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Chronological Index of : Regulatory

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  • Architect Clinical Chemistry Hemoglobin A1c regulatory update

    Abbott Laboratories (NYSE:ABT), Abbott Park, Ill. Product: Architect Clinical Chemistry Hemoglobin A1c (HbA1c) test Business: Diagnostic FDA granted 510(k) clearance for Abbott's Architect Clinical Chemistry HbA1c test …

    Published on 4/21/2014
  • Arzerra ofatumumab regulatory update

    Genmab A/S (CSE:GEN; OTCBB:GMXAY), Copenhagen, Denmark GlaxoSmithKline plc (LSE:GSK; NYSE:GSK), London, U.K. Product: Arzerra ofatumumab (HuMax-CD20) Business: Cancer FDA approved an sBLA from GlaxoSmithKline expanding …

    Published on 4/21/2014
  • Atazanavir/cobicistat regulatory update

    Gilead Sciences Inc. (NASDAQ:GILD), Foster City, Calif. Bristol-Myers Squibb Co. (NYSE:BMY), New York, N.Y. Product: Atazanavir/cobicistat Business: Infectious Bristol-Myers Squibb submitted an NDA to FDA for a fixed-…

    Published on 4/21/2014
  • BRACAnalysis regulatory update

    Myriad Genetics Inc. (NASDAQ:MYGN), Salt Lake City, Utah Product: BRACAnalysis Business: Diagnostic Myriad submitted to FDA the first of 4 modules of a PMA for its BRACAnalysis test as a companion diagnostic for …

    Published on 4/21/2014
  • Bufomix Easyhaler budesonide/formoterol regulatory update

    Orion Corp. (HSE:ORNAV; HSE:ORNBV), Espoo, Finland Product: Bufomix Easyhaler budesonide/formoterol Business: Inflammation Orion said Ireland and Hungary approved its Bufomix Easyhaler budesonide/formoterol to treat …

    Published on 4/21/2014
  • Constella linaclotide regulatory update

    Almirall S.A. (Madrid:ALM), Barcelona, Spain Ironwood Pharmaceuticals Inc. (NASDAQ:IRWD), Cambridge, Mass. Astellas Pharma Inc. (Tokyo:4503), Tokyo, Japan Forest Laboratories Inc. (NYSE:FRX), New York, N.Y. AstraZeneca …

    Published on 4/21/2014
  • Empagliflozin/linagliptin regulatory update

    Boehringer Ingelheim GmbH, Ingelheim, Germany Eli Lilly and Co. (NYSE:LLY), Indianapolis, Ind. Product: Empagliflozin/linagliptin Business: Endocrine/Metabolic Boehringer and Eli Lilly said FDA accepted for review an …

    Published on 4/21/2014
  • Firmagon degarelix regulatory update

    Astellas Pharma Inc. (Tokyo:4503), Tokyo, Japan Ferring Pharmaceuticals A/S, Saint-Prex, Switzerland Product: Firmagon degarelix (Gonax) (ASP3550) Business: Cancer The U.K.'s NICE issued a final appraisal determination…

    Published on 4/21/2014
  • Grastek grass pollen Allergy Immunotherapy Tablet regulatory update

    ALK-Abello A/S (CSE:ALK-B), Horsholm, Denmark Merck & Co. Inc. (NYSE:MRK), Whitehouse Station, N.J. Product: Grastek grass pollen Allergy Immunotherapy Tablet (AIT) (Grazax) (MK-7243) Business: Inflammation FDA approved…

    Published on 4/21/2014
  • Iluvien fluocinolone acetonide intravitreal implant regulatory update

    Alimera Sciences Inc. (NASDAQ:ALIM), Alpharetta, Ga. pSivida Corp. (NASDAQ:PSDV; ASX:PVA), Watertown, Mass. Product: Iluvien fluocinolone acetonide intravitreal implant (formerly Medidur FA) Business: Ophthalmic Alimera…

    Published on 4/21/2014
  • Kuvan sapropterin dihydrochloride regulatory update

    BioMarin Pharmaceutical Inc. (NASDAQ:BMRN), Novato, Calif. Daiichi Sankyo Co. Ltd. (Tokyo:4568), Tokyo, Japan Merck KGaA (Xetra:MRK), Darmstadt, Germany Product: Kuvan sapropterin dihydrochloride (6R-BH4) Business: …

    Published on 4/21/2014
  • Lipiodol ethiodized oil regulatory update

    Guerbet S.A. (Euronext:GBT), Villepinte, France Product: Lipiodol ethiodized oil Business: Diagnostic FDA approved an sNDA from Guerbet for Lipiodol ethiodized oil for selective hepatic intra-arterial use for imaging …

