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Gilead Sciences Inc (GILD.OQ)

GILD.OQ on NASDAQ Stock Exchange Global Select Market

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Latest Key Developments (Source: Significant Developments)

Temasek Holdings cuts share stake in Gilead Sciences
Monday, 14 Aug 2017 09:06am EDT 

Aug 14 (Reuters) - Temasek Holdings (Private) Ltd :Temasek Holdings (Private) Ltd cuts share stake in Gilead Sciences ‍​by 23 percent to 11.1 million shares - SEC filing.Temasek Holdings (Private) Ltd - Change in holdings are as of June 30, 2017 and compared with the previous quarter ended as of March 31, 2017.  Full Article

FDA grants priority status to Gilead's HIV treatments
Thursday, 10 Aug 2017 04:01pm EDT 

Aug 10 (Reuters) - Gilead Sciences Inc -:Gilead announces U.S. fda priority review designation for fixed-dose combination of bictegravir, emtricitabine and tenofovir alafenamide for treatment of HIV.Gilead Sciences Inc - ‍FDA has set a target action date under prescription drug user fee act (pdufa) of February 12, 2018​.  Full Article

Gilead Sciences says European Commission grants marketing authorization for Vosevi
Friday, 28 Jul 2017 05:46am EDT 

July 28 (Reuters) - Gilead Sciences Inc ::European Commission grants marketing authorization for Gilead’s Vosevi® (sofosbuvir/velpatasvir/voxilaprevir) for the treatment of all genotypes of chronic hepatitis C.Vosevi was authorized as a 12-week treatment regimen for patients with any genotype of chronic hepatitis C virus infection.Also announced an extension of marketing authorization for Harvoni (ledipasvir 90mg/sofosbuvir 400mg).Indication for Harvoni extended to include treatment of chronic HCV genotype 1, 3, 4, 5, 6 infection in adolescents aged 12 to < 18 yrs.  Full Article

Gilead Sciences qtrly ‍diluted earnings per share $2.33​
Wednesday, 26 Jul 2017 04:01pm EDT 

July 26 (Reuters) - Gilead Sciences Inc ::Revised full year 2017 guidance.Qtrly ‍total revenues were $7.1 billion in 2017 compared to $7.8 billion in 2016​.Gilead Sciences Inc - qtrly ‍diluted earnings per share $2.33​.Gilead Sciences Inc - qtrly ‍non-gaap diluted earnings per share $2.56​.Gilead Sciences Inc - sees FY diluted EPS impact of acquisition-related, up-front collaboration, stock-based compensation and other expenses ‍$0.86 - $0.93​.Q2 Harvoni sales $1,382 million versus $2,564 million last year.Gilead Sciences Inc - sees ‍FY net product sales $24,000 million - $25,500 million ​.Q2 Sovaldi sales $315 million versus $1,358 million last year.Q2 earnings per share view $2.15, revenue view $6.35 billion -- Thomson Reuters I/B/E/S.Fy2017 revenue view $24.77 billion -- Thomson Reuters I/B/E/S.  Full Article

Mylan receives who prequalification for Generic Sovaldi
Wednesday, 26 Jul 2017 09:45am EDT 

July 26 (Reuters) - Mylan Nv :Mylan receives who prequalification for generic sovaldi®.Approval from World Health Organization prequalification of medicines program of its application for Sofosbuvir tablets, 400 mg.Sofosbuvir, a directly acting antiretroviral, will be available in developing countries to treat hepatitis C.  Full Article

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

BRIEF-Gilead receives approval in Canada for Vosevi for re-treatment of certain patients with chronic hep c virus infection

* Gilead receives approval in Canada for Vosevi™ (sofosbuvir/velpatasvir/voxilaprevir) for re-treatment of certain patients with chronic hepatitis c virus (HCV) infection Source text for Eikon: Further company coverage: