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UK NICE recommends hepatitis C drugs Sovaldi and Olysio

UK NICE recommends hepatitis C drugs Sovaldi and Olysio

16-01-2015

In final draft guidance issued today, England health costs watchdog the National Institute for Health…

Anti-viralsBiotechnologyGilead SciencesJanssenJohnson & JohnsonOlysioPricingRegulationSovaldiUK

In 2014, FDA approved highest number of new drugs in 18 years

In 2014, FDA approved highest number of new drugs in 18 years

04-01-2015

The US Food and Drug Administration's Center for Drug Evaluation and Research approved 41 novel medicines…

AstraZenecaGilead SciencesPharmaceuticalRegulationUSA

GlaxoSmithKline files for EU extended indication for Volibris in PAH

GlaxoSmithKline files for EU extended indication for Volibris in PAH

11-12-2014

UK pharma major GlaxoSmithKline says it has filed a regulatory submission to the European Medicines Agency…

EuropeGilead SciencesGlaxoSmithKlineLetairisPharmaceuticalRegulationRespiratory and PulmonaryVolibris

France negotiates lowest price in Europe for Gilead’s Sovaldi

France negotiates lowest price in Europe for Gilead’s Sovaldi

21-11-2014

The discount negotiated by the French government on hepatitis C drug Sovaldi (sofosbuvir), produced by…

FranceGilead SciencesNephrology and HepatologyPharmaceuticalPoliticsPricingRegulationSovaldi

Gilead Sciences’ Harvoni gains EU approval

Gilead Sciences’ Harvoni gains EU approval

19-11-2014

The European Commission yesterday granted marketing authorization for US biotech antiviral specialists…

Anti-viralsBiotechnologyEuropeGilead SciencesHarvoniRegulationSovaldi

FDA approves Gilead’s Harvoni, the first combo pill for hepatitis C

FDA approves Gilead’s Harvoni, the first combo pill for hepatitis C

12-10-2014

As was largely expected, the US Food and Drug Administration on Friday approved biotech firm Gilead Sciences’…

Anti-viralsBiotechnologyGilead SciencesHarvoniPricingRegulationSovaldiUSA

Gilead files for Japanese approval of ledipasvir/sofosbuvir for hepatitis C

24-09-2014

Gilead Sciences has submitted a New Drug Application to Japan’s Pharmaceutical and Medical Devices…

Anti-viralsBiotechnologyGilead SciencesJapanledipasvirRegulationsofosbuvir

European Commission approves Gilead’s Zydelig for blood cancer

European Commission approves Gilead’s Zydelig for blood cancer

19-09-2014

The European Commission has granted marketing authorization for US biotech major Gilead Sciences’ Zydelig…

BiotechnologyEuropeGilead SciencesLymphomaMedicineOncologyRegulationZydelig

Bristol-Myers’ hep C drug Daklinza approved in Europe

Bristol-Myers’ hep C drug Daklinza approved in Europe

27-08-2014

US pharma major Bristol-Myers Squibb says that the European Commission has approved Daklinza (daclatasvir),…

Anti-viralsBristol-Myers SquibbDaklinzaEuropeGilead SciencesPharmaceuticalRegulationSovaldi

Positive draft guidance for hep C drug Sovaldi from UK’s NICE

Positive draft guidance for hep C drug Sovaldi from UK’s NICE

15-08-2014

In further draft guidance published today, UK drugs watchdog the National Institute for Health and Care…

Anti-viralsBiotechnologyGilead SciencesHepatitis CPricingRegulationRibavirinSovaldiUK

EMA’s CHMP backs approval of two new treatment options for rare cancers

EMA’s CHMP backs approval of two new treatment options for rare cancers

26-07-2014

The European Medicines Agency's Committee for Medicinal Products for Human Use, at its July meeting,…

BiotechnologyEuropeFinancialGilead SciencesImbruvicaJanssen BiotechJohnson & JohnsonOncologyRegulationZydelig

US FDA approves Gilead’s Zydelig for three types of blood cancers

US FDA approves Gilead’s Zydelig for three types of blood cancers

24-07-2014

The US Food and Drug Administration late yesterday approved Zydelig (idelalisib), a new drug from US…

BiotechnologyGilead SciencesidelalisibOncologyRegulationUSAZydelig

Australia’s TGA clears the way for Gilead’s Sovaldi for hepatitis C

Australia’s TGA clears the way for Gilead’s Sovaldi for hepatitis C

08-07-2014

Australian health care regulator the Therapeutic Goods Administration (TGA) has approved the use of US…

Anti-viralsAustraliaBiotechnologyGilead SciencesRegulationSovaldi

Gilead submits for approval of hepatitis C drug Sovaldi in Japan

Gilead submits for approval of hepatitis C drug Sovaldi in Japan

27-06-2014

US biotech firm Gilead Sciences revealed this morning it has submitted a New Drug Application to Japan's…

Anti-viralsBiotechnologyGilead SciencesJapanRegulationSovaldi

Gilead’s ledipasvir/sofosbuvir achieved 100% SVR12 among chronic hepatitis C patients in Japan

Gilead’s ledipasvir/sofosbuvir achieved 100% SVR12 among chronic hepatitis C patients in Japan

16-06-2014

US anti-virals major Gilead Sciences has released strong top-line results from a Phase III clinical trial…

Anti-viralsBiotechnologyGilead SciencesJapanledipasvirRegulationResearchsofosbuvirSovaldi

UK NICE consults on draft guidance for Gilead’s hepatitis C drug Sovaldi

UK NICE consults on draft guidance for Gilead’s hepatitis C drug Sovaldi

16-06-2014

In draft recommendations published today, UK health care watchdog the National Institute for Health and…

Anti-viralsBiotechnologyGilead SciencesPricingRegulationSovaldiUK

French Transparency agency backs Gilead’s new hepatitis C drug Sovaldi

French Transparency agency backs Gilead’s new hepatitis C drug Sovaldi

09-06-2014

There was good news for US antivirals major Gilead Sciences, when France’s health technology assessment…

Anti-viralsBiotechnologyFranceGilead SciencesPricingRegulationSovaldi

Janssen submits sNDA for Olysio in combination with sofosbuvir

Janssen submits sNDA for Olysio in combination with sofosbuvir

08-05-2014

Janssen Research & Development, a subsidiary of US health care giant Johnson & Johnson, has submitted…

Anti-viralsBiotechnologyGilead SciencesJanssenJohnson & JohnsonOlysioRegulationSovaldiUSA

FDA priority review for Gilead’s ledipasvir/sofosbuvir fixed-dose combo for hepatitis C

FDA priority review for Gilead’s ledipasvir/sofosbuvir fixed-dose combo for hepatitis C

08-04-2014

US anti-virals major Gilead Sciences says that the US Food and Drug Administration has granted priority…

Anti-viralsBiotechnologyGilead SciencesledipasvirNorth AmericaRegulationsofosbuvirUSA

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

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

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