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Chronological Index of : Regulatory

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  • AR101 regulatory update

    Aimmune Therapeutics Inc., Brisbane, Calif. Product: AR101 (formerly Peanut Allergy Oral Immunotherapy (OIT), ARC001) Business: Inflammation FDA granted breakthrough therapy designation to AR101 from Aimmune to treat …

    Published on 6/29/2015
  • Brio Neurostimulation System regulatory update

    St. Jude Medical Inc. (NYSE:STJ), St. Paul, Minn. Product: Brio Neurostimulation System Business: Neurology FDA approved a PMA from St. Judes for the Brio Neurostimulation System to treat patients with Parkinsons …

    Published on 6/29/2015
  • Daytrana Methylphenidate regulatory update

    Hisamitsu Pharmaceutical Co. Inc. (Tokyo:4530), Tosu, Japan Product: Daytrana Methylphenidate Business: Neurology FDA issued a drug safety communication warning that permanent loss of skin color may occur with the use …

    Published on 6/29/2015
  • Encenicline regulatory update

    Forum Pharmaceuticals Inc., Waltham, Mass. Bayer AG (Xetra:BAYN), Leverkusen, Germany Product: Encenicline (EVP-6124, MT-4666) Business: Neurology FDA granted Fast Track designation to encenicline from Forum to treat …

    Published on 6/29/2015
  • Farydak panobinostat regulatory update

    Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland Product: Farydak panobinostat (LBH589) Business: Cancer EMAs CHMP recommended approval of Farydak panobinostat in combination with Velcade bortezomib and …

    Published on 6/29/2015
  • Fycompa perampanel regulatory update

    Eisai Co. Ltd. (Tokyo:4523), Tokyo, Japan Product: Fycompa perampanel (E2007) Business: Neurology The European Commission approved an MAA from Eisai for Fycompa perampanel as a once-daily, adjunctive treatment for …

    Published on 6/29/2015
  • Gardasil 9 regulatory update

    Merck & Co. Inc. (NYSE:MRK), Kenilworth, N.J. Sanofi (Euronext:SAN; NYSE:SNY), Paris, France Product: Gardasil 9 Business: Infectious The European Commission approved Gardasil 9 from Merck to prevent cancers caused by 9…

    Published on 6/29/2015
  • Humira adalimumab regulatory update

    AbbVie Inc. (NYSE:ABBV), Chicago, Ill. Eisai Co. Ltd. (Tokyo:4523), Tokyo, Japan Product: Humira adalimumab Business: Dermatology EMAs CHMP recommended approval of Humira adalimumab from AbbVie to treat moderate to …

    Published on 6/29/2015
  • Idylla KRAS Mutation Test regulatory update

    Biocartis Group N.V. (Euronext:BCART), Mechelen, Belgium Product: Idylla KRAS Mutation Test Business: Diagnostic Biocartis received CE Mark approval for Idylla KRAS Mutation Test to detect clinically relevant mutations …

    Published on 6/29/2015
  • Kanuma sebelipase alfa regulatory update

    Alexion Pharmaceuticals Inc. (NASDAQ:ALXN), Cheshire, Conn. Product: Kanuma sebelipase alfa (formerly SBC-102) Business: Endocrine/Metabolic EMAs CHMP recommended approval of Kanuma sebelipase alfa from Alexion as a …

    Published on 6/29/2015
  • Long Acting rFactor lX regulatory update

    Biogen Inc. (NASDAQ:BIIB), Cambridge, Mass. Swedish Orphan Biovitrum AB (SSE:SOBI), Stockholm, Sweden Product: Long Acting rFactor lX, rFIXFc (Alprolix) Business: Hematology Biogen said EMA accepted for review an MAA …

    Published on 6/29/2015
  • Lutathera regulatory update

    Advanced Accelerator Applications S.A., Saint Genis Pouilly, France Covidien plc (NYSE:COV), Dublin, Ireland Product: Lutathera, 177Lu-DOTA0-Tyr3-Octreotate Business: Cancer FDA granted Fast Track designation to …

