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GSK and Genmab file for Arzerra variation in Europe

04-10-2013

GlaxoSmithKline ) and partner Genmab have submitted a variation to the Marketing Authorization to the…

ArzerraBiotechnologyEuropeGenmabGlaxoSmithKlineOncologyPharmaceuticalRegulation

Positive developments for GSK's Tafinlar/Mekinist and Arzerra

16-09-2013

UK pharma giant GlaxoSmithKline (LSE: GSK) has announced positive news relating to three of its drugs,…

ArzerraBiotechnologyGenmabGlaxoSmithKlineMekinistNorth AmericaOncologyPharmaceuticalRegulationTafinlar

GlaxoSmithKline and Theravance withdraw Japan NDA for Relvar Ellipta in COPD

12-07-2013

UK pharma giant GlaxoSmithKline (LSE: GSK) and US partner Theravance (Nasdaq: THRX) revealed on Friday…

Asia-PacificBiotechnologyGlaxoSmithKlinePharmaceuticalRegulationRelvar ElliptaRespiratory and PulmonaryTheravance

GlaxoSmithKline files sNDAs for combination melanoma drugs

09-07-2013

UK pharma giant GlaxoSmithKline (LSE: GSK) said today (July 9) that it has submitted supplemental New…

BiotechnologyGlaxoSmithKlineMekinistNorth AmericaOncologyPharmaceuticalRegulationTafinlar

FDA approves Theravance and GSK's Breo Ellipta to treat COPD

13-05-2013

The US Food and Drug Administration on Friday (May 10) approved Breo Ellipta (fluticasone furoate, an…

BiotechnologyBreo ElliptaGlaxoSmithKlineNorth AmericaPharmaceuticalRegulationRespiratory and PulmonarySkyepharmaTheravance Biopharma

GlaxoSmithKline files for umeclidinium monotherapy approval in Europe

29-04-2013

UK pharma giant GlaxoSmithKline (LSE: GSK) has submitted a regulatory application in the European Union…

BiotechnologyEuropeGlaxoSmithKlinePharmaceuticalRegulationRespiratory and PulmonaryTheravanceumeclidinium

Positive NICE news for GSK's Revolade and InterMune's Esbriet

21-03-2013

UK drugs watchdog the National Institute for Health and Clinical Excellence today (March 21) issued two…

BiotechnologyEsbrietEuropeGlaxoSmithKlineImmunologicalsInterMunePharmaceuticalPricingRegulationRespiratory and PulmonaryRevolade

Regulatory updates on GSK's albiglutide, Roche's hep C test, Activartis AV0113

07-03-2013

UK pharma giant GlaxoSmithKline plc (LSE: GSK) says it has submitted a Marketing Authorization Application…

ActivartisalbiglutideAnti-viralsAV0113BiotechnologyDiabetesEperzanEuropeGlaxoSmithKlineNorth AmericaOncologyPharmaceuticalRegulationRoche

GlaxoSmithKline and Theravance file for EU approval of UMEC/VI for COPD

10-01-2013

UK pharma giant GlaxoSmithKline (LSE: GSK) and US partner Theravance (Nasdaq: THRX) yesterday submitted…

AnoroBiotechnologyEuropeGlaxoSmithKlinePharmaceuticalRegulationRespiratory and PulmonaryTheravanceUMEC/VIumeclidiniumvilanterol

Sales of antiretroviral agents for HIV will decline slightly over next decade

18-12-2012

Major-market sales of antiretroviral (ARV) agents for HIV will decline slightly over the next decade,…

Anti-viralsBiotechnologydolutegravirGenericsGlaxoSmithKlineGlobalMarkets & MarketingPharmaceuticalRegulationViiV Healthcare

Isis Pharma/GlaxoSmithKline's ISIS-TTR Rx gains US fast-track designation

14-12-2012

In what has been a busy newsflow few days for USA-based Isis Pharmaceutical (Nasdaq: ISIS), the company…

BiotechnologyGlaxoSmithKlineIsis PharmaceuticalsISIS-TTR.RXLicensingNorth AmericaPharmaceuticalRare diseasesRegulation

News briefs from Threshold, Merck KGaA and GSK

18-09-2012

US biotech firm Threshold Pharmaceuticals (Nasdaq: THLD) said yesterday that data from a Phase IIb trial…

BiotechnologyErbituxEuropeGlaxoSmithKlineMerck KGaAMerck SeronoOncologyPharmaceuticalRegulationResearchSynflorixTH-302Threshold PharmaceuticalsVaccines

US FDA clears Amarin's Vascepa, a competitor for Lovaza

30-07-2012

The US Food and Drug Administration has approved biotech firm Amarin's (Nasdaq: AMRN) Vascepa (icosapent…

AmarinBiotechnologyCardio-vascularGlaxoSmithKlineLovazaMergers & AcquisitionsNorth AmericaRegulationVascepa

News briefs: Genmab/GSK, Gilead and Mylan

24-05-2012

Denmark's Genmab (OMX: GEN) yesterday received a milestone payment of 20 million Danish kroner ($3.4…

Anti-viralsBiotechnologycobicistatFinancialGenericsGenmabGilead SciencesGlaxoSmithKlineMylan LaboratoriesOncologyRegulationViramune

Germany's IQWiG finds in favor of Yervoy but not Benlysta or Fampyra

09-05-2012

The German Institute for Quality and Efficiency in Health Care (IQWiG) in the past few days issued a…

BenlystaBiogen IdecBiotechnologyBristol-Myers SquibbEuropeFampyraGlaxoSmithKlineNeurologicalOncologyPharmaceuticalPricingRare diseasesRegulationYervoy

Roche to file for trastuzumab emtansine this year, on positive Ph III results

03-04-2012

Swiss drug major Roche (ROG: SIX) says that top-line results of EMILIA, the first randomized Phase III…

BiotechnologyGenentechGlaxoSmithKlineOncologyPharmaceuticalRegulationResearchRochetrastuzumab

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