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Chronological Index of : Regulatory

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  • Adcetris brentuximab vedotin regulatory update

    Seattle Genetics Inc. (NASDAQ:SGEN), Bothell, Wash. Takeda Pharmaceutical Co. Ltd. (Tokyo:4502), Osaka, Japan Product: Adcetris brentuximab vedotin (SGN-35) Business: Cancer Seattle Genetics disclosed in its 4Q13 …

    Published on 2/17/2014
  • AirFluSal Forspiro salmeterol/fluticasone regulatory update

    Vectura Group plc (LSE:VEC), Chippenham, U.K. Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland Product: AirFluSal Forspiro salmeterol/fluticasone (formerly VR315) Business: Pulmonary Novartis' Sandoz generic …

    Published on 2/17/2014
  • Anoro Ellipta umeclidinium bromide/vilanterol regulatory update

    Theravance Inc. (NASDAQ:THRX), South San Francisco, Calif. GlaxoSmithKline plc (LSE:GSK; NYSE:GSK), London, U.K. Product: Anoro Ellipta umeclidinium bromide/vilanterol (GSK573719/GSK642444) Business: Pulmonary In …

    Published on 2/17/2014
  • Botox onabotulinumtoxinA regulatory update

    Allergan Inc. (NYSE:AGN), Irvine, Calif. GlaxoSmithKline plc (LSE:GSK; NYSE:GSK), London, U.K. Product: Botox onabotulinumtoxinA (formerly botulinum toxin) Business: Musculoskeletal The U.K.'s Medicines and Healthcare …

    Published on 2/17/2014
  • Cangrelor regulatory update

    The Medicines Co. (NASDAQ:MDCO), Parsippany, N.J. AstraZeneca plc (LSE:AZN; NYSE:AZN), London, U.K. Product: Cangrelor (formerly AR-C69931MX) Business: Cardiovascular FDA's Cardiovascular and Renal Drugs Advisory …

    Published on 2/17/2014
  • Dalbavancin regulatory update

    Durata Therapeutics Inc. (NASDAQ:DRTX), Chicago, Ill. Product: Dalbavancin (RQ-00000002) Business: Infectious FDA's Anti-Infective Drugs Advisory Committee will meet on March 31 to discuss an NDA from Durata for IV …

    Published on 2/17/2014
  • DPP HIV 1/2 Assay regulatory update

    Chembio Diagnostics Inc. (NASDAQ:CEMI), Medford, N.Y. Product: DPP HIV 1/2 Assay Business: Diagnostic Chembio said it now expects a delay on a CLIA waiver application under review by FDA for its DPP HIV 1/2 Assay as an …

    Published on 2/17/2014
  • EPI-743 regulatory update

    Edison Pharmaceuticals Inc., Mountain View, Calif. Dainippon Sumitomo Pharma Co. Ltd. (Tokyo:4506), Osaka, Japan Product: EPI-743 (Vatiquinone, alpha tocotrienol quinone) Business: Neurology FDA granted Orphan Drug …

    Published on 2/17/2014
  • Flibanserin regulatory update

    Sprout Pharmaceuticals Inc., Raleigh, N.C. Product: Flibanserin (formerly BIMT-17) Business: Genitourinary Sprout said it plans to resubmit an NDA to FDA in 3Q14 for flibanserin to treat hypoactive sexual desire …

    Published on 2/17/2014
  • Fycompa perampanel regulatory update

    Eisai Co. Ltd. (Tokyo:4523), Tokyo, Japan Product: Fycompa perampanel (E2007) Business: Neurology Germany's Federal Joint Committee (G-BA) granted a request from Eisai for a new benefit assessment for Fycompa perampanel…

    Published on 2/17/2014
  • Harmony Prenatal Test regulatory update

    Ariosa Diagnostics Inc., San Jose, Calif. Product: Harmony Prenatal Test Business: Diagnostic Ariosa said the New York State Department of Health approved the Harmony Prenatal Test to detect fetal trisomies 13, 18 and …

    Published on 2/17/2014
  • Imbruvica ibrutinib regulatory update

    Pharmacyclics Inc. (NASDAQ:PCYC), Sunnyvale, Calif. Johnson & Johnson (NYSE:JNJ), New Brunswick, N.J. Product: Imbruvica ibrutinib (PCI-32765) Business: Cancer FDA granted accelerated approval to Imbruvica ibrutinib …

