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UK NICE consults on draft guidance for Gilead’s hepatitis C drug Sovaldi

UK NICE consults on draft guidance for Gilead’s hepatitis C drug Sovaldi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

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

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

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

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

“Overwhelming approval” in store for Heplisav if Dynavax delivers sufficient safety data, says analyst

“Overwhelming approval” in store for Heplisav if Dynavax delivers sufficient safety data, says analyst

27-02-2014

Despite citing the need for further safety studies, both US and EU regulators have lauded the immunogenicity…

Anti-viralsBiotechnologyDynavax TechnologiesHeplisavRegulationResearchVaccines

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

Dynavax withdraws European MAA for Heplisav

18-02-2014

US biotech firm Dynavax Technologies says it has withdrawn the European Marketing Authorization Application…

Anti-viralsBiotechnologyDynavax TechnologiesEuropeHeplisavRegulationVaccines

Gilead’s Sovaldi gains EC approval for chronic hepatitis C

Gilead’s Sovaldi gains EC approval for chronic hepatitis C

20-01-2014

US antivirals specialist Gilead Sciences has received marketing authorization from the European Commission…

Anti-viralsBiotechnologyEuropeGilead SciencesPricingRegulationSovaldi

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

Gilead's Vitekta gains European Commission approval

Gilead's Vitekta gains European Commission approval

18-11-2013

The European Commission has granted marketing authorization for US biotech firm Gilead Sciences’ Vitekta…

Anti-viralsBiotechnologyelvitegravirEuropeGilead SciencesRegulationVitekta

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

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

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

Stribild in HIV shows lesser benefit for treatment-naive patients, says IQWiG

Stribild in HIV shows lesser benefit for treatment-naive patients, says IQWiG

20-09-2013

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

Anti-viralsBiotechnologyEuropeGilead SciencesPricingRegulationStribild

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

Vertex slumps as FDA delays hepatitis C trial

26-07-2013

US drug maker Vertex Pharmaceuticals (Nasdaq: VRTX) saw its shares drop 11% to $78 a share, in after-hours…

Anti-viralsBiotechnologyNorth AmericaPharmaceuticalRegulationResearchVertexVX-135

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