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Chronological Index of : Regulatory

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  • Revolade eltrombopag regulatory update

    Ligand Pharmaceuticals Inc. (NASDAQ:LGND), La Jolla, Calif. GlaxoSmithKline plc (LSE:GSK; NYSE:GSK), London, U.K. Product: Revolade eltrombopag (Promacta) Business: Autoimmune Ligand said GlaxoSmithKline submitted a …

    Published on 2/16/2015
  • Scenesse afamelanotide regulatory update

    Biotech Lab Singapore Ltd., Singapore Clinuvel Pharmaceuticals Ltd. (ASX:CUV; Pink:CLVLY), Melbourne, Australia Product: Scenesse afamelanotide (CUV1647) (formerly Melanotan) Business: Endocrine/Metabolic In December, …

    Published on 2/16/2015
  • Stendra avanafil regulatory update

    Vivus Inc. (NASDAQ:VVUS), Mountain View, Calif. Mitsubishi Tanabe Pharma Corp. (Tokyo:4508), Osaka, Japan Sanofi (Euronext:SAN; NYSE:SNY), Paris, France Product: Stendra avanafil (Spedra, Zepeed) Business: …

    Published on 2/16/2015
  • TissuGlu Surgical Adhesive regulatory update

    Cohera Medical Inc., Pittsburgh, Pa. Product: TissuGlu Surgical Adhesive Business: Dermatology FDA approved TissuGlu Surgical Adhesive from Cohera to adhere tissue layers and close dead space in abdominoplasty …

    Published on 2/16/2015
  • Treximet sumatriptan/naproxen regulatory update

    Pernix Therapeutics Holdings Inc. (NASDAQ:PTX), Morristown, N.J. Pozen Inc. (NASDAQ:POZN), Chapel Hill, N.C. GlaxoSmithKline plc (LSE:GSK; NYSE:GSK), London, U.K. Product: Treximet sumatriptan/naproxen (formerly Trexima…

    Published on 2/16/2015
  • Triumeq dolutegravir/abacavir/lamivudine regulatory update

    ViiV Healthcare Ltd., Brentford, U.K. Product: Triumeq dolutegravir/abacavir/lamivudine (572-Trii) (S-349572/S-265744/S-247303) Business: Infectious Germanys Institute for Quality and Efficiency in Healthcare (IQWiG) …

    Published on 2/16/2015
  • Velcade bortezomib regulatory update

    Takeda Pharmaceutical Co. Ltd. (Tokyo:4502), Osaka, Japan Johnson & Johnson (NYSE:JNJ), New Brunswick, N.J. Product: Velcade bortezomib Business: Cancer Johnson & Johnsons subsidiary Janssen-Cilag International N.V. …

    Published on 2/16/2015
  • Velphoro sucroferric oxyhydroxide regulatory update

    Fresenius SE & Co. KGaA (Xetra:FRE; OTCQX:FSNUY), Bad Homburg, Germany Galenica Ltd. (SIX:GALN), Bern, Switzerland Kissei Pharmaceutical Co. Ltd. (Tokyo:4547), Nagano, Japan Product: Velphoro sucroferric oxyhydroxide (…

    Published on 2/16/2015
  • Xeljanz tofacitinib regulatory update

    Pfizer Inc. (NYSE:PFE), New York, N.Y. Product: Xeljanz tofacitinib (Jaquinus) (CP-690,550) (formerly tasocitinib) Business: Autoimmune Pfizer said FDA accepted for review an sNDA for 5 and 10 mg Xeljanz tofacitinib …

    Published on 2/16/2015
  • Zohydro ER hydrocodone with BeadTek regulatory update

    Zogenix Inc. (NASDAQ:ZGNX), San Diego, Calif. Product: Zohydro ER hydrocodone with BeadTek Business: Neurology FDA approved Zohydro ER hydrocodone with BeadTek from Zogenix to manage pain severe enough to require daily,…

    Published on 2/16/2015
  • Zydelig idelalisib regulatory update

    Gilead Sciences Inc. (NASDAQ:GILD), Foster City, Calif. Product: Zydelig idelalisib (formerly GS-1101, CAL-101, GS 1101) Business: Cancer Germanys Institute for Quality and Efficiency in Healthcare (IQWiG) said in an …

    Published on 2/16/2015
  • Ai Bi Wei regulatory update

    Chinese Academy of Sciences, Beijing, China Product: Ai Bi Wei (IPV vaccine) Business: Infectious China approved Ai Bi Wei vaccine from the Institute of Medical Biology of the Chinese Academy of Sciences to prevent …

