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Chronological Index of : Regulatory

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  • AmpliVue Bordetella Assay regulatory update

    Quidel Corp. (NASDAQ:QDEL), San Diego, Calif. Product: AmpliVue Bordetella Assay Business: Diagnostic FDA granted 510(k) clearance to Quidels AmpliVue Bordetella Assay to detect Bordetella pertussis nucleic acids …

    Published on 1/26/2015
  • Cangrelor regulatory update

    The Medicines Co. (NASDAQ:MDCO), Parsippany, N.J. AstraZeneca plc (LSE:AZN; NYSE:AZN), London, U.K. Product: Cangrelor (Kengrexal) (formerly AR-C69931MX) Business: Cardiovascular EMAs CHMP recommended approval of …

    Published on 1/26/2015
  • Cosentyx secukinumab regulatory update

    Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland Product: Cosentyx secukinumab (AIN457) Business: Autoimmune The European Commission and FDA approved Cosentyx secukinumab from Novartis to treat moderate to severe …

    Published on 1/26/2015
  • Cresemba isavuconazonium regulatory update

    Basilea Pharmaceutica AG (SIX:BSLN), Basel, Switzerland Astellas Pharma Inc. (Tokyo:4503), Tokyo, Japan Product: Cresemba isavuconazonium (BAL8557) Business: Infectious FDAs Anti-Infective Drugs Advisory Committee …

    Published on 1/26/2015
  • Deoxycholic acid regulatory update

    Kythera Biopharmaceuticals Inc. (NASDAQ:KYTH), Calabasas, Calif. Product: Deoxycholic acid (ATX-101) Business: Other FDAs Dermatologic and Ophthalmic Drugs Advisory Committee scheduled a meeting on March 9 to review an …

    Published on 1/26/2015
  • Dutrebis lamivudine/raltegravir regulatory update

    Merck & Co. Inc. (NYSE:MRK), Whitehouse Station, N.J. Product: Dutrebis lamivudine/raltegravir Business: Infectious EMAs CHMP recommended approval of Dutrebis lamivudine/raltegravir to treat HIV-1 infection in patients …

    Published on 1/26/2015
  • Entyvio vedolizumab regulatory update

    Takeda Pharmaceutical Co. Ltd. (Tokyo:4502), Osaka, Japan Product: Entyvio vedolizumab (MLN0002) Business: Autoimmune The U.K.s NICE issued a preliminary appraisal recommending against Entyvio vedolizumab from Takedas …

    Published on 1/26/2015
  • Gardasil 9 regulatory update

    Merck & Co. Inc. (NYSE:MRK), Whitehouse Station, N.J. Product: Gardasil 9 Business: Infectious FDA approved Gardasil 9 HPV vaccine from Merck to prevent cervical, vulvar, vaginal and anal cancers caused by HPV types 16,…

    Published on 1/26/2015
  • Ikervis ciclosporin regulatory update

    Santen Pharmaceutical Co. Ltd. (Tokyo:4536), Osaka, Japan Product: Ikervis ciclosporin (Cyclokat) (Nova22007) Business: Ophthalmic EMAs CHMP recommended approval of Ikervis ciclosporin eye drops from Santen to treat …

    Published on 1/26/2015
  • Inlyta axitinib regulatory update

    SFJ Pharmaceuticals Inc., Pleasanton, Calif. Pfizer Inc. (NYSE:PFE), New York, N.Y. Product: Inlyta axitinib (formerly AG-013736) Business: Cancer The U.K.s NICE issued a final appraisal determination (FAD) recommending…

    Published on 1/26/2015
  • Jardiance empagliflozin regulatory update

    Boehringer Ingelheim GmbH, Ingelheim, Germany Eli Lilly and Co. (NYSE:LLY), Indianapolis, Ind. Product: Jardiance empagliflozin (BI-10773) Business: Endocrine/Metabolic NICE issued draft guidance recommending Jardiance …

    Published on 1/26/2015
  • My5-FU regulatory update

    Saladax Biomedical Inc., Bethlehem, Pa. Product: My5-FU (formerly OnDose) Business: Diagnostic The U.K.s NICE issued final guidance concluding there is insufficient evidence to determine whether Saladaxs My5-FU …

