Regulation - Gilead Sciences

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UK's NICE issues draft guideline for diagnosis and management of hepatitis B

17-01-2013

UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE) is currently developing…

Anti-viralsBaracludeBiotechnologyBristol-Myers SquibbEuropeGilead SciencesNovartisPharmaceuticalPreveonPricingRegulationSebivoViread

Japan Tobacco files for Japanese approval of elvitegravir

11-12-2012

Japan Tobacco (TSE:2914) has filed a New Drug Application for marketing approval of a novel anti-HIV…

Anti-viralsAsia-PacificBiotechnologyelvitegravirGilead SciencesJapan TobaccoPharmaceuticalRegulationTorii Pharma

New Zealand to fund Gilead's Atripla and Truvada

27-11-2012

New Zealand's Pharmaceutical Management Agency PHARMAC says that, effective December 1, it will fund…

Anti-viralsAsia-PacificAtriplaBiotechnologyFinancialGilead SciencesPharmaceuticalRegulationTruvada

Gilead HIV drugs Atripla and Truvada to be listed in New Zealand

13-11-2012

Following a consultation, New Zealand's Pharmaceutical Management Agency PHARMAC has announced the approval…

Anti-viralsAsia-PacificAtriplaBiotechnologyGilead SciencesPharmaceuticalPricingRegulationTruvada

Gilead's Truvada as HIV prevention to carry stronger FDA warning label

14-10-2012

The USA-based non-profit HIV/AIDS advocacy AIDS Healthcare Foundation (AHF) welcomed the news yesterday…

Anti-viralsBiotechnologyGilead SciencesNorth AmericaPharmaceuticalRegulationTruvada

Gilead's Stribild, formerly "Quad," gets FDA nod

29-08-2012

The US Food and Drug Administration has approved US biotech firm Gilead Sciences' (Nasdaq: GILD) Stribild…

Anti-viralsBiotechnologyGilead SciencesNorth AmericaQuadRegulationStribild

AHF calls for Gilead's Quad HIV pill to be put on "prior authorization" status

19-08-2012

In what may be an unprecedented move on drug pricing and access, advocates from the AIDS Healthcare Foundation…

Anti-viralsBiotechnologyGilead SciencesNorth AmericaPharmaceuticalPricingQuadRegulation

FDA approves Truvada, first drug for reducing the risk of sexually acquired HIV infection

17-07-2012

Despite protests from consumer groups such as the AIDS Healthcare Foundation (AHF), the US Food and Drug…

Anti-viralsBiotechnologyGilead SciencesNorth AmericaPharmaceuticalRegulationTruvada

Gilead files elvitegravir and cobicistat with FDA; AHF plea on Quad pricing

29-06-2012

US biotech firm Gilead Sciences (Nasdaq: GILD), world's largest maker of HIV drugs, has submitted a New…

Anti-viralsBiotechnologycobicistatelvitegravirGilead SciencesNorth AmericaPricingQuadRegulation

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

FDA advisory thumbs up for Gilead's once-daily Quad for HIV

14-05-2012

There was more good news for Gilead Sciences (Nasdaq: GILD), the world's largest maker of HIV drugs,…

Anti-viralsBiotechnologyGilead SciencesNorth AmericaPharmaceuticalQuadRegulation

Gilead's Quad non-inferior to Atripla for HIV; Truvada objections

08-03-2012

US biotech firm Gilead Sciences (Nasdaq: GILD) yesterday announced full Phase III clinical trial results…

Anti-viralsAtriplaBiotechnologyGilead SciencesNorth AmericaQuadRegulationResearchTruvada

US FDA priority review for Truvada for reducing HIV risk

15-02-2012

The US Food and Drug Administration has accepted the supplemental New Drug Application and granted a…

Anti-viralsBiotechnologyGilead SciencesNorth AmericaPharmaceuticalRegulationTruvada

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