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Chronological Index of : Regulatory

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  • 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
  • Asfotase alfa regulatory update

    Alexion Pharmaceuticals Inc. (NASDAQ:ALXN), Cheshire, Conn. Product: Asfotase alfa (ENB-0040) Business: Endocrine/Metabolic Alexion completed submission of a rolling BLA to FDA for asfotase alfa to treat …

    Published on 1/19/2015
  • Ceftazidime/avibactam regulatory update

    Actavis plc (NYSE:ACT), Dublin, Ireland AstraZeneca plc (LSE:AZN; NYSE:AZN), London, U.K. Product: Ceftazidime/avibactam (CAZ AVI, CAZ-104, CAZ104) (formerly NXL104/ceftazidime) Business: Infectious Actavis said FDAs …

    Published on 1/19/2015
  • Copaxone glatiramer acetate regulatory update

    Teva Pharmaceutical Industries Ltd. (NYSE:TEVA), Petah Tikva, Israel Sanofi (Euronext:SAN; NYSE:SNY), Paris, France Product: Copaxone glatiramer acetate Business: Autoimmune Teva said thrice-weekly 40 mg Copaxone …

    Published on 1/19/2015
  • Denosumab regulatory update

    Amgen Inc. (NASDAQ:AMGN), Thousand Oaks, Calif. Daiichi Sankyo Co. Ltd. (Tokyo:4568), Tokyo, Japan Product: Denosumab (Prolia, Xgeva, Ranmark) (AMG 162) Business: Musculoskeletal FDA approved Xgeva denosumab from Amgen …

    Published on 1/19/2015
  • Dyloject diclofenac sodium regulatory update

    Hospira Inc. (NYSE:HSP), Lake Forest, Ill. Product: Dyloject diclofenac sodium Business: Neurology FDA approved an NDA from Hospira for IV Dyloject diclofenac to manage moderate to severe pain alone or in combination …

    Published on 1/19/2015
  • Exviera dasabuvir regulatory update

    AbbVie Inc. (NYSE:ABBV), Chicago, Ill. Product: Exviera dasabuvir (ABT-333) Business: Infectious Enanta Pharmaceuticals Inc. (NASDAQ:ENTA, Watertown, Mass.) and AbbVie said the European Commission approved an all-oral, …

    Published on 1/19/2015
  • 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 assigned an April 17 PDUFA date to an sNDA from …

    Published on 1/19/2015
  • Maestro Rechargeable regulatory update

    EnteroMedics Inc. (NASDAQ:ETRM), St. Paul, Minn. Product: Maestro Rechargeable (RC) System Business: Endocrine/Metabolic FDA approved EnteroMedics VBLOC vagal blocking therapy on the Maestro RC System to treat obesity …

    Published on 1/19/2015
  • Movantik naloxegol regulatory update

    Nektar Therapeutics (NASDAQ:NKTR), San Francisco, Calif. AstraZeneca plc (LSE:AZN; NYSE:AZN), London, U.K. Product: Movantik naloxegol (Moventig) (formerly NKTR-118) Business: Gastrointestinal The European Commission …

    Published on 1/19/2015
  • Neutrolin regulatory update

    CorMedix Inc. (NYSE-M:CRMD), Summit, N.J. Product: Neutrolin (CRMD003) Business: Infectious Germany approved a label expansion for Neutrolin catheter lock solution from CorMedix to include use in oncology patients …

    Published on 1/19/2015
  • Opdivo nivolumab regulatory update

    Ono Pharmaceutical Co. Ltd. (Tokyo:4528), Osaka, Japan Bristol-Myers Squibb Co. (NYSE:BMY), New York, N.Y. Product: Opdivo nivolumab (ONO-4538, MDX-1106, BMS-936558) Business: Cancer Bristol-Myers completed submission …

    Published on 1/19/2015
  • Praluent alirocumab regulatory update

    Regeneron Pharmaceuticals Inc. (NASDAQ:REGN), Tarrytown, N.Y. Sanofi (Euronext:SAN; NYSE:SNY), Paris, France Product: Praluent alirocumab (SAR236553, REGN727) Business: Endocrine/Metabolic Regeneron and Sanofi said EMA …

    Published on 1/19/2015
  • Prosigna Breast Cancer Prognostic Gene Signature Assay regulatory update

    NanoString Technologies Inc. (NASDAQ:NSTG), Seattle, Wash. Product: Prosigna Breast Cancer Prognostic Gene Signature Assay (PAM50-based gene expression test for breast cancer) Business: Diagnostic FDA approved an …

    Published on 1/19/2015
  • Retacrit epoetin zeta regulatory update

    Hospira Inc. (NYSE:HSP), Lake Forest, Ill. Stada Arzneimittel AG (Xetra:SAZ), Bad Vilbel, Germany Product: Retacrit epoetin zeta Business: Hematology Hospira submitted a BLA to FDA for Retacrit epoetin zeta, a …

    Published on 1/19/2015
  • Soolantra ivermectin 1% regulatory update

    Galderma S.A., Lausanne, Switzerland Product: Soolantra ivermectin 1% (CD5024 1%) Business: Dermatology FDA approved an NDA for once-daily Soolantra ivermectin 1% cream from Galderma to treat inflammatory lesions of …

    Published on 1/19/2015
  • Sovaldi sofosbuvir regulatory update

    Gilead Sciences Inc. (NASDAQ:GILD), Foster City, Calif. Product: Sovaldi sofosbuvir (GS-7977) (formerly PSI-7977) Business: Infectious The U.K.s NICE issued final draft guidance for Sovaldi sofosbuvir in combination …

    Published on 1/19/2015
  • Stelara ustekinumab regulatory update

    Bristol-Myers Squibb Co. (NYSE:BMY), New York, N.Y. Johnson & Johnson (NYSE:JNJ), New Brunswick, N.J. Product: Stelara ustekinumab (CNTO 1275) Business: Autoimmune The U.K.s NICE issued draft guidance recommending …

    Published on 1/19/2015
  • Viekirax paritaprevir regulatory update

    Enanta Pharmaceuticals Inc. (NASDAQ:ENTA), Watertown, Mass. AbbVie Inc. (NYSE:ABBV), Chicago, Ill. Product: Viekirax paritaprevir (ABT-450) plus ritonavir/ombitasvir (ABT-267) Business: Infectious Enanta and AbbVie …

    Published on 1/19/2015
  • Xeloda capecitabine regulatory update

    Chugai Pharmaceutical Co. Ltd. (Tokyo:4519), Tokyo, Japan Roche (SIX:ROG; OTCQX:RHHBY), Basel, Switzerland Product: Xeloda capecitabine (R340, RG340) Business: Cancer Chugai submitted a regulatory application in Japan …

    Published on 1/19/2015
  • Xiaflex collagenase clostridium histolyticum regulatory update

    Auxilium Pharmaceuticals Inc. (NASDAQ:AUXL), Chesterbrook, Pa. BioSpecifics Technologies Corp. (NASDAQ:BSTC), Lynbrook, N.Y. Swedish Orphan Biovitrum AB (SSE:SOBI), Stockholm, Sweden Asahi Kasei Pharma Corp., Tokyo, …

    Published on 1/19/2015
  • Carmeseal-MD regulatory update

    Phrixus Pharmaceuticals Inc., Ann Arbor, Mich. Product: Carmeseal-MD (subcutaneous poloxamer 188) Business: Musculoskeletal Phrixus and Ethicor Pharma Ltd. (London, U.K.) will begin a European access program this month …

    Published on 1/12/2015
  • 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 Health Canada approved Eylea …

    Published on 1/12/2015

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