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Germany’s IQWiG views Xofigo, Kadcyla and Eviplera

03-04-2014

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

Anti-viralsBayerEvipleraGermanyGilead SciencesKadcylaNorthern EuropeOncologyPharmaceuticalPricingRegulationRocheXofigo

Breakthrough year for unmet diseases, as FDA backs 37 designations in 2013

Breakthrough year for unmet diseases, as FDA backs 37 designations in 2013

17-01-2014

Since the US Food and Drug Administration’s breakthrough therapy designation (BTD) was put into effect…

GazyvaGilead SciencesImbruvicaJohnson & JohnsonPharmaceuticalRegulationRocheSovaldiUSA

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

EMA advises on compassionate use of sofosbuvir for hepatitis C

EMA advises on compassionate use of sofosbuvir for hepatitis C

25-10-2013

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has given an…

Anti-viralsEuropeGilead SciencesPharmaceuticalRegulationsofosbuvir

Janssen-Cilag files European approval of combination medicine for HIV-1

16-10-2013

US health care giant Johnson & Johnson subsidiary Janssen-Cilag International NV has submitted a Marketing…

Anti-viralsBiotechnologycobicistatDarunavirEuropeGilead SciencesJanssen-CilagJohnson & JohnsonPharmaceuticalRegulation

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

AstraZeneca's naloxegol meets endpoints; EMA validates Gilead's sofosbuvir MAA

22-05-2013

Anglo-Swedish drug major AstraZeneca (LSE: AZN) yesterday (May 21) presented the results of two pivotal…

Anti-viralsAstraZenecaBiotechnologyEuropeGastro-intestinalsGilead SciencesnaloxegolNektar TherapeuticsPharmaceuticalRegulationResearchsofosbuvir

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

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

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

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

1 to 25 of 35 results

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