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Chronological Index of : Regulatory

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  • Oleogel-S10 regulatory update

    Birken AG, Niefern-Oeschelbronn, Germany Product: Oleogel-S10 Business: Dermatology Birken said EMA accepted for review an MAA for Oleogel-S10 to accelerate healing in patients with partial thickness wounds. Birken …

    Published on 11/10/2014
  • Olysio simeprevir regulatory update

    Medivir AB (SSE:MVIR B), Huddinge, Sweden Johnson & Johnson (NYSE:JNJ), New Brunswick, N.J. Product: Olysio simeprevir (Galexos, Sovriad, TMC435, formerly TMC435350) Business: Infectious FDA approved the combination of …

    Published on 11/10/2014
  • Opalmon regulatory update

    Sumitomo Dainippon Pharma Co. Ltd. (Tokyo:4506), Osaka, Japan Meiji Seika Pharma Co. Ltd., Tokyo, Japan Ono Pharmaceutical Co. Ltd. (Tokyo:4528), Osaka, Japan Product: Opalmon ( Prorenal) limaprost alfadex (OP-1206) …

    Published on 11/10/2014
  • Prolaris regulatory update

    Myriad Genetics Inc. (NASDAQ:MYGN), Salt Lake City, Utah Product: Prolaris Business: Diagnostic Myriad Genetics said the National Comprehensive Cancer Network (NCCN) updated its guidelines in oncology to include …

    Published on 11/10/2014
  • Spiriva Respimat tiotropium bromide regulatory update

    Boehringer Ingelheim GmbH, Ingelheim, Germany Product: Spiriva Respimat tiotropium bromide Business: Inflammation FDA accepted for review an NDA from Boehringer for Spiriva Respimat tiotropium bromide inhalation spray …

    Published on 11/10/2014
  • Targin oxycodone/naloxone regulatory update

    Mundipharma International Ltd., Cambridge, U.K. Purdue Pharma L.P., Stamford, Conn. Product: Targin oxycodone/naloxone (Targiniq ER) Business: Neurology EMA's CHMP recommended approval of Targin oxycodone/naloxone from …

    Published on 11/10/2014
  • Tipelukast regulatory update

    MediciNova Inc. (NASDAQ:MNOV; JASDAQ:4875), San Diego, Calif. Kyorin Pharmaceutical Co. Ltd. (Tokyo:4569), Tokyo, Japan Product: Tipelukast (MN-001) (formerly KCA-757) Business: Pulmonary MediciNova said FDA granted …

    Published on 11/10/2014
  • Triferic soluble ferric pyrophosphate citrate regulatory update

    Rockwell Medical Inc. (NASDAQ:RMTI), Wixom, Mich. Product: Triferic soluble ferric pyrophosphate citrate (Soluble Ferric Pyrophosphate (SFP)) Business: Hematology Rockwell said FDA's Oncologic Drugs Advisory Committee …

    Published on 11/10/2014
  • Triheptanoin regulatory update

    Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE), Novato, Calif. Product: Triheptanoin (UX007) Business: Endocrine/Metabolic FDA granted Orphan Drug designation to triheptanoin from Ultragenyx to treat glucose transporter …

    Published on 11/10/2014
  • Trintellix vortioxetine regulatory update

    H. Lundbeck A/S (CSE:LUN), Copenhagen, Denmark Takeda Pharmaceutical Co. Ltd. (Tokyo:4502), Osaka, Japan Product: Trintellix vortioxetine (Brintellix) (formerly Lu AA21004) Business: Neurology Health Canada approved …

    Published on 11/10/2014
  • UX023 regulatory update

    Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE), Novato, Calif. Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151), Tokyo, Japan Product: UX023, KRN23 Business: Musculoskeletal The European Commission granted Orphan Drug designation …

    Published on 11/10/2014
  • Xigduo XR dapagliflozin/metformin extended-release regulatory update

    AstraZeneca plc (LSE:AZN; NYSE:AZN), London, U.K. Product: Xigduo XR dapagliflozin/metformin extended-release Business: Endocrine/Metabolic FDA approved once-daily Xigduo XR dapagliflozin/metformin extended-release …

