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Chronological Index of : Regulatory

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  • Adempas riociguat regulatory update

    Bayer AG (Xetra:BAYN), Leverkusen, Germany Product: Adempas riociguat (BAY 63-2521) Business: Cardiovascular The European Commission approved Adempas riociguat from Bayer to treat pulmonary arterial hypertension (PAH) …

    Published on 4/7/2014
  • Afrezza regulatory update

    MannKind Corp. (NASDAQ:MNKD), Valencia, Calif. Product: Afrezza (formerly Afresa) Business: Endocrine/Metabolic FDA's Endocrinologic and Metabolic Drugs Advisory Committee said MannKind showed that Afrezza is safe and …

    Published on 4/7/2014
  • Aldoxorubicin regulatory update

    CytRx Corp. (NASDAQ:CYTR), Los Angeles, Calif. Product: Aldoxorubicin (formerly DOXO-EMCH, INNO-206) Business: Cancer The European Commission granted Orphan Drug designation for aldoxorubicin to treat advanced soft …

    Published on 4/7/2014
  • AmpliVue HSV 1+2 Assay regulatory update

    Quidel Corp. (NASDAQ:QDEL), San Diego, Calif. Product: AmpliVue HSV 1+2 Assay Business: Diagnostic Quidel said FDA granted 510(k) clearance for AmpliVue HSV 1+2 Assay to detect and differentiate herpes simplex virus …

    Published on 4/7/2014
  • APPY1 regulatory update

    Venaxis Inc. (NASDAQ:APPY), Castle Rock, Colo. Product: APPY1 (formerly AppyScore) Business: Diagnostic Venaxis submitted a 510(k) application to FDA for APPY1 to identify patients that are at low risk for appendicitis.…

    Published on 4/7/2014
  • Autologous T cell therapy against CD19 regulatory update

    Kite Pharma Inc., Los Angeles, Calif. Product: Autologous T cell therapy against CD19 Business: Cancer FDA granted Orphan Drug designation for Kite's autologous T cell therapy against CD19 to treat diffuse large B cell …

    Published on 4/7/2014
  • BRACAnalysis regulatory update

    Myriad Genetics Inc. (NASDAQ:MYGN), Salt Lake City, Utah Product: BRACAnalysis Business: Diagnostic Myriad disclosed in an SEC filing that CMS increased its reimbursement rate for genetic tests for breast cancer 1 early…

    Published on 4/7/2014
  • Dalvance dalbavancin regulatory update

    Durata Therapeutics Inc. (NASDAQ:DRTX), Chicago, Ill. Product: Dalvance dalbavancin (RQ-00000002) Business: Infectious FDA's Anti-Infective Drugs Advisory Committee voted 12-0 in favor of approval of Dalvance …

    Published on 4/7/2014
  • Darunavir/cobicistat regulatory update

    Gilead Sciences Inc. (NASDAQ:GILD), Foster City, Calif. Johnson & Johnson (NYSE:JNJ), New Brunswick, N.J. Product: Darunavir/cobicistat Business: Infectious The Janssen Research & Development LLC unit of Johnson & …

    Published on 4/7/2014
  • Eravacycline regulatory update

    Tetraphase Pharmaceuticals Inc. (NASDAQ:TTPH), Watertown, Mass. Product: Eravacycline (TP-434) Business: Infectious Tetraphase said FDA granted Fast Track designation to both IV and oral formulations of antibiotic …

    Published on 4/7/2014
  • Eviplera emtricitabine/tenofovir/rilpivirine regulatory update

    Gilead Sciences Inc. (NASDAQ:GILD), Foster City, Calif. Johnson & Johnson (NYSE:JNJ), New Brunswick, N.J. Product: Eviplera emtricitabine/tenofovir/rilpivirine (Complera) Business: Infectious Germany's Institute for …

    Published on 4/7/2014
  • Evzio naloxone regulatory update

    Kaleo Inc., Richmond, Va. Product: Evzio naloxone Business: Neurology FDA approved Evzio naloxone from Kaleo for the emergency treatment of suspected or known opioid overdose. The product is a hand-held autoinjector …

    Published on 4/7/2014
  • Fibrocaps regulatory update

    The Medicines Co. (NASDAQ:MDCO), Parsippany, N.J. Product: Fibrocaps Business: Hematology The Medicines Co. said FDA accepted for review a BLA for Fibrocaps to aid in hemostasis during surgery when control of mild or …

