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Chronological Index of : Regulatory

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  • AuriPro regulatory update

    Otonomy Inc.(NASDAQ:OTIC), San Diego, Calif. Product: AuriPro (formerly OTO-201) Business: Infectious Otonomy submitted an NDA to FDA for AuriPro to treat middle ear effusion in pediatric patients undergoing …

    Published on 3/2/2015
  • Avycaz Ceftazidime/avibactam regulatory update

    Actavis plc(NYSE:ACTlksdfig), Dublin, Ireland AstraZeneca plc(LSE:AZN; NYSE:AZN), London, U.K. Product: Avycaz Ceftazidime/avibactam (CAZ-104) Business: Infectious FDA approved Avycaz ceftazidime/avibactam from Actavis …

    Published on 3/2/2015
  • Basal insulin peglispro regulatory update

    Eli Lilly and Co.(NYSE:LLY), Indianapolis, Ind. Product: Basal insulin peglispro (LY2605541) Business: Endocrine/Metabolic Eli Lilly will delay regulatory submissions to FDA and EMA for basal insulin peglispro to treat …

    Published on 3/2/2015
  • Dymista azelastine/fluticasone regulatory update

    Cipla Ltd., Mumbai, India Meda AB(SSE:MEDAA), Solna, Sweden Product: Dymista azelastine/fluticasone (MP29-02) Business: Inflammation FDA approved an sNDA from Meda for Dymista azelastine/fluticasone to treat seasonal …

    Published on 3/2/2015
  • E Keppra levetiracetam regulatory update

    UCB Group(Euronext:UCB), Brussels, Belgium Otsuka Pharmaceutical Co. Ltd., Tokyo, Japan Product: E Keppra levetiracetam (Keppra) Business: Neurology Otsuka said Japan approved an expanded label for E Keppra …

    Published on 3/2/2015
  • Farydak panobinostat regulatory update

    Novartis AG(NYSE:NVS; SIX:NOVN), Basel, Switzerland Product: Farydak panobinostat (LBH589) Business: Cancer FDA granted accelerated approval to Farydak panobinostat from Novartis in combination with Velcade bortezomib …

    Published on 3/2/2015
  • Holoclar regulatory update

    Chiesi Farmaceutici S.p.A., Parma, Italy Product: Holoclar Business: Ophthalmic Chiesi said the European Commission granted conditional approval to Holoclar to treat adults with moderate to severe limbal stem cell …

    Published on 3/2/2015
  • Kanumasebelipase alfa regulatory update

    Synageva BioPharma Corp.(NASDAQ:GEVA), Lexington, Mass. Product: Kanumasebelipase alfa (formerly SBC-102) Business: Endocrine/Metabolic Synageva said FDA accepted and granted Priority Review to a BLA for Kanuma …

    Published on 3/2/2015
  • Lonsurf trifluridine/tipiracil regulatory update

    Taiho Pharmaceutical Co. Ltd., Tokyo, Japan Product: Lonsurf trifluridine/tipiracil (TAS-102) Business: Cancer Taiho said FDA accepted for review an NDA for TAS-102 to treat refractory metastatic colorectal cancer (CRC…

    Published on 3/2/2015
  • Oncotype DX breast cancer assay regulatory update

    Genomic Health Inc.(NASDAQ:GHDX), Redwood City, Calif. Product: Oncotype DX breast cancer assay Business: Diagnostic The U.K.s NHS England and Genomic Health agreed to a patient access scheme to provide Genomic Healths …

    Published on 3/2/2015
  • Oxycodone/naltrexone regulatory update

    Pfizer Inc.(NYSE:PFE), New York, N.Y. Product: Oxycodone/naltrexone (ALO-02) Business: Neurology FDA accepted for review an NDA from Pfizer for ALO-02 to manage pain severe enough to require daily, around-the-clock, …

    Published on 3/2/2015
  • Rapamune sirolimus regulatory update

    Pfizer Inc.(NYSE:PFE), New York, N.Y. Product: Rapamune sirolimus Business: Pulmonary Pfizer said FDA accepted and granted Priority Review to an sNDA for Rapamune sirolimus to treat lymphangioleiomyomatosis. The PDUFA …

