Skip to main content
Home > Week in Review > Regulatory

Chronological Index of : Regulatory

 Current Issue
  • AG-348 regulatory update

    Agios Pharmaceuticals Inc. (NASDAQ:AGIO), Cambridge, Mass. Product: AG-348 Business: Endocrine/Metabolic Agios said FDA granted Orphan Drug designation to AG-348 to treat pyruvate kinase deficiency. This half, the …

    Published on 3/30/2015
  • Akynzeo netupitant/palonosetron regulatory update

    Helsinn Healthcare S.A., Lugano, Switzerland Sinclair IS Pharma plc (LSE:SPH), London, U.K. Taiho Pharmaceutical Co. Ltd., Tokyo, Japan Product: Akynzeo netupitant/palonosetron (NEPA) (formerly Netu-palo-FDC) Business: …

    Published on 3/30/2015
  • Anthrasil anthrax immune globulin IV regulatory update

    Emergent BioSolutions Inc. (NYSE:EBS), Rockville, Md. Product: Anthrasil anthrax immune globulin IV (AIGIV, Anthrivig) Business: Infectious FDA approved a BLA from Emergent for Anthrasil anthrax immune globulin IV (…

    Published on 3/30/2015
  • Bridion sugammadex regulatory update

    Merck & Co. Inc. (NYSE:MRK), Whitehouse Station, N.J. Product: Bridion sugammadex (MK-8616) (formerly Org 25969, SCH 900616) Business: Neurology FDA cancelled the March 18 meeting of its Anesthetic and Analgesic Drug …

    Published on 3/30/2015
  • Daklinza daclatasvir regulatory update

    Bristol-Myers Squibb Co. (NYSE:BMY), New York, N.Y. Product: Daklinza daclatasvir (BMS-790052) Business: Infectious FDA accepted for review a resubmitted NDA for Daklinza daclatasvir from Bristol-Myers Squibb in …

    Published on 3/30/2015
  • Eylea aflibercept ophthalmic solution regulatory update

    Regeneron Pharmaceuticals Inc. (NASDAQ:REGN), Tarrytown, N.Y. Bayer AG (Xetra:BAYN), Leverkusen, Germany Product: Eylea aflibercept ophthalmic solution (VEGF Trap-Eye) Business: Ophthalmic FDA approved an sBLA from …

    Published on 3/30/2015
  • Firdapse amifampridine regulatory update

    BioMarin Pharmaceutical Inc. (NASDAQ:BMRN), Novato, Calif. Catalyst Pharmaceutical Partners Inc. (NASDAQ:CPRX), Coral Gables, Fla. Jazz Pharmaceuticals plc (NASDAQ:JAZZ), Dublin, Ireland Product: Firdapse amifampridine …

    Published on 3/30/2015
  • FlowScript HPV E6/E7 regulatory update

    Enzo Biochem Inc. (NYSE:ENZ), Farmingdale, N.Y. Product: FlowScript HPV E6/E7 Business: Diagnostic Enzo said the New York State Department of Health approved the companys FlowScript HPV E6/E7 assay to detect HPV …

    Published on 3/30/2015
  • Gardasil 9 regulatory update

    Merck & Co. Inc. (NYSE:MRK), Whitehouse Station, N.J. Product: Gardasil 9 Business: Infectious EMAs CHMP recommended approval of Gardasil 9 to prevent cancers caused by 9 HPV types in children ages >=9. Specifically,…

    Published on 3/30/2015
  • Glassia regulatory update

    Kamada Ltd. (Tel Aviv:KMDA; NASDAQ:KMDA), Ness Ziona, Israel Product: Glassia (IV Alpha-1 Antitrypsin (AAT)) Business: Transplant Kamada said the European Commission granted Orphan Drug designation to Glassia to treat …

    Published on 3/30/2015
  • Kovaltry regulatory update

    Bayer AG (Xetra:BAYN), Leverkusen, Germany Product: Kovaltry (BAY 81-8973) Business: Hematology Bayer said FDA accepted for review a BLA for Kovaltry to treat hemophilia A in children and adults. Bayer did not disclose …

    Published on 3/30/2015
  • Lenvima lenvatinib regulatory update

    Eisai Co. Ltd. (Tokyo:4523), Tokyo, Japan SFJ Pharmaceuticals Inc., Pleasanton, Calif. Product: Lenvima lenvatinib (E7080) Business: Cancer Japan granted approval and EMAs CHMP recommended approval of Lenvima lenvatinib…

    Published on 3/30/2015
  • Lonsurf trifluridine/tipiracil regulatory update

    Taiho Pharmaceutical Co. Ltd., Tokyo, Japan Product: Lonsurf trifluridine/tipiracil (TAS-102) Business: Cancer Japan approved an expanded label for Lonsurf trifluridine/tipiracil from Taiho for unresectable advanced or …

