Regulation - Gilead Sciences

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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

FDA backs Gilead’s Viread for children

20-01-2012

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

Anti-viralsBiotechnologyGilead SciencesNorth AmericaPharmaceuticalRegulationViread

Eisai re-submits perampanel NDA; FDA accepts Gilead’s Quad

28-12-2011

Japanese drug major Eisai (TYO: 4523) says that it has re-submitted the New Drug Application (NDA) for…

Anti-viralsEisaiGilead SciencesNeurologicalperampanelPharmaceuticalQuadRegulation

Gilead filing of Truvada for PrEP looks contentious

19-12-2011

US biotech firm Gilead Sciences’ (Nasdaq: GILD) decision last week to submit a supplemental New…

Anti-viralsBiotechnologyGilead SciencesNorth AmericaPharmaceuticalRegulationTruvada

More cancer and HIV drugs added to Australian PBS

07-12-2011

More than 160,000 patients will benefit directly from changes to Australia’s Pharmaceutical Benefits…

AmgenAnti-viralsAsia-PacificGilead SciencesOncologyPharmaceuticalPrezistaPricingRegulationXgeva

Gilead and Johnson & Johnson get EU backing for HIV drugs Eviplera and Edurant, respectively

29-11-2011

In the first of two pieces of good news for HIV/AIDS drug developers, US biotech firm Gilead Sciences…

Anti-viralsEdurantEuropeEvipleraGilead SciencesJanssen-CilagJohnson & JohnsonPharmaceuticalRegulationTibotec

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