    Published on 3/2/2015
  • ReEBOV Antigen Rapid Test regulatory update

    Corgenix Medical Corp.(OTCBB:CONX), Broomfield, Colo. Product: ReEBOV Antigen Rapid Test Business: Diagnostic FDA granted emergency use authorization (EUA) for ReEBOV Antigen Rapid Test from Corgenix to detect Zaire …

    Published on 3/2/2015
  • Remsima infliximab regulatory update

    Celltrion Inc.(KOSDAQ:068270), Incheon, South Korea Nippon Kayaku Co. Ltd.(Tokyo:4272), Tokyo, Japan Product: Remsima infliximab (Inflectra) (CT-P13) Business: Autoimmune FDAs Arthritis Advisory Committee postponed a …

    Published on 3/2/2015
  • Revlimid lenalidomide regulatory update

    Celgene Corp.(NASDAQ:CELG), Summit, N.J. Product: Revlimid lenalidomide (formerly CDC 501) Business: Cancer Celgene said the European Commission approved an expanded label for Revlimid lenalidomide to include treatment …

    Published on 3/2/2015
  • Riboflavin ophthalmic solution regulatory update

    Avedro Inc., Waltham, Mass. Product: Riboflavin ophthalmic solution (VibeX) Business: Ophthalmic FDAs Dermatologic and Ophthalmic Drugs and Ophthalmic Devices Panel of the Medical Devices advisory committees voted in …

    Published on 3/2/2015
  • Rintega rindopepimut regulatory update

    Celldex Therapeutics Inc.(NASDAQ:CLDX), Needham, Mass. Product: Rintega rindopepimut (CDX-110) (formerly PF-04948568) Business: Cancer FDA granted breakthrough therapy designation to Rintega rindopepimut from Celldex to…

    Published on 3/2/2015
  • rIX-FP factor IX-albumin fusion protein regulatory update

    CSL Ltd.(ASX:CSL), Melbourne, Australia Product: rIX-FP factor IX-albumin fusion protein, (CSL654) Business: Hematology FDA accepted for review a BLA from CSLs CSL Behring subsidiary for rIX-FP for hemophilia B. CSL …

    Published on 3/2/2015
  • Sylvant siltuximab regulatory update

    Johnson & Johnson(NYSE:JNJ), New Brunswick, N.J. Product: Sylvant siltuximab (CNTO 328) Business: Cancer Germanys Federal Joint Committee (G-BA) concluded that Sylvant siltuximab from Johnson & Johnson provides added …

    Published on 3/2/2015
  • Toujeo insulin glargine regulatory update

    Sanofi(Euronext:SAN; NYSE:SNY), Paris, France Product: Toujeo insulin glargine (formerly U300) Business: Endocrine/Metabolic FDA approved once-daily Toujeo insulin glargine to improve glycemic control in Type I and II …

    Published on 3/2/2015
  • Vectibix panitumumab regulatory update

    Amgen Inc.(NASDAQ:AMGN), Thousand Oaks, Calif. Takeda Pharmaceutical Co. Ltd.(Tokyo:4502), Osaka, Japan Product: Vectibix panitumumab Business: Cancer EMAs CHMP recommended approval of an expanded label for Vectibix …

    Published on 3/2/2015
  • Veregen sinecatechins regulatory update

    Endo International plc(NASDAQ:ENDP; TSX:ENL), Dublin, Ireland Epitome Pharmaceuticals Ltd., Halifax, Nova Scotia Medigene AG(Xetra:MDG1), Martinsried, Germany Mitsui & Co. Ltd.(Tokyo:8031), Tokyo, Japan Product: Veregen…

    Published on 3/2/2015
  • 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 submitted an sBLA to FDA for…

    Published on 2/23/2015
  • Androxal enclomiphene regulatory update

    Repros Therapeutics Inc. (NASDAQ:RPRX), The Woodlands, Texas Product: Androxal enclomiphene Business: Endocrine/Metabolic Repros submitted an NDA to FDA for Androxal enclomiphene to treat secondary hypogonadism in …

    Published on 2/23/2015
  • Anyplex II HSV-1/2 Assay regulatory update

    Seegene Inc. (KOSDAQ:096530), Seoul, South Korea Product: Anyplex II HSV-1/2 Assay Business: Diagnostic FDA granted 510(k) clearance to Seegenes Anyplex II HSV-1/2 Assay to detect and type herpes simplex virus type 1 (…

    Published on 2/23/2015

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