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Chronological Index of : Regulatory

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  • 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 FDAs Psychopharmacologic …

    Published on 2/8/2016
  • Coagadex regulatory update

    Bio Products Laboratory Ltd., Elstree, U.K. Product: Coagadex Business: Hematology EMAs CHMP recommended approval of Coagadex from Bio Products to treat and prevent bleeding episodes and for perioperative management in …

    Published on 2/8/2016
  • ELI-200 regulatory update

    Elite Pharmaceuticals Inc. (OTCQB:ELTP), Northvale, N.J. Product: ELI-200 Business: Neurology Elite submitted an NDA to FDA for ELI-200 to treat moderate to severe pain. The product is an abuse deterrent-formulation of …

    Published on 2/8/2016
  • Eltrombopag regulatory update

    Ligand Pharmaceuticals Inc. (NASDAQ:LGND), La Jolla, Calif. Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland Product: Eltrombopag Business: Autoimmune EMAs CHMP recommended expanding the label of Revolade …

    Published on 2/8/2016
  • 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 EMAs CHMP recommended Empliciti elotuzumab from Bristol-…

    Published on 2/8/2016
  • Halaven eribulin mesylate regulatory update

    Eisai Co. Ltd. (Tokyo:4523), Tokyo, Japan Product: Halaven eribulin mesylate (E7389) Business: Cancer FDA approved an sNDA from Eisai for Halaven eribulin mesylate to treat unresectable or metastatic liposarcoma in …

    Published on 2/8/2016
  • IV SCY-078 regulatory update

    Scynexis Inc. (NASDAQ:SCYX), Research Triangle Park, N.C. Product: IV SCY-078 Business: Infectious FDA granted Fast Track and Qualified Infectious Disease Product (QIDP) designations to IV SCY-078 to treat invasive …

    Published on 2/8/2016
  • Masitinib regulatory update

    AB Science S.A. (Euronext:AB), Paris, France Product: Masitinib (Masican) (AB1010) Business: Dermatology AB Science plans to submit an MAA to EMA by the end of this quarter for masitinib to treat severe systemic …

    Published on 2/8/2016
  • MCNA regulatory update

    Ipsen Group (Euronext:IPN; Pink:IPSEY), Boulogne-Billancourt, France Telesta Therapeutics Inc. (TSX:TST; Pink:BNHLF), Belleville, Ontario Product: MCNA (EN3348) (formerly Urocidin) Business: Cancer FDA issued a complete…

    Published on 2/8/2016
  • Nuplazid pimavanserin regulatory update

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD), San Diego, Calif. Product: Nuplazid pimavanserin (formerly ACP-103) Business: Neurology FDAs Psychopharmacologic Drugs Advisory Committee will meet on March 29 to discuss an …

    Published on 2/8/2016
  • Onzetra Xsail sumatriptan nasal powder regulatory update

    OptiNose Inc., Yardley, Pa. Otsuka Pharmaceutical Co. Ltd., Tokyo, Japan Product: Onzetra Xsail sumatriptan nasal powder (formerly AVP-825) Business: Neurology FDA approved an NDA from Otsukas Avanir Pharmaceuticals Inc…

    Published on 2/8/2016
  • Plecanatide regulatory update

    Synergy Pharmaceuticals Inc. (NASDAQ:SGYP), New York, N.Y. Product: Plecanatide (formerly SP-304) Business: Gastrointestinal Synergy submitted an NDA to FDA for plecanatide to treat chronic idiopathic constipation (CIC…

    Published on 2/8/2016
  • Rapastinel regulatory update

    Allergan plc (NYSE:AGN), Dublin, Ireland Product: Rapastinel (GLYX-13) (formerly NT-13) Business: Neurology FDA granted breakthrough therapy designation to rapastinel from Allergan for adjunctive treatment of major …

