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AHF claims victory over FDA on Gilead’s PrEP


The USA-based AIDS Healthcare Foundation (AHF) says it has won another key legal victory late last week…

Anti-viralsBiotechnologyGilead SciencesLegalNorth AmericaRegulationTruvadaUSA

Mylan gets exclusive rights to distribute Gilead branded drugs in India

Mylan gets exclusive rights to distribute Gilead branded drugs in India


US generics major Mylan says its India-based subsidiary has been named) exclusive branded medicines business…

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AHF claims victory over FDA in HIV prevention drug case


The USA-based AIDS Healthcare Foundation (AHF) says it won a key legal victory in a push for drug safety…

Anti-viralsBiotechnologyGilead SciencesLegalNorth AmericaPharmaceuticalRegulationTruvada

AHF demands FDA reversal on use of Gilead's HIV prevention pill for women


Citing another failed clinical trial in women of the use of Gilead Sciences' (Nasdaq: GILD) AIDS drug…

Anti-viralsBiotechnologyGilead SciencesNorth AmericaPharmaceuticalRegulationResearchTruvada

New Zealand to fund Gilead's Atripla and Truvada


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


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


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


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


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


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


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

Anti-viralsBiotechnologycobicistatelvitegravirGilead SciencesNorth AmericaPricingQuadRegulation

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


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


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


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

Anti-viralsBiotechnologyGilead SciencesNorth AmericaPharmaceuticalRegulationTruvada

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


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


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

Anti-viralsBiotechnologyGilead SciencesNorth AmericaPharmaceuticalRegulationTruvada

New AHF ad campaign warns preventive use of Gilead AIDS drug Truvada is premature


The USA-based AIDS Healthcare Foundation (AHF) this week unveiled a new print ad that lays out data on…

Anti-viralsGilead SciencesMarkets & MarketingNorth AmericaPharmaceuticalRegulationTruvada

New research shows Gilead’s ARVs prevent HIV infection in heterosexuals


Results from two African studies of pre-exposure prophylaxis, or PrEP, released yesterday well ahead…

Anti-viralsGilead SciencesPharmaceuticalResearchTruvadaViread

Doctors tell US FDA: “HIV prevention pill” - Gilead's Truvada - not ready for approval


Last week, a group of 55 US physicians sent a letter to the Food and Drug Administration urging the agency…

Anti-viralsGilead SciencesNorth AmericaPharmaceuticalRegulationTruvada

Gilead Sciences subpoenaed in USA over HIV and other drugs


US biopharmaceutical company Gilead Sciences (Nasdaq: GILD) revealed late Friday that it has received…

Anti-viralsAtriplaBiotechnologyGilead SciencesLegalNorth AmericaPharmaceuticalTruvada

FHI to stop study of Gilead’s Truvada as HIV drug found not effective in prevention


A clinical trial by the not-for-profit organization Family Health International (FHI) designed to test…

Anti-viralsGilead SciencesPharmaceuticalRegulationResearchTruvada

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