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Gilead Sciences Inc (GILD.OQ)

GILD.OQ on NASDAQ Stock Exchange Global Select Market

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18 Jun 2018
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Latest Key Developments (Source: Significant Developments)

Gilead Sciences Says China Drug Administration Approves Epclusa
Wednesday, 30 May 2018 01:00am EDT 

May 30 (Reuters) - Gilead Sciences Inc ::GILEAD SCIENCES INC - CHINA DRUG ADMINISTRATION APPROVES EPCLUSA(SOFOSBUVIR/VELPATASVIR), GILEAD'S PAN-GENOTYPIC TREATMENT FOR CHRONIC HEPATITIS C VIRUS INFECTION.GILEAD SCIENCES INC - EPCLUSA IS FIRST PAN-GENOTYPIC HCV SINGLE TABLET REGIMEN (STR) APPROVED IN CHINA..  Full Article

Gilead: Natco And Teva Requested FDA Permission To Make Generic Version Of Sovaldi - SEC Filing
Tuesday, 27 Feb 2018 06:41am EST 

Feb 27 (Reuters) - Gilead Sciences Inc ::GILEAD SCIENCES INC SAYS IN FEBRUARY 2018, CO RECEIVED NOTICES FROM NATCO PHARMA LIMITED AND TEVA PHARMA - SEC FILING.GILEAD SCIENCES INC - NATCO PHARMA LIMITED,TEVA EACH SUBMITTED ANDA TO FDA REQUESTING PERMISSION TO MANUFACTURE AND MARKET GENERIC VERSION OF SOVALDI.GILEAD SCIENCES - TEVA ALLEGES THAT NINE PATENTS ASSOCIATED WITH SOFOSBUVIR INVALID, UNENFORCEABLE AND/OR WILL NOT BE INFRINGED BY TEVA’S MANUFACTURE.GILEAD SCIENCES-NATCO PHARMA ALLEGES THAT TWO PATENTS ASSOCIATED WITH SOFOSBUVIR INVALID,UNENFORCEABLE AND/OR WILL NOT BE INFRINGED BY NATCO’S MANUFACTURE.  Full Article

EMA Says Gilead Pulls Application To Extend Use Of Zydelig Drug ‍​
Friday, 23 Feb 2018 07:25am EST 

Feb 23 (Reuters) - EU MEDICINES AGENCY :APPLICATION TO EXTEND USE OF GILEAD SCIENCES ZYDELIG DRUG FOR TREATMENT OF CHRONIC LYMPHOCYTIC LEUKAEMIA WITHDRAWN ‍​‍​.  Full Article

Kite, Sangamo Therapeutics Announce Collaboration To Develop Next-Generation Engineered Cell Therapies For Treatment Of Cancer
Thursday, 22 Feb 2018 07:00am EST 

Feb 22 (Reuters) - Sangamo Therapeutics Inc ::KITE, A GILEAD COMPANY, AND SANGAMO THERAPEUTICS ANNOUNCE COLLABORATION TO DEVELOP NEXT-GENERATION ENGINEERED CELL THERAPIES FOR THE TREATMENT OF CANCER.SANGAMO THERAPEUTICS - KITE TO RECEIVE EXCLUSIVE LICENSE TO LEVERAGE SANGAMO'S GENE EDITING TECHNOLOGY IN ALLOGENEIC AND AUTOLOGOUS CELL THERAPY PROGRAMS IN ONCOLOGY.SANGAMO THERAPEUTICS INC - UNDER TERMS OF AGREEMENT, SANGAMO WILL RECEIVE AN UPFRONT PAYMENT OF $150 MILLION.SANGAMO THERAPEUTICS INC - UNDER TERMS, SANGAMO IS ELIGIBLE TO RECEIVE UP TO $3.01 BILLION IN POTENTIAL PAYMENTS.SANGAMO THERAPEUTICS INC - KITE WILL BE RESPONSIBLE FOR AGREED UPON EXPENSES INCURRED BY SANGAMO.SANGAMO THERAPEUTICS INC - CO WOULD ALSO RECEIVE TIERED ROYALTIES ON SALES OF POTENTIAL FUTURE PRODUCTS RESULTING FROM COLLABORATION.  Full Article

Kite And Sangamo Therapeutics Announce Collaboration To Develop Cell Therapies For Treatment Of Cancer
Thursday, 22 Feb 2018 07:00am EST 

Feb 22 (Reuters) - Sangamo Therapeutics Inc ::KITE, A GILEAD COMPANY, AND SANGAMO THERAPEUTICS ANNOUNCE COLLABORATION TO DEVELOP NEXT-GENERATION ENGINEERED CELL THERAPIES FOR THE TREATMENT OF CANCER.SANGAMO THERAPEUTICS INC - SANGAMO WILL RECEIVE AN UPFRONT PAYMENT OF $150 MILLION AND IS ELIGIBLE TO RECEIVE UP TO $3.01 BILLION IN POTENTIAL PAYMENTS.SANGAMO THERAPEUTICS INC - KITE WILL BE RESPONSIBLE FOR ALL DEVELOPMENT, MANUFACTURING AND COMMERCIALIZATION OF PRODUCTS UNDER COLLABORATION.  Full Article

Shionogi says ViiV Healthcare files patent infringement litigation against Gilead Sciences over bictegravir
Thursday, 8 Feb 2018 02:06am EST 

Feb 8 (Reuters) - Shionogi & Co Ltd <4507.T>:Says it announced that ViiV Healthcare, the global specialist HIV company majority-owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, has filed patent infringement litigation against Gilead Sciences Inc. over bictegravir in the United States and Canada.The United States case is filed in the U.S. District Court for the District of Delaware and the patent is U.S patent No. 8,129,385.The Canadian case is filed in the Canadian Federal Court in Toronto and the patent is Canadian Patent No. 2,606,282..  Full Article

