) Business: Cancer The European Commission approved an expanded …

    Published on 7/18/2016

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