    Published on 2/8/2016
  • Revlimid lenalidomide regulatory update

    Celgene Corp. (NASDAQ:CELG), Summit, N.J. Product: Revlimid lenalidomide (formerly CDC 501) Business: Cancer EMAs CHMP recommended expanding the label of Revlimid lenalidomide from Celgene to include the treatment of …

    Published on 2/8/2016
  • Tagrisso osimertinib regulatory update

    AstraZeneca plc (LSE:AZN; NYSE:AZN), London, U.K. Product: Tagrisso osimertinib (AZD9291) Business: Cancer The European Commission granted conditional approval of Tagrisso osimertinib from AstraZeneca to treat locally …

    Published on 2/8/2016
  • Truvada emtricitabine/tenofovir regulatory update

    Gilead Sciences Inc. (NASDAQ:GILD), Foster City, Calif. Product: Truvada emtricitabine/tenofovir Business: Infectious EMA accepted for review a Type II variation application from Gilead seeking to expand the label of …

    Published on 2/8/2016
  • Uptravi selexipag regulatory update

    Actelion Ltd. (SIX:ATLN), Allschwil, Switzerland Nippon Shinyaku Co. Ltd. (Tokyo:4516), Kyoto, Japan Product: Uptravi selexipag (NS-304, ACT-293987) Business: Cardiovascular EMAs CHMP recommended Uptravi selexipag from …

    Published on 2/8/2016
  • Zembrace SymTouch sumatriptan succinate regulatory update

    Dr. Reddys Laboratories Ltd. (NYSE:RDY), Hyderabad, India Product: Zembrace SymTouch sumatriptan succinate Business: Neurology FDA approved an NDA from Dr. Reddys for Zembrace SymTouch sumatriptan succinate to treat …

    Published on 2/8/2016
  • ABP 501 regulatory update

    Amgen Inc. (NASDAQ:AMGN), Thousand Oaks, Calif. Product: ABP 501 Business: Autoimmune FDA accepted for review a BLA from Amgen for ABP 501, a biosimilar of autoimmune drug Humira adalimumab from AbbVie Inc. (NYSE:ABBV, …

    Published on 2/1/2016
  • Adzenys XR-ODT amphetamine regulatory update

    Neos Therapeutics Inc. (NASDAQ:NEOS), Grand Prairie, Texas Shire plc (LSE:SHP; NASDAQ:SHPG), Dublin, Ireland Product: Adzenys XR-ODT amphetamine (NT-0202) Business: Neurology FDA approved an NDA from Neos for Adzenys XR…

    Published on 2/1/2016
  • Bezlotoxumab regulatory update

    Bristol-Myers Squibb Co. (NYSE:BMY), New York, N.Y. Merck & Co. Inc. (NYSE:MRK), Kenilworth, N.J. Product: Bezlotoxumab (MK-6072) (formerly MDX-1388, CDB-1) Business: Infectious FDA accepted and granted Priority Review …

    Published on 2/1/2016
  • Boniva ibandronate regulatory update

    Chugai Pharmaceutical Co. Ltd. (Tokyo:4519), Tokyo, Japan Taisho Pharmaceutical Holdings Co. Ltd. (Tokyo:4581), Tokyo, Japan Roche (SIX:ROG; OTCQX:RHHBY), Basel, Switzerland Product: Boniva ibandronate Business: …

    Published on 2/1/2016
  • Botox onabotulinumtoxinA regulatory update

    Allergan plc (NYSE:AGN), Dublin, Ireland Product: Botox onabotulinumtoxinA (formerly botulinum toxin) Business: Musculoskeletal Allergan (formerly Actavis plc) said FDA approved Botox onabotulinumtoxinA to treat lower …

    Published on 2/1/2016
  • 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 (KHK4827) (formerly AMG…

    Published on 2/1/2016
  • Cabozantinib regulatory update

    Exelixis Inc. (NASDAQ:EXEL), South San Francisco, Calif. Product: Cabozantinib (XL184) Business: Cancer Exelixis said FDA accepted and granted Priority Review to an NDA and EMA accepted an MAA for a tablet formulation …

    Published on 2/1/2016

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