Regulation - Anti-virals, GlaxoSmithKline

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EU marketing authorization for ViiV Healthcare HIV drug Triumeq

EU marketing authorization for ViiV Healthcare HIV drug Triumeq

03-09-2014

The European Commission has granted marketing authorization for ViiV Healthcare’s Triumeq (dolutegravir…

Anti-viralsEuropeGlaxoSmithKlinePharmaceuticalRegulationTriumeqViiV Healthcare

ViiV Healthcare gains FDA approval for HIV drug Triumeq

ViiV Healthcare gains FDA approval for HIV drug Triumeq

23-08-2014

The US Food and Drug Administration has approved Triumeq (abacavir 600mg, dolutegravir 50mg and lamivudine…

Anti-viralsGlaxoSmithKlinePfizerPharmaceuticalRegulationShionogiTriumeqUSAViiV Healthcare

IQWIG finds added benefit in adult patients for VIIV Healthcare’s Tivicay

27-05-2014

In an early benefit assessment under the Act on the Reform of the Market for Medicinal Products (AMNOG),…

Anti-viralsGermanyGlaxoSmithKlinePharmaceuticalPricingRegulationTivicayViiV Healthcare

ViiV Healthcare’s Tivicay approved in Canada for HIV

04-11-2013

ViiV Healthcare, the HIV/AIDS joint venture set up by UK pharma giant GlaxoSmithKline with US behemoth…

Anti-viralsdolutegravirGlaxoSmithKlineNorth AmericaPfizerPharmaceuticalRegulationShionogiTivicayViiV Healthcare

FDA approves new ViiV Healthcare HIV drug

13-08-2013

The US Food and Drug Administration yesterday (August 12) approved Tivicay (dolutegravir), a new drug…

Anti-viralsdolutegravirGlaxoSmithKlineNorth AmericaPfizerPharmaceuticalRegulationShionogiTivicayViiV Healthcare

US FDA approves shipment of quadrivalent flu vaccine to health care providers

06-08-2013

The US subsidiary of UK pharma giant GlaxoSmithKline (LSE: GSK) says it has received Food and Drug Administration…

Anti-viralsFluarixGlaxoSmithKlineNorth AmericaPharmaceuticalRegulationVaccines

Regulatory updates for Tris Pharma's Karbinal; GSK's four-strain seasonal flu vaccine

03-04-2013

US drug delivery specialist Tris Pharma says that the US Food and Drug Administration has approved its…

Anti-viralsEuropeFluarixGlaxoSmithKlineInflusplit TetraKarbinalNorth AmericaPharmaceuticalRegulationRespiratory and PulmonaryTris Pharma

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

Briefs: Roche deal with Chiasma; Vasella payout; FDA priority review for dolutegravir

18-02-2013

Swiss drug major Roche (ROG: SIX) has entered into an agreement to develop and commercialize privately…

Anti-viralsdolutegravirGlaxoSmithKlineLicensingManagementNovartisOctreotide AcetatePharmaceuticalRare diseasesRegulationRocheViiV Healthcare

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

Shionogi-Viiv Healthcare to start regulatory filing of dolutegravir by year-end

08-10-2012

Shionogi-ViiV Healthcare, a joint venture between Japan's Shionogi (TYO: 4507) and ViiV Healthcare, a…

Anti-viralsdolutegravirGlaxoSmithKlinePfizerPharmaceuticalRegulationResearchShionogiShionogi-ViiV HealthcareViiV Healthcare

Research news: dolutegravir; TD-1211; and synaptic modulators

11-07-2012

UK pharma giant GlaxoSmithKline (LSE: GSK) and Japanese drugmaker Shionogi (TYO: 4507) have reported…

Anti-viralsdolutegravirGalenea CorpGastro-intestinalsGlaxoSmithKlineLicensingNeurologicalPharmaceuticalRegulationResearchShionogiTD-1211TheravanceZonegran

Mylan debuts generic Epivir in Europe; gets Canadian OK for Tracleer copy

07-06-2012

US generic drugs major Mylan (Nasdaq: MYL) says that its UK and Italy-based subsidiaries have launched…

ActelionAnti-viralsEpivirEuropeGenericsGlaxoSmithKlineMarkets & MarketingMylan LaboratoriesNorth AmericaRegulationRespiratory and PulmonaryTracleer

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

EU Commission OKs Baxter Avian flu vaccine Vepacel; drops GSK probe

05-03-2012

US drugmaker Baxter International (NYSE:BAX) says that the European Commission has granted marketing…

Anti-viralsBaxter InternationalEuropeGlaxoSmithKlineLegalPharmaceuticalRegulationSynthonVaccinesVepacel

Mylan gets tentative FDA approval for generic Epzicom

23-02-2012

US generics major Mylan (Nasdaq: MYL) says that its subsidiary Mylan Laboratories has received tentative…

Anti-viralsEpzicomGenericsGlaxoSmithKlineMylan LaboratoriesNorth AmericaPfizerRegulationViiV Healthcare

US ANDAs filed for generic Beyaz, Isentress and Epivir

12-01-2012

The US Food and Drug Administration says that Abbreviated New Drug Applications have been received by…

Anti-viralsBayerBeyazEpivirGenericsGlaxoSmithKlineIsentressMerck & CoPharmaceuticalRegulationReproductive

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