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Added benefit for certain patients found by IQWiG with Janssen’s Olysio

Added benefit for certain patients found by IQWiG with Janssen’s Olysio

15-09-2014

In an early benefit assessment pursuant to the Act on the Reform of the Market for Medicinal Products…

Anti-viralsGermanyJanssenJohnson & JohnsonOlysioPharmaceuticalPricingRegulation

EU marketing authorization for ViiV Healthcare HIV drug Triumeq

EU marketing authorization for ViiV Healthcare HIV drug Triumeq

03-09-2014

The European Commission has granted marketing authorization for ViiV Healthcare’s Triumeq (dolutegravir…

Anti-viralsEuropeGlaxoSmithKlinePharmaceuticalRegulationTriumeqViiV Healthcare

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

ViiV Healthcare gains FDA approval for HIV drug Triumeq

ViiV Healthcare gains FDA approval for HIV drug Triumeq

23-08-2014

The US Food and Drug Administration has approved Triumeq (abacavir 600mg, dolutegravir 50mg and lamivudine…

Anti-viralsGlaxoSmithKlinePfizerPharmaceuticalRegulationShionogiTriumeqUSAViiV Healthcare

Positive draft guidance for hep C drug Sovaldi from UK’s NICE

Positive draft guidance for hep C drug Sovaldi from UK’s NICE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In further draft guidance published today, UK drugs watchdog the National Institute for Health and Care…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

Ethical considerations for use of unregistered interventions for Ebola viral disease

Ethical considerations for use of unregistered interventions for Ebola viral disease

12-08-2014

In reaction to West Africa is experiencing the largest, most severe and most complex outbreak of Ebola…

Anti-viralsClinical researchHealthcarePharmaceuticalRegulationRest of the WorldTropical diseases

FDA modifies Tekmira's TKM-Ebola clinical hold to partial hold

FDA modifies Tekmira's TKM-Ebola clinical hold to partial hold

08-08-2014

Canadian RNA interference (RNAi) therapeutics developer Tekmira Pharmaceuticals revealed yesterday that…

Anti-viralsEbolaMicrobiologyPharmaceuticalRegulationResearchTekmira PharmaceuticalsTKM-EbolaUS Food and Drug AdministrationUSA

Antiviral gel in condoms to kill HIV approved in Australia

Antiviral gel in condoms to kill HIV approved in Australia

28-07-2014

Australian biotech firm Starpharma says it has achieved a major milestone with the receipt of Conformity…

AnsellAnti-viralsAntibiotics and Infectious diseasesAustraliaBiotechnologyRegulationStarpharmaVivaGel

Australian Health Ministers sign on to end HIV transmissions by 2020

Australian Health Ministers sign on to end HIV transmissions by 2020

21-07-2014

All Australian Health Ministers have committed to working towards the virtual elimination of new Australian…

AIDSAnti-viralsAustraliaHealthcareHIV/AIDSPharmaceuticalPoliticsRegulation

Canada approves Pendopharm’s all-oral ribavirin treatment Ibavyr for hepatitis C

Canada approves Pendopharm’s all-oral ribavirin treatment Ibavyr for hepatitis C

16-07-2014

Quebec-based Pendopharm, a division of privately-held Canadian drugmaker Pharmascience, says the regulator…

Anti-viralsBiotechnologyCanadaIbavyrPendopharmPharmascienceRegulation

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

Bristol-Myers hepatitis C treatment Daklinza+Sunvepra OKed in Japan

Bristol-Myers hepatitis C treatment Daklinza+Sunvepra OKed in Japan

07-07-2014

The Japanese Ministry of Health, Labor and Welfare has approved Daklinza (daclatasvir), a potent, pan-genotypic…

Anti-viralsBristol-Myers SquibbDaklinzaDaklinza+SunvepraJapanPharmaceuticalRegulationSunvepra

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

Boehringer Ingelheim pulls out of hepatitis C drug development

Boehringer Ingelheim pulls out of hepatitis C drug development

23-06-2014

German family-owned pharma major Boehringer Ingelheim revealed that, following a re-evaluation of its…

Anti-viralsBoehringer IngelheimfaldaprevirPharmaceuticalRegulationResearch

EMA validates Marketing Authorization Applications for AbbVie’s hepatitis C treatment

EMA validates Marketing Authorization Applications for AbbVie’s hepatitis C treatment

17-06-2014

US drugmaker AbbVie announced today that the Marketing Authorization Applications (MAAs) for its investigational,…

AbbVieAnti-viralsPharmaceuticalRegulationRitonavir TabletsUSA

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

Achillion HCV program back on track, as FDA lifts sovaprevir study hold; initiates ACH-3422 dosing

Achillion HCV program back on track, as FDA lifts sovaprevir study hold; initiates ACH-3422 dosing

10-06-2014

US drugmaker Achillion has begun dosing ACH-3422, a uridine-analog nucleotide polymerase inhibitor, for…

ACH-3422AchillionAnti-viralsBiotechnologyRegulationResearchsovaprevir

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

IQWIG finds added benefit in adult patients for VIIV Healthcare’s Tivicay

27-05-2014

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

Anti-viralsGermanyGlaxoSmithKlinePharmaceuticalPricingRegulationTivicayViiV Healthcare

AbbVie files for Canadian approval of all-oral, interferon-free hepatitis C therapy

22-05-2014

US drugmaker AbbVie has filed a New Drug Submission to Health Canada seeking approval for its investigational,…

AbbVieAnti-viralsCanadaPharmaceuticalRegulation

Janssen’s hepatitis C drug Olysio cleared in EU

16-05-2014

Janssen-Cilag International, a subsidiary of US health care giant Johnson & Johnson, says that its next…

Anti-viralsBiotechnologyEuropeJanssen-CilagJohnson & JohnsonOlysioRegulation

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