    Published on 4/21/2014
  • Nerixia neridronic acid regulatory update

    Abiogen Pharma S.p.A., Pisa, Italy Product: Nerixia neridronic acid Business: Musculoskeletal Abiogen and Clinigen Group Ltd. (Burton-on-Trent, U.K.) announced the start of a named-patient program in the EU to provide …

    Published on 4/21/2014
  • NovoEight turoctocog alfa regulatory update

    Novo Nordisk A/S (CSE:NVO; NYSE:NVO), Bagsvaerd, Denmark Product: NovoEight turoctocog alfa (Novoeight, recombinant FVIII) (NN7008) Business: Hematology Germany's Institute for Quality and Efficiency in Healthcare (…

    Published on 4/21/2014
  • Olaparib regulatory update

    AstraZeneca plc (LSE:AZN; NYSE:AZN), London, U.K. Product: Olaparib (AZD2281, KU-0059436) Business: Cancer FDA's Oncologic Drugs Advisory Committee will meet on June 25 to discuss an NDA from AstraZeneca for olaparib as…

    Published on 4/21/2014
  • Ragwitek ragweed Allergy Immunotherapy Tablet regulatory update

    ALK-Abello A/S (CSE:ALK-B), Horsholm, Denmark Merck & Co. Inc. (NYSE:MRK), Whitehouse Station, N.J. Product: Ragwitek ragweed Allergy Immunotherapy Tablet (AIT) (MK-3641) (formerly SCH 039641) Business: Inflammation FDA…

    Published on 4/21/2014
  • ReCell Spray-on-Skin regulatory update

    Avita Medical Ltd. (ASX:AVH), Perth, Australia Product: ReCell Spray-on-Skin Business: Dermatology Avita said FDA granted an investigational device exemption (IDE) for ReCell Spray-on-Skin for use in up to 12 patients …

    Published on 4/21/2014
  • Sovaldi sofosbuvir regulatory update

    Gilead Sciences Inc. (NASDAQ:GILD), Foster City, Calif. Product: Sovaldi sofosbuvir (GS-7977) (formerly PSI-7977) Business: Infectious NHS England approved 18.7 million ($31.3 million) in funding to treat patients with …

    Published on 4/21/2014
  • Tanzeum albiglutide regulatory update

    GlaxoSmithKline plc (LSE:GSK; NYSE:GSK), London, U.K. Product: Tanzeum albiglutide (Eperzan) Business: Endocrine/Metabolic FDA approved Tanzeum albiglutide from GlaxoSmithKline to treat Type II diabetes as monotherapy …

    Published on 4/21/2014
  • Trobalt retigabine regulatory update

    Valeant Pharmaceuticals International Inc. (TSX:VRX; NYSE:VRX), Montreal, Quebec Meda AB (SSE:MEDAA), Solna, Sweden GlaxoSmithKline plc (LSE:GSK; NYSE:GSK), London, U.K. Product: Trobalt retigabine (Potiga, ezogabine) …

    Published on 4/21/2014
  • Volasertib regulatory update

    Boehringer Ingelheim GmbH, Ingelheim, Germany Product: Volasertib (BI 6727) Business: Cancer The European Commission and FDA granted Orphan Drug designation to Boehringer's volasertib to treat acute myelogenous leukemia…

    Published on 4/21/2014
  • Aclidinium bromide/formoterol fumarate regulatory update

    Almirall S.A. (Madrid:ALM), Barcelona, Spain Forest Laboratories Inc. (NYSE:FRX), New York, N.Y. Kyorin Pharmaceutical Co. Ltd. (Tokyo:4569), Tokyo, Japan Product: Aclidinium bromide/formoterol fumarate (KRP-AB1102F, …

    Published on 4/14/2014
  • Afrezza regulatory update

    MannKind Corp. (NASDAQ:MNKD), Valencia, Calif. Product: Afrezza (formerly Afresa) Business: Endocrine/Metabolic MannKind said FDA extended by 3 months the PDUFA date for a resubmitted NDA for Afrezza to improve glycemic…

    Published on 4/14/2014
  • Asunaprevir regulatory update

    Bristol-Myers Squibb Co. (NYSE:BMY), New York, N.Y. Product: Asunaprevir (BMS-650032) Business: Infectious Bristol-Myers submitted a pair of NDAs to FDA for daclatasvir (BMS-790052) and asunaprevir to treat HCV genotype…

    Published on 4/14/2014
  • Bexsero regulatory update

    Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland Product: Bexsero Business: Infectious Novartis said FDA granted breakthrough therapy designation for Bexsero meningitis B vaccine. The pharma said it plans to submit …

    Published on 4/14/2014

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