    Published on 2/9/2015
  • Amitiza lubiprostone regulatory update

    Sucampo Pharmaceuticals Inc. (NASDAQ:SCMP), Bethesda, Md. Takeda Pharmaceutical Co. Ltd. (Tokyo:4502), Osaka, Japan Product: Amitiza lubiprostone (SPI-0211) Business: Gastrointestinal Sucampo said Amitiza lubiprostone …

    Published on 2/9/2015
  • BJI InoPlex regulatory update

    Diaxonhit (Euronext:ALEHT), Paris, France Product: BJI InoPlex Business: Diagnostic Diaxonhit received CE Mark approval for BJI InoPlex test to diagnose prosthetic bone and joint infections. The company said it will …

    Published on 2/9/2015
  • Calcipotriene/betamethasone dipropionate aerosol foam regulatory update

    Leo Pharma A/S, Ballerup, Denmark Product: Calcipotriene/betamethasone dipropionate aerosol foam Business: Autoimmune Leo Pharma submitted an NDA to FDA for calcipotriene/betamethasone dipropionate aerosol foam to treat…

    Published on 2/9/2015
  • Cobas MRSA/SA test regulatory update

    Roche (SIX:ROG; OTCQX:RHHBY), Basel, Switzerland Product: Cobas MRSA/SA test Business: Diagnostic FDA granted 510(k) clearance to the cobas MRSA/SA test from Roche to simultaneously detect methicillin-resistant and …

    Published on 2/9/2015
  • Cobas TaqScreen MPX Test v2 regulatory update

    Roche (SIX:ROG; OTCQX:RHHBY), Basel, Switzerland Product: Cobas TaqScreen MPX Test v2.0 Business: Diagnostic FDA approved Roches cobas TaqScreen MPX Test v2.0 to detect and identify HIV, HCV and HBV in donated human …

    Published on 2/9/2015
  • Duopa carbidopa/levodopa regulatory update

    AbbVie Inc. (NYSE:ABBV), Chicago, Ill. Product: Duopa carbidopa/levodopa (Duodopa) Business: Neurology FDA approved an NDA from AbbVie for Duopa carbidopa/levodopa to treat motor fluctuations in patients with advanced …

    Published on 2/9/2015
  • Epidaza chidamide regulatory update

    Gold NanoTech Inc., Taipei, Taiwan Huya Bioscience International LLC, San Diego, Calif. Quintiles Transnational Holdings Inc. (NYSE:Q), Research Triangle Park, N.C. Shenzhen Chipscreen Biosciences Ltd., Shenzhen, China …

    Published on 2/9/2015
  • ETC-1002 regulatory update

    Esperion Therapeutics Inc. (NASDAQ:ESPR), Plymouth, Mich. Product: ETC-1002 Business: Endocrine/Metabolic Esperion said FDA lifted a partial clinical hold on ETC-1002, which is in Phase II testing to treat …

    Published on 2/9/2015
  • Eylea aflibercept ophthalmic solution regulatory update

    Regeneron Pharmaceuticals Inc. (NASDAQ:REGN), Tarrytown, N.Y. Bayer AG (Xetra:BAYN), Leverkusen, Germany Product: Eylea aflibercept ophthalmic solution (VEGF Trap-Eye) Business: Ophthalmic EMAs CHMP recommended approval…

    Published on 2/9/2015
  • Feraccru ferric maltol regulatory update

    Shield Therapeutics AG, Wollerau, Switzerland Product: Feraccru ferric maltol (ST10) Business: Hematology Shield said EMA accepted for review an MAA for oral Feraccru ferric maltol to treat iron deficiency anemia in …

    Published on 2/9/2015
  • Fluad Pediatric regulatory update

    Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland Product: Fluad Pediatric Business: Infectious Health Canada approved Fluad Pediatric vaccine from Novartis to prevent seasonal influenza infection in children ages 6 …

    Published on 2/9/2015
  • Gadavist gadobutrol regulatory update

    Bayer AG (Xetra:BAYN), Leverkusen, Germany Product: Gadavist gadobutrol (Gadovist-EU) Business: Diagnostic FDA approved an sNDA from Bayer for Gadavist gadobutrol as an MRI contrast agent to detect and visualize areas …

    Published on 2/9/2015
  • Glyxambi empagliflozin/linagliptin regulatory update

    Boehringer Ingelheim GmbH, Ingelheim, Germany Eli Lilly and Co. (NYSE:LLY), Indianapolis, Ind. Product: Glyxambi empagliflozin/linagliptin Business: Endocrine/Metabolic FDA approved an NDA from Boehringer for Glyxambi …

    Published on 2/9/2015

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