    Published on 1/26/2015
  • Orbactiv oritavancin regulatory update

    The Medicines Co. (NASDAQ:MDCO), Parsippany, N.J. Product: Orbactiv oritavancin (formerly LY333328) Business: Infectious EMAs CHMP recommended approval of IV Orbactiv oritavancin from The Medicines Co. to treat acute …

    Published on 1/26/2015
  • PLAC Test for Lp-PLA2 Activity regulatory update

    diaDexus Inc. (OTCBB:DDXS), South San Francisco, Calif. Product: PLAC Test for Lp-PLA2 Activity Business: Diagnostic Last month, FDA granted 510(k) clearance to the PLAC Test for Lp-PLA2 Activity from diaDexus as an aid…

    Published on 1/26/2015
  • QuickShot Testosterone regulatory update

    Antares Pharma Inc. (NASDAQ:ATRS), Ewing, N.J. Product: QuickShot Testosterone Business: Endocrine/Metabolic FDA told Antares to expand its safety database for QuickShot Testosterone, which is in Phase III testing to …

    Published on 1/26/2015
  • Raplixa regulatory update

    The Medicines Co. (NASDAQ:MDCO), Parsippany, N.J. Product: Raplixa (formerly Fibrocaps) Business: Hematology EMAs CHMP recommended approval of Raplixa from The Medicines Co. as supportive treatment in adults where …

    Published on 1/26/2015
  • SB4 regulatory update

    Biogen Idec Inc. (NASDAQ:BIIB), Cambridge, Mass. Samsung Group, Seoul, South Korea Product: SB4 Business: Autoimmune EMA accepted for review an MAA from Samsung Bioepis Co. Ltd. for SB4, a biosimilar of autoimmune drug …

    Published on 1/26/2015
  • Seebri Breezhaler glycopyrronium bromide regulatory update

    Sosei Group Corp. (Tokyo:4565), Tokyo, Japan Vectura Group plc (LSE:VEC), Chippenham, U.K. Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland Product: Seebri Breezhaler glycopyrronium bromide (NVA237) (formerly AD 237…

    Published on 1/26/2015
  • Signifor LAR pasireotide regulatory update

    Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland Product: Signifor LAR pasireotide Business: Endocrine/Metabolic FDA approved once-monthly Signifor LAR pasireotide from Novartis to treat acromegaly in patients who …

    Published on 1/26/2015
  • Syphilis Health Check regulatory update

    Diagnostics Direct LLC, Cape May Court House, N.J. Product: Syphilis Health Check Business: Diagnostic FDA granted a CLIA waiver to Diagnostics Directs Syphilis Health Check test to detect syphilis. The point-of-care …

    Published on 1/26/2015
  • Ultibro Breezhaler indacaterol/glycopyrronium bromide regulatory update

    Sosei Group Corp. (Tokyo:4565), Tokyo, Japan Vectura Group plc (LSE:VEC), Chippenham, U.K. Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland Product: Ultibro Breezhaler indacaterol/glycopyrronium bromide (QVA149) …

    Published on 1/26/2015
  • Xtampza ER oxycodone extended-release regulatory update

    Collegium Pharmaceutical Inc., Canton, Mass. Product: Xtampza ER oxycodone extended-release Business: Neurology Last month, Collegium submitted an NDA to FDA for oral Xtampza ER oxycodone extended-release to treat …

    Published on 1/26/2015
  • Abilify Maintena aripiprazole regulatory update

    H. Lundbeck A/S (CSE:LUN), Copenhagen, Denmark Otsuka Pharmaceutical Co. Ltd., Tokyo, Japan Product: Abilify Maintena aripiprazole Business: Neurology FDA approved an sNDA from Otsuka for once-monthly Abilify Maintena …

    Published on 1/19/2015
  • Alere Determine HIV-1/2 Ag/Ab Combo test regulatory update

    Alere Inc. (NYSE:ALR), Waltham, Mass. Product: Alere Determine HIV-1/2 Ag/Ab Combo test Business: Diagnostic FDA granted a CLIA waiver to Alere Determine HIV-1/2 Ag/Ab Combo test from Alere as an aid in diagnosing HIV-1…

    Published on 1/19/2015
  • APPY1 regulatory update

    Venaxis Inc. (NASDAQ:APPY), Castle Rock, Colo. Product: APPY1 (formerly AppyScore) Business: Diagnostic Venaxis submitted a response to FDAs request for information related to its 510(k) application for APPY1 to aid …

    Published on 1/19/2015

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