Regulation - Gilead Sciences, North America

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US lawmakers question price of Gilead’s Sovaldi

US lawmakers question price of Gilead’s Sovaldi

24-03-2014

Three leading US Congressmen have written to John Martin, chief executive of US biotech firm Gilead Sciences,…

Anti-viralsBiotechnologyGilead SciencesNorth AmericaPoliticsPricingRegulationSovaldiUSA

AHF claims victory over FDA on Gilead’s PrEP

19-02-2014

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

Anti-viralsBiotechnologyGilead SciencesLegalNorth AmericaRegulationTruvadaUSA

Gilead’s Sovaldi approved in Canada for Genotypes 1, 2, 3 or 4 HCV

Gilead’s Sovaldi approved in Canada for Genotypes 1, 2, 3 or 4 HCV

16-12-2013

US antiviral biotech specialist Gilead Sciences says that Health Canada has issued a Notice of Compliance…

Anti-viralsBiotechnologyCanadaGilead SciencesNorth AmericaRegulationsofosbuvirSovaldi

US FDA backs new indication for Gilead's Complera

US FDA backs new indication for Gilead's Complera

14-12-2013

US biotech firm Gilead Sciences’ share closed up 1.6% at $71.40 on Friday, following the news of an…

Anti-viralsBiotechnologyCompleraEvipleraGilead SciencesNorth AmericaRegulation

US FDA approval for Gilead's hepatitis C drug Sovaldi

US FDA approval for Gilead's hepatitis C drug Sovaldi

08-12-2013

US antiviral biotech specialist Gilead Sciences says that the Food and Drug Administration has approved…

Anti-viralsBiotechnologyGilead SciencesNorth AmericaPricingRegulationsofosbuvirSovaldi

2013 FDA approval rates suggest record year for post-launch success

14-11-2013

A focus on hard to treat or specialist diseases is set to result in record post-launch sales for new…

Biogen IdecFinancialGilead SciencesNorth AmericaPharmaceuticalRegulationsofosbuvirTecfidera

Unanimous yes vote from FDA advisory panel for Gilead’s sofosbuvir in hep C

Unanimous yes vote from FDA advisory panel for Gilead’s sofosbuvir in hep C

27-10-2013

Following swiftly on a similar decision for Janssen’s hepatitis C drug simeprevir, the US Food and…

Anti-viralsBiotechnologyGilead SciencesNorth AmericaRegulationsofosbuvir

Gilead’s HIV drug booster Tybost gets EU marketing authorization

Gilead’s HIV drug booster Tybost gets EU marketing authorization

27-09-2013

US biotech major Gilead Sciences has received marketing authorization from the European Commission for…

Anti-viralsBiotechnologyEuropeGilead SciencesNorth AmericaRegulationTybost

Gilead files for US approval of iNHL drug candidate

12-09-2013

US biotech major Gilead Sciences (Nasdaq: GILD), best known for its prowess in antivirals (HIV and hepatitis…

BiotechnologyGilead SciencesidelalisibNorth AmericaOncologyRegulation

AHF claims victory over FDA in HIV prevention drug case

08-08-2013

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

Anti-viralsBiotechnologyGilead SciencesLegalNorth AmericaPharmaceuticalRegulationTruvada

Gilead gains FDA priority review for hep C candidate sofosbuvir; new data on Boehringer's faldaprevir

10-06-2013

US biotech firm Gilead Sciences (Nasdaq: GILD) revealed on Friday (June 7) that the US Food and Drug…

Anti-viralsAsia-PacificBiotechnologyBoehringer IngelheimfaldaprevirGilead SciencesNorth AmericaPharmaceuticalRegulationResearchsofosbuvir

US FDA delays approval of Gilead's elvitegravir and cobicistat for HIV

30-04-2013

US antiviral drug specialists Gilead Sciences (Nasdaq: GILD) says it has received Complete Response Letters…

Anti-viralsBiotechnologycobicistatelvitegravirGilead SciencesNorth AmericaRegulation

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

06-03-2013

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

Anti-viralsBiotechnologyGilead SciencesNorth AmericaPharmaceuticalRegulationResearchTruvada

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

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

Arena Pharma gets positive FDA panel vote for obesity drug; prophylactic Truvada backed

11-05-2012

USA-based Arena Pharmaceuticals (Nasdaq: ARNA) and Japanese licensing partner Eisai (TYO: 4523) got a…

Anti-viralsArena PharmaceuticalsBiotechnologyEisaiGilead ScienceslorcaserinLorquessMetabolicsNorth AmericaPharmaceuticalRegulationTruvada

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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