    Published on 4/7/2014
  • Graspa regulatory update

    Erytech Pharma S.A. (Euronext:ERYP), Lyon, France Product: Graspa (ERY-ASP) Business: Cancer Erytech said FDA granted Orphan Drug designation for ERY-ASP to treat acute myelogenous leukemia (AML). ERY-ASP has Orphan …

    Published on 4/7/2014
  • Illumigene Pertussis regulatory update

    Meridian Bioscience Inc. (NASDAQ:VIVO), Cincinnati, Ohio Product: Illumigene Pertussis Business: Diagnostic FDA granted 510(k) clearance for Meridian's illumigene Pertussis test to detect Bordetella pertussis. The …

    Published on 4/7/2014
  • Kadcyla trastuzumab emtansine regulatory update

    Genentech Inc., South San Francisco, Calif. ImmunoGen Inc. (NASDAQ:IMGN), Waltham, Mass. Chugai Pharmaceutical Co. Ltd. (Tokyo:4519), Tokyo, Japan Roche (SIX:ROG; OTCQX:RHHBY), Basel, Switzerland Product: Kadcyla …

    Published on 4/7/2014
  • Lemtrada alemtuzumab regulatory update

    BTG plc (LSE:BTG), London, U.K. Sanofi (Euronext:SAN; NYSE:SNY), Paris, France Product: Lemtrada alemtuzumab (MabCampath, Campath) Business: Autoimmune The U.K.'s NICE issued a final appraisal determination (FAD) …

    Published on 4/7/2014
  • Lyxumia lixisenatide regulatory update

    Zealand Pharma A/S (CSE:ZEAL), Glostrup, Denmark Sanofi (Euronext:SAN; NYSE:SNY), Paris, France Product: Lyxumia lixisenatide (AVE0010, ZP10) Business: Endocrine/Metabolic Sanofi said it will no longer market Type II …

    Published on 4/7/2014
  • NESP darbepoetin alfa regulatory update

    Amgen Inc. (NASDAQ:AMGN), Thousand Oaks, Calif. Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151), Tokyo, Japan Product: NESP darbepoetin alfa (Aranesp) (KRN321) Business: Hematology Kyowa submitted an application to Japan's …

    Published on 4/7/2014
  • Nexium esomeprazole magnesium regulatory update

    AstraZeneca plc (LSE:AZN; NYSE:AZN), London, U.K. Product: Nexium esomeprazole magnesium Business: Gastrointestinal FDA approved an NDA from AstraZeneca for Nexium 24HR esomeprazole 20 mg delayed-release capsules for …

    Published on 4/7/2014
  • Oralair regulatory update

    Endo International plc (NASDAQ:ENDP; TSX:ENL), Dublin, Ireland Stallergenes S.A. (Euronext:GENP), Antony, France Product: Oralair Business: Inflammation FDA approved Oralair from Stallergenes to treat grass pollen-…

    Published on 4/7/2014
  • Pandemic influenza vaccine regulatory update

    Baxter International Inc. (NYSE:BAX), Deerfield, Ill. Takeda Pharmaceutical Co. Ltd. (Tokyo:4502), Osaka, Japan Product: Pandemic influenza vaccine Business: Infectious Takeda said Japan's Ministry of Health, Labor and …

    Published on 4/7/2014
  • Single-agent ribavirin regulatory update

    Pharmascience Inc., Montreal, Quebec Product: Single-agent ribavirin Business: Infectious Pharmascience's Pendopharm division said Health Canada granted Priority Review to an application for single-agent ribavirin to …

    Published on 4/7/2014
  • Sivextro tedizolid phosphate regulatory update

    Cubist Pharmaceuticals Inc. (NASDAQ:CBST), Lexington, Mass. Dong-A Pharmaceutical Co. Ltd. (KSE:000640), Seoul, South Korea Bayer AG (Xetra:BAYN), Leverkusen, Germany Product: Sivextro tedizolid phosphate (TR-701) (…

    Published on 4/7/2014
  • Stelara ustekinumab regulatory update

    Bristol-Myers Squibb Co. (NYSE:BMY), New York, N.Y. Johnson & Johnson (NYSE:JNJ), New Brunswick, N.J. Product: Stelara ustekinumab (CNTO 1275) Business: Autoimmune The U.K.'s NICE issued a final appraisal determination…

    Published on 4/7/2014

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