    Published on 6/29/2015
  • Octreotide acetate regulatory update

    Chiasma Inc., Jerusalem, Israel Product: Octreotide acetate (Octreolin) (RG3806) Business: Endocrine/Metabolic Chiasma submitted an NDA to FDA for octreotide for maintenance treatment of acromegaly in adults. The …

    Published on 6/29/2015
  • 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 The European Commission approved …

    Published on 6/29/2015
  • Raxone idebenone regulatory update

    Santhera Pharmaceuticals Holding AG (SIX:SANN), Liestal, Switzerland Product: Raxone idebenone (SNT-MC17) Business: Ophthalmic EMAs CHMP recommended approval of Raxone idebenone to treat visual impairment in adolescent …

    Published on 6/29/2015
  • Strensiq asfotase alfa regulatory update

    Alexion Pharmaceuticals Inc. (NASDAQ:ALXN), Cheshire, Conn. Product: Strensiq asfotase alfa (ENB-0040) Business: Endocrine/Metabolic EMAs CHMP recommended approval of Strensiq asfotase alfa from Alexion as a long-term …

    Published on 6/29/2015
  • Ventana ALK regulatory update

    Cell Signaling Technology Inc., Danvers, Mass. Pfizer Inc. (NYSE:PFE), New York, N.Y. Roche (SIX:ROG; OTCQX:RHHBY), Basel, Switzerland Product: Ventana ALK (D5F3) CDx Assay Business: Diagnostic FDA approved the Ventana …

    Published on 6/29/2015
  • AstraZeneca, Boehringer Ingelheim, Eli Lilly, J&J, Mitsubishi Tanabe Pharma regulatory update

    AstraZeneca plc (LSE:AZN; NYSE:AZN), London, U.K. Boehringer Ingelheim GmbH, Ingelheim, Germany Eli Lilly and Co. (NYSE:LLY), Indianapolis, Ind. Johnson & Johnson (NYSE:JNJ), New Brunswick, N.J. Mitsubishi Tanabe Pharma…

    Published on 6/22/2015
  • Cariprazine regulatory update

    Allergan plc (NYSE:AGN), Dublin, Ireland Gedeon Richter Ltd. (Budapest:RICHTER), Budapest, Hungary Product: Cariprazine (RGH-188, MP-214) Business: Neurology Allergan (formerly Actavis plc) and Gedeon said FDA extended …

    Published on 6/22/2015
  • JVS-100 regulatory update

    Juventas Therapeutics Inc., Cleveland, Ohio Product: JVS-100 Business: Cardiovascular FDA granted Fast Track designation to JVS-100 from Juventas to treat advanced ischemic chronic heart failure (CHF). Juventas plans to…

    Published on 6/22/2015
  • Promacta eltrombopag regulatory update

    Ligand Pharmaceuticals Inc. (NASDAQ:LGND), La Jolla, Calif. Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland Product: Promacta eltrombopag (Revolade) Business: Autoimmune FDA approved an sNDA from Novartis for …

    Published on 6/22/2015
  • Reslizumab regulatory update

    Teva Pharmaceutical Industries Ltd. (NYSE:TEVA), Petah Tikva, Israel Product: Reslizumab (formerly Cinquil) Business: Inflammation FDA accepted for review a BLA from Teva for IV reslizumab to treat inadequately …

    Published on 6/22/2015
  • Zomig zolmitriptan regulatory update

    Impax Laboratories Inc. (NASDAQ:IPXL), Hayward, Calif. AstraZeneca plc (LSE:AZN; NYSE:AZN), London, U.K. Product: Zomig zolmitriptan Business: Neurology FDA approved an sNDA from AstraZeneca for Zomig zolmitriptan nasal…

    Published on 6/22/2015
  • Actemra regulatory update

    Genentech Inc., South San Francisco, Calif. Chugai Pharmaceutical Co. Ltd. (Tokyo:4519), Tokyo, Japan Roche (SIX:ROG; OTCQX:RHHBY), Basel, Switzerland Product: Actemra ( RoActemra - EU) tocilizumab (RG1569) Business: …

    Published on 6/15/2015
  • Addyi flibanserin regulatory update

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

    Published on 6/15/2015

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