    Published on 11/10/2014
  • Aripiprazole lauroxil regulatory update

    Alkermes plc (NASDAQ:ALKS), Dublin, Ireland Product: Aripiprazole lauroxil (ALKS 9072, ALKS 9070) Business: Neurology Alkermes said FDA accepted for review an NDA for aripiprazole lauroxil to treat schizophrenia. The …

    Published on 11/3/2014
  • Brilinta ticagrelor regulatory update

    The Medicines Co. (NASDAQ:MDCO), Parsippany, N.J. AstraZeneca plc (LSE:AZN; NYSE:AZN), London, U.K. Product: Brilinta ticagrelor (Brilique-EU) (AZD6140) Business: Cardiovascular AstraZeneca said the American Heart …

    Published on 11/3/2014
  • CardioCel regulatory update

    Admedus Ltd. (ASX:AHZ), Perth, Australia Product: CardioCel Business: Transplant Health Canada approved Admedus' CardioCel to repair congenital heart deformities and more complex heart defects. CardioCel is a …

    Published on 11/3/2014
  • Cortiment MMX budesonide regulatory update

    Cosmo Pharmaceuticals S.p.A. (SIX:COPN), Lainate, Italy Ferring Pharmaceuticals A/S, Saint-Prex, Switzerland Product: Cortiment MMX budesonide (Uceris) Business: Autoimmune Cosmo and Ferring said Cortiment MMX …

    Published on 11/3/2014
  • DTP-HepB-Polio-Hib pediatric hexavalent vaccine regulatory update

    Merck & Co. Inc. (NYSE:MRK), Whitehouse Station, N.J. Sanofi (Euronext:SAN; NYSE:SNY), Paris, France Product: DTP-HepB-Polio-Hib pediatric hexavalent vaccine (V419) Business: Infectious Merck and Sanofi's Sanofi Pasteur…

    Published on 11/3/2014
  • Empagliflozin/metformin regulatory update

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

    Published on 11/3/2014
  • Envarsus tacrolimus regulatory update

    Veloxis Pharmaceuticals A/S (CSE:VELO), Horsholm, Denmark Product: Envarsus tacrolimus (formerly LCP-Tacro) Business: Transplant Veloxis said FDA granted tentative approval to an NDA for Envarsus tacrolimus XR to …

    Published on 11/3/2014
  • Eteplirsen regulatory update

    Sarepta Therapeutics Inc. (NASDAQ:SRPT), Cambridge, Mass. Product: Eteplirsen (AVI-4658) Business: Musculoskeletal Sarepta said it would delay an NDA submission for eteplirsen to treat Duchenne muscular dystrophy (DMD) …

    Published on 11/3/2014
  • FilmArray BioThreat-E Test regulatory update

    bioMerieux S.A. (Euronext:BIM), Marcy l'Etoile, France Product: FilmArray BioThreat-E Test Business: Diagnostic FDA granted emergency use authorization (EUA) for the FilmArray BioThreat-E Test from bioMerieux's BioFire …

    Published on 11/3/2014
  • Fycompa perampanel regulatory update

    Eisai Co. Ltd. (Tokyo:4523), Tokyo, Japan Product: Fycompa perampanel (E2007) Business: Neurology Eisai said FDA accepted for review an sNDA for Fycompa perampanel for the adjunctive treatment of primary generalized …

    Published on 11/3/2014
  • Harvoni ledipasvir regulatory update

    Gilead Sciences Inc. (NASDAQ:GILD), Foster City, Calif. Product: Harvoni ledipasvir (GS-5885)/sofosbuvir (GS-7977) Business: Infectious Health Canada approved Harvoni ledipasvir/sofosbuvir from Gilead to treat chronic …

    Published on 11/3/2014
  • Keytruda pembrolizumab regulatory update

    Merck & Co. Inc. (NYSE:MRK), Whitehouse Station, N.J. Product: Keytruda pembrolizumab (MK-3475) (formerly lambrolizumab) Business: Cancer FDA granted breakthrough therapy designation to Keytruda pembrolizumab from Merck…

    Published on 11/3/2014
  • Patiromer regulatory update

    Relypsa Inc. (NASDAQ:RLYP), Redwood City, Calif. Product: Patiromer (RLY5016) Business: Endocrine/Metabolic Relypsa submitted an NDA to FDA for patiromer to treat hyperkalemia. The biotech submitted data from 8 clinical…

    Published on 11/3/2014

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