    Published on 2/17/2014
  • Juxtapid lomitapide regulatory update

    Aegerion Pharmaceuticals Inc. (NASDAQ:AEGR), Cambridge, Mass. Product: Juxtapid lomitapide (AEGR-733) (formerly BMS-201038) Business: Endocrine/Metabolic Aegerion said Health Canada approved Juxtapid lomitapide as an …

    Published on 2/17/2014
  • Komboglyze saxagliptin/metformin regulatory update

    Otsuka Pharmaceutical Co. Ltd., Tokyo, Japan AstraZeneca plc (LSE:AZN; NYSE:AZN), London, U.K. Product: Komboglyze saxagliptin/metformin (Kombiglyze XR) Business: Endocrine/Metabolic FDA is investigating a "possible …

    Published on 2/17/2014
  • Loutrex Topical Cream regulatory update

    Acella Pharmaceuticals LLC, Alpharetta, Ga. Product: Loutrex Topical Cream Business: Dermatology FDA granted 510(k) clearance for Acella's Loutrex Topical Cream to manage and relieve the signs and symptoms of seborrhea …

    Published on 2/17/2014
  • Meritas Troponin I test regulatory update

    Trinity Biotech plc (NASDAQ:TRIB), Dublin, Ireland Product: Meritas Troponin I test Business: Diagnostic Trinity said its Meritas Troponin I point-of-care test received CE Mark approval as an aid in diagnosing …

    Published on 2/17/2014
  • Onglyza saxagliptin regulatory update

    Otsuka Pharmaceutical Co. Ltd., Tokyo, Japan AstraZeneca plc (LSE:AZN; NYSE:AZN), London, U.K. Product: Onglyza saxagliptin (BMS-477118, OPC-262) Business: Endocrine/Metabolic FDA is investigating a "possible …

    Published on 2/17/2014
  • Opsumit macitentan regulatory update

    Actelion Ltd. (SIX:ATLN), Allschwil, Switzerland Nippon Shinyaku Co. Ltd. (Tokyo:4516), Kyoto, Japan Product: Opsumit macitentan (formerly Actelion-1, ACT-064992) Business: Cardiovascular Actelion said Australia's …

    Published on 2/17/2014
  • Pariet rabeprazole regulatory update

    Eisai Co. Ltd. (Tokyo:4523), Tokyo, Japan Product: Pariet rabeprazole (Aciphex) (E3810) Business: Gastrointestinal Eisai disclosed in its earnings for the third quarter of the fiscal year ending March 31, 2014, that it …

    Published on 2/17/2014
  • Pomalyst pomalidomide regulatory update

    Celgene Corp. (NASDAQ:CELG), Summit, N.J. Product: Pomalyst pomalidomide (CC-4047) Business: Cancer Celgene said Health Canada approved Pomalyst pomalidomide in combination with dexamethasone to treat patients with …

    Published on 2/17/2014
  • Posidur bupivacaine regulatory update

    Durect Corp. (NASDAQ:DRRX), Cupertino, Calif. Product: Posidur bupivacaine (formerly Optesia) Business: Neurology Durect said FDA issued a complete response letter for an NDA for Posidur bupivacaine to treat …

    Published on 2/17/2014
  • Quadrivalent Vaxigrip regulatory update

    Sanofi (Euronext:SAN; NYSE:SNY), Paris, France Product: Quadrivalent Vaxigrip Business: Infectious Sanofi disclosed in its 2013 earnings that it withdrew an MAA for a quadrivalent formulation of its Vaxigrip to prevent …

    Published on 2/17/2014
  • SCIB1 regulatory update

    Scancell Holdings plc (LSE:SCLP; Xetra:SCP), Nottingham, U.K. Product: SCIB1 Business: Cancer Scancell said FDA granted Orphan Drug designation to SCIB1 to treat metastatic melanoma. In December, Scancell reported data …

    Published on 2/17/2014
  • Signifor LAR pasireotide regulatory update

    Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland Product: Signifor LAR pasireotide Business: Endocrine/Metabolic Novartis disclosed in its 4Q13 earnings that it submitted regulatory applications in the U.S. and EU …

    Published on 2/17/2014
  • Sofosbuvir regulatory update

    Gilead Sciences Inc. (NASDAQ:GILD), Foster City, Calif. Product: Sofosbuvir (GS-7977)/ledipasvir (GS-5885) Business: Infectious Gilead submitted an NDA to FDA for an oral, once-daily, fixed-dose combination of the …

    Published on 2/17/2014

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