    Published on 3/30/2015
  • Prevenar 13 regulatory update

    Pfizer Inc. (NYSE:PFE), New York, N.Y. Product: Prevenar 13 (Prevnar 13, 13vPNC, PCV13)) Business: Infectious Pfizer said the European Commission approved an expanded label for Prevenar 13 in adults to include the …

    Published on 3/30/2015
  • Remitch nalfurafine regulatory update

    Mitsubishi Tanabe Pharma Corp. (Tokyo:4508), Osaka, Japan Toray Industries Inc. (Tokyo:3402), Tokyo, Japan Product: Remitch nalfurafine (Winfuran) (MT-9938, TRK-820) Business: Dermatology Toray submitted a regulatory …

    Published on 3/30/2015
  • Saphris asenapine regulatory update

    Merck & Co. Inc. (NYSE:MRK), Whitehouse Station, N.J. Product: Saphris asenapine (ME2136, SCH 900274) Business: Neurology FDA approved Saphris asenapine from Merck to treat manic or mixed episodes associated with …

    Published on 3/30/2015
  • Saxenda liraglutide 3 mg regulatory update

    Novo Nordisk A/S (CSE:NVO; NYSE:NVO), Bagsvaerd, Denmark Product: Saxenda liraglutide 3 mg (NN8022) Business: Endocrine/Metabolic The European Commission approved an MAA from Novo Nordisk for Saxenda liraglutide for …

    Published on 3/30/2015
  • Sovaldi sofosbuvir regulatory update

    Gilead Sciences Inc. (NASDAQ:GILD), Foster City, Calif. Product: Sovaldi sofosbuvir (GS-7977) (formerly PSI-7977) Business: Infectious Hetero Drugs Ltd. (Hyderabad, India) said the Drug Controller General of India (DCGI…

    Published on 3/30/2015
  • Sovaldi sofosbuvir regulatory update

    Gilead Sciences Inc. (NASDAQ:GILD), Foster City, Calif. Product: Sovaldi sofosbuvir (GS-7977) (formerly PSI-7977) Business: Infectious Gilead said Japans Ministry of Health, Labor and Welfare (MHLW) approved an NDA for …

    Published on 3/30/2015
  • Synjardy empagliflozin/metformin regulatory update

    Boehringer Ingelheim GmbH, Ingelheim, Germany Eli Lilly and Co. (NYSE:LLY), Indianapolis, Ind. Product: Synjardy empagliflozin/metformin Business: Endocrine/Metabolic EMAs CHMP recommended approval of Synjardy …

    Published on 3/30/2015
  • Yervoy ipilimumab regulatory update

    Ono Pharmaceutical Co. Ltd. (Tokyo:4528), Osaka, Japan Bristol-Myers Squibb Co. (NYSE:BMY), New York, N.Y. Product: Yervoy ipilimumab (BMS-734016) Business: Cancer Bristol-Myers Squibb said FDA accepted for review an …

    Published on 3/30/2015
  • Adempas riociguat regulatory update

    Bayer AG (Xetra:BAYN), Leverkusen, Germany Merck & Co. Inc. (NYSE:MRK), Whitehouse Station, N.J. Product: Adempas riociguat (BAY 63-2521) Business: Cardiovascular Bayer said Japan approved a regulatory application to …

    Published on 3/23/2015
  • Aricept donepezil regulatory update

    Eisai Co. Ltd. (Tokyo:4523), Tokyo, Japan Pfizer Inc. (NYSE:PFE), New York, N.Y. Product: Aricept donepezil Business: Neurology Eisai said the China Food and Drug Administration (CFDA) accepted for review an NDA to …

    Published on 3/23/2015
  • Arzerra ofatumumab regulatory update

    Genmab A/S (CSE:GEN; OTCBB:GMXAY), Copenhagen, Denmark Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland Product: Arzerra ofatumumab (HuMax-CD20) Business: Cancer The U.K.s NICE issued a final appraisal determination…

    Published on 3/23/2015
  • Breo Ellipta fluticasone furoate/vilanterol regulatory update

    Theravance Inc. (NASDAQ:THRX), South San Francisco, Calif. GlaxoSmithKline plc (LSE:GSK; NYSE:GSK), London, U.K. Product: Breo Ellipta fluticasone furoate/vilanterol (Relvar-EU) (Relvar/Breo) (GW685698/GW64244) (…

    Published on 3/23/2015

< Previous   1  2  3  4  5  Next >
Subscribe Now
Free Trial

About BioCentury

Decision-shaping business intelligence for the global biotech and pharma industry since 1993