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Gilead Sciences Inc (GILD.O)

GILD.O on Nasdaq

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19 Oct 2017
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Latest Key Developments (Source: Significant Developments)

FDA approves Gilead's CAR-T cell therapy
Wednesday, 18 Oct 2017 06:23pm EDT 

Oct 18 (Reuters) - U.S. Food and Drug Administration -:FDA approves CAR-T cell therapy to treat adults with certain types of large B-cell lymphoma.FDA says granted approval of Yescarta to Kite Pharma Inc.FDA says Yescarta carries a boxed warning for Cytokine release syndrome‍​.FDA says due to risk of CRS and neurologic toxicities, Yescarta is being approved with risk evaluation and mitigation strategy.FDA says it is requiring that hospitals and their associated clinics that dispense Yescarta be specially certified.  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

Gilead sciences, WHO announce 5-year visceral leishmaniasis collaboration
Tuesday, 27 Sep 2016 04:05pm EDT 

Gilead Sciences : Gilead Sciences and the World Health Organization announce five-year visceral leishmaniasis collaboration . Partnership with World Health Organization to expand access to diagnostic services and treatment for visceral leishmaniasis .Gilead donates $20 million to enhance access to treatment for often fatal neglected tropical disease.  Full Article

Genmab enters commercial license agreement with Gilead for DuoBody(R)Technology
Wednesday, 10 Aug 2016 01:07pm EDT 

Genmab A/S : Genmab enters commercial license agreement with Gilead for DuoBody(R) Technology . Genmab is entitled to potential development, regulatory and sales milestones of up to USD 277 million . Agreement is not expected to have a material impact on Genmab's 2016 financial guidance . Genmab will receive an upfront payment of USD 5 million from Gilead Sciences . Genmab will be entitled to single-digit royalties on Gilead's sales of any commercialized products . Deal also includes further milestones for subsequent products .Commercial license agreement follows a research collaboration between Genmab and Gilead Sciences for DuoBody Technology signed in 2014.  Full Article

BRIEF-Massachusetts attorney general's office notifies Gilead of decision to suspend co's obligations under CID until further notice
Friday, 5 Aug 2016 05:05pm EDT 

Gilead Sciences : In July 2016, Massachusetts attorney general's office notified co of their decision to suspend co's obligations under CID until further notice .Civil investigative demand related to attorney general's office requesting that co produce documents related to its HCV products.  Full Article

Gilead Sciences sets qtrly dividend of $0.47 per share
Monday, 25 Jul 2016 04:10pm EDT 

Gilead Sciences Inc : Sets quarterly cash dividend of $0.47per share .Sets quarterly cash dividend of $0.47per share.  Full Article

Gilead Sciences Q2 non-GAAP earnings per share $3.08
Monday, 25 Jul 2016 04:08pm EDT 

Gilead Sciences Inc : Q2 Harvoni sales $ 2.56 billion versus $3.61 billion last year . Revised full year 2016 guidance . Q2 Sovaldi sales $ 1.36 billion versus $1.29 billion last year . Sees Fy Diluted EPS Impact Of Acquisition-Related, restructuring, stock-based compensation expenses and other $1.47 - $1.53 . Fy2016 revenue view $31.02 billion -- Thomson Reuters I/B/E/S . Gilead Sciences announces second quarter 2016 financial results . Q2 non-GAAP earnings per share $3.08 . Q2 earnings per share $2.58 . Q2 earnings per share view $3.02 -- Thomson Reuters I/B/E/S . Q2 total revenue $7.78 billion versus $8.24 billion last year . Q2 revenue view $7.77 billion -- Thomson Reuters I/B/E/S . Revised full year 2016 guidance .Sees NON-GAAP FY net product sales $29.5 - $30.5 billion.  Full Article

EMA adopts positive opinion on expanded approval of Gilead's HIV drug, Truvada
Friday, 22 Jul 2016 07:17am EDT 

Gilead Sciences Inc : European CHMP adopts positive opinion on Gilead's type II variation application for Truvada® for reducing the risk of sexually acquired HIV. . CHMP's recommendation to be reviewed by european commission . Within EU, Truvada is currently available for prep in france under a temporary recommendation for use by French regulatory agency. .Gilead Sciences Inc says use of Truvada for prep is investigational in EU and its safety and efficacy have not been established..  Full Article

Gilead's Odefsey meets primary objective in phase 3B studies
Thursday, 21 Jul 2016 04:30pm EDT 

Gilead Sciences Inc : Odefsey® (Emtricitabine, Rilpivirine, Tenofovir Alafenamide) Meets Primary 48-Week objective in two phase 3B studies .Plans to submit data for presentation at scientific conferences in 2016..  Full Article

Ligand enters into Omniab platform license agreement with Gilead Sciences
Friday, 8 Jul 2016 09:00am EDT 

Ligand Pharmaceuticals Inc : Ligand enters into Omniab® platform license agreement with Gilead Sciences . Gilead will be responsible for all costs related to programs .Ligand is eligible to receive annual platform access payments, milestone payments and royalties.  Full Article

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FDA approves Gilead cancer gene therapy; price set at $373,000

U.S. regulators approved on Wednesday a new therapy for a type of lymphoma, which was developed by Gilead Science Inc's Kite Pharma, marking the second approval for this potentially revolutionary approach to fighting cancer.