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Gilead Sciences Inc (GILD.O)

GILD.O on Nasdaq

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20 Jul 2017
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Latest Key Developments (Source: Significant Developments)

U.S. FDA approves Gilead’s Vosevi for re-treatment of adults with chronic hepatitis C virus
Tuesday, 18 Jul 2017 01:35pm EDT 

July 18 (Reuters) - Gilead Sciences Inc :U.S. Food and Drug Administration approves Gilead’s Vosevi (sofosbuvir/velpatasvir/voxilaprevir) for re-treatment of adults with chronic hepatitis C virus.Vosevi has a boxed warning in its product label regarding risk of hepatitis B virus (HBV) reactivation in HCV/HBV coinfected patients.Vosevi's approval is based on data from phase 3 polaris-1 and polaris-4 studies.  Full Article

Spring Bank Pharmaceuticals announces clinical trial collaboration with Gilead Sciences for clinical study examining SB 9200​
Monday, 10 Jul 2017 08:30am EDT 

July 10 (Reuters) - Gilead Sciences Inc :Spring Bank Pharmaceuticals Inc - ‍announced a second clinical trial collaboration with Gilead Sciences, Inc. for a clinical study examining SB 9200​.Spring Bank Pharmaceuticals - ‍under terms of clinical trial supply, collaboration agreement, Gilead will lead Phase 2 trial with input from spring bank​.  Full Article

European CHMP adopts positive opinion for Gilead's Vosevi
Friday, 23 Jun 2017 07:35am EDT 

June 23 (Reuters) - Gilead Sciences Inc ::European CHMP adopts positive opinion for Gilead's Vosevi (sofosbuvir/velpatasvir/voxilaprevir) for the treatment of all chronic Hepatitis C genotypes.Gilead Sciences Inc says has also submitted a regulatory application for SOF/VEL/VOX in United States.Gilead Sciences Inc - Gilead has also submitted a regulatory application for SOF/VEL/VOX in United States.Gilead Sciences Inc - Food And Drug Administration (FDA) has set a target action date under prescription drug user fee act of August 8, 2017.  Full Article

Gilead receives approval in Canada for Vemlidy for treatment of chronic hepatitis b virus infection
Monday, 19 Jun 2017 05:59am EDT 

June 19 (Reuters) - Gilead Sciences Inc :Gilead receives approval in Canada for Vemlidy™ (tenofovir alafenamide) for the treatment of chronic hepatitis b virus infection.Gilead Sciences Inc - Health Canada has granted a notice of compliance for vemlidy 25mg tablets.Gilead Sciences - patients in vemlidy arm also experienced numerically higher rates of normalization of blood serum alanine aminotransferase (alt) levels.Gilead Sciences Inc - study 108, study 110 met their primary endpoint of non-inferiority to viread.  Full Article

Gilead submits NDA for fixed-dose combination for HIV treatment
Monday, 12 Jun 2017 08:15am EDT 

June 12 (Reuters) - Gilead Sciences Inc ::Gilead submits new drug application to U.S. Food and drug administration for fixed-dose combination of bictegravir, emtricitabine and tenofovir alafenamide for HIV treatment.Investigational single tablet regimen may have potential to advance triple-therapy hiv treatment for a broad range of patients.Plans to submit a marketing authorization application for bic/ftc/taf in european union in Q3 of 2017.NDA for bic/ftc/taf is supported by data from four phase 3 studies in which regimen met its primary objective of non-inferiority.  Full Article

Gilead Sciences says Genvoya tablets, for HIV-1 treatment, is now listed in multiple provinces in Canada
Thursday, 4 May 2017 09:44am EDT 

May 4 (Reuters) - Gilead Sciences Inc : :Genvoya tablets, for treatment of HIV-1 infection is now listed in multiple provinces in Canada as well as in NIHB drug plan for First Nations, Inuit.  Full Article

Gilead Sciences says Nova Scotia lists Epclusa on public drug plan to treat all six genotypes of Chronic Hepatitis C infection
Monday, 1 May 2017 07:00am EDT 

May 1 (Reuters) - Gilead Sciences Inc :Gilead sciences inc - nova scotia lists epclusa on public drug plan to treat all six genotypes of chronic hepatitis c infection.Effective immediately, nova scotia will provide public access to epclusa (sofosbuvir/velpatasvir) tablets.  Full Article

Gilead announces results from 2 Phase 2 studies evaluating Harvoni tablets in chronic hepatitis C infected patient populations
Friday, 21 Apr 2017 12:00pm EDT 

April 21 (Reuters) - Gilead Sciences Inc ::Results from 2 Phase 2 studies evaluating Harvoni tablets in chronic hepatitis C infected patient populations.Studies demonstrated HCV cure rates of 99 percent in children aged 6 to 11 years, and 100 percent in adult patients co-infected with HCV and HBV.In Karen Murray led study, 1 treatment-naïve genotype 1 patient relapsed; other patients achieved SVR12, primary efficacy endpoint .In Chun-Jen Liu led study, 3 patients had serious adverse events that were not considered to be drug-related .Most common adverse events reported from Chun-Jen Liu led study were headache, upper respiratory infection, fatigue .  Full Article

FDA approves two of Gilead's hepatitis C drugs for pediatric patients
Friday, 7 Apr 2017 10:11am EDT 

Gilead Sciences Inc : U.S. FDA approves new indications for Harvoni and Sovaldi in pediatric patients 12 years and older with chronic hepatitis C infection . Harvoni, Sovaldi each have boxed warning in their respective product labels .Boxed warning for the two drugs relate to risk of hepatitis B virus reactivation in HCV/HBV co-infected patients.  Full Article

Gilead Sciences CEO John Milligan's 2016 total compensation was $13.9 mln- SEC Filing
Monday, 27 Mar 2017 05:36pm EDT 

Gilead Sciences Inc : Gilead Sciences Inc- CEO John F. Milligan's 2016 total compensation was $13.9 million- SEC Filing . Executive chairman John Martin's FY 2016 total compensation was $10.4 million . CFO Robin Washington's FY 2016 total compensation was $5.1 million versus $5.6 million in FY 2015 .Chief Scientific Officer Norbert Bischofberger's FY 2016 total compensation was $6.2 million versus $6.95 million in FY 2015.  Full Article

FDA approves Gilead's drug for chronic hep C patients

Gilead Sciences Inc said on Tuesday that the U.S. Food and Drug Administration approved its hepatitis C drug for patients who had failed to respond to prior treatments.