Gilead Sciences Says FDA Approves Biktarvy For Treatment Of HIV-1 Infection
Wednesday, 7 Feb 2018 02:22pm EST 

Feb 7 (Reuters) - Gilead Sciences Inc ::U.S. FOOD AND DRUG ADMINISTRATION APPROVES GILEAD’S BIKTARVY® (BICTEGRAVIR, EMTRICITABINE, TENOFOVIR ALAFENAMIDE) FOR TREATMENT OF HIV-1 INFECTION.GILEAD SCIENCES INC - BIKTARVY HAS A BOXED WARNING IN ITS PRODUCT LABEL REGARDING RISK OF POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B.GILEAD SCIENCES - ‍ADDITIONAL CLINICAL TRIALS OF BIKTARVY ONGOING, INCLUDING A DEDICATED STUDY IN WOMEN; PLANS TO PRESENT DATA FROM STUDIES IN 2018​.GILEAD SCIENCES - APPROVAL OF BIKTARVY SUPPORTED BY DATA FROM 4 ONGOING PHASE 3 STUDIES INCLUDING STUDIES 1489 & 1490 IN TREATMENT-NAÏVE HIV-1 INFECTED ADULTS.GILEAD SCIENCES - APPROVAL OF BIKTARVY SUPPORTED BY DATA FROM 4 ONGOING PHASE 3 STUDIES INCLUDING STUDIES 1844 & 1878 IN VIROLOGICALLY SUPPRESSED ADULTS.  Full Article

Gilead Sciences Announces Qtrly Loss Per Share $2.96
Tuesday, 6 Feb 2018 04:01pm EST 

Feb 6 (Reuters) - Gilead Sciences Inc ::GILEAD SCIENCES ANNOUNCES FOURTH QUARTER AND FULL YEAR 2017 FINANCIAL RESULTS.QTRLY TOTAL REVENUES $5,949 MILLION VERSUS $7,320 MILLION.QTRLY LOSS PER SHARE $2.96.QTRLY NON-GAAP DILUTED EARNINGS PER SHARE $ 1.78 ‍​.NET LOSS FOR FOURTH QUARTER INCLUDES ESTIMATED $5.5 BILLION CHARGE RELATED TO ENACTMENT OF THE TAX CUTS AND JOBS ACT‍​.QTRLY HARVONI SALES $644 MILLION VERSUS $1,640 MILLION.SEES FY 2018 DILUTED EPS IMPACT OF ACQUISITION-RELATED, UP-FRONT COLLABORATION, STOCK-BASED COMPENSATION AND OTHER EXPENSES OF $1.41 - $1.51.QTRLY SOVALDI SALES $117 MILLION VERSUS $541 MILLION.Q4 EARNINGS PER SHARE VIEW $1.67, REVENUE VIEW $5.74 BILLION -- THOMSON REUTERS I/B/E/S.SEES FULL YEAR 2018 NET PRODUCT SALES $20,000 MILLION - $21,000 MILLION.FY2018 REVENUE VIEW $21.97 BILLION -- THOMSON REUTERS I/B/E/S.  Full Article

Teva Announces Exclusive Launch Of Generic Viread® In The United States
Friday, 15 Dec 2017 09:00am EST 

Dec 15 (Reuters) - Teva Pharmaceutical Industries Ltd ::TEVA ANNOUNCES EXCLUSIVE LAUNCH OF GENERIC VIREAD® IN THE UNITED STATES.TEVA ANNOUNCES EXCLUSIVE LAUNCH OF GENERIC VIREAD® IN THE UNITED STATES.TEVA PHARMACEUTICAL INDUSTRIES LTD - ANNOUNCED EXCLUSIVE LAUNCH OF GENERIC VIREAD TABLETS 300 MG IN U.S..  Full Article

Gilead Sciences and Kite To Acquire Cell Design Labs
Thursday, 7 Dec 2017 05:00pm EST 

Dec 7 (Reuters) - Gilead Sciences Inc ::GILEAD SCIENCES AND KITE TO ACQUIRE CELL DESIGN LABS.GILEAD SCIENCES INC - DEAL FOR UP TO APPROXIMATELY $567 MILLION.GILEAD SCIENCES INC - AGREEMENT INCLUDES AN INITIAL UPFRONT PAYMENT OF APPROXIMATELY $175 MILLION.GILEAD SCIENCES - DEAL INCLUDES ADDITIONAL PAYMENTS OF UP TO $322 MILLION PAID TO SHAREHOLDERS OF CELL DESIGN LABS OTHER THAN KITE UPON OCCURRENCE OF CERTAIN EVENTS.GILEAD SCIENCES - CO, CELL THERAPY UNIT KITE ANNOUNCED THEY ENTERED INTO A DEFINITIVE AGREEMENT UNDER WHICH THEY AGREED TO ACQUIRE CELL DESIGN LABS.GILEAD SCIENCES - WILL BUY ALL OF CELL DESIGN LABS' SHARES, WHICH INCLUDES ABOUT 12.2 PERCENT OF SHARES OF CELL DESIGN LABS CURRENTLY HELD BY KITE.  Full Article

UPDATE 2-GSK's two-drug HIV treatment meets main goal in late stage studies

June 14 GlaxoSmithKline's two-drug treatment for HIV, the virus that causes AIDS, met its main goal in late stage studies, scoring key points in its rivalry with Gilead in the medical field.