Key Developments: Gilead Sciences Inc (GILD.OQ)

GILD.OQ on NASDAQ Stock Exchange Global Select Market

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Latest Key Developments (Source: Significant Developments)

European CHMP Adopts positive opinion for Gilead Sciences Inc's Zydelig
Friday, 25 Jul 2014 07:24am EDT 

Gilead Sciences Inc:Announced Committee for Medicinal Products for Human Use (CHMP), scientific committee of European Medicines Agency (EMA), has adopted positive opinion on company's Marketing Authorization Application (MAA) for Zydelig(idelalisib 150 mg film-coated tablets).Zydelig, first-in-class treatment for patients with chronic lymphocytic leukemia (CLL) and follicular lymphoma (FL), most common subtype of indolent non-Hodgkin lymphoma (iNHL).CHMP opinion supports use of Zydelig in combination with rituximab for treatment of adult patients with CLL.CHMP's recommendation will be reviewed by European Commission, which has authority to approve medicines for use in 28 countries of European Union (EU).CHMP positive opinion for Zydelig is based on data from two clinical trials - Study 116 and Study 101-09. Study 116, a pivotal Phase 3 trial, investigated the efficacy and safety of Zydelig in combination with rituximab in patients with previously treated CLL.Phase 2 101-09 study assessed efficacy and safety of Zydelig in patients with iNHL who are refractory to rituximab and alkylating agents.  Full Article

Gilead Sciences Inc announces new agreement with medicines patent pool for access to medicines in developing world countries
Thursday, 24 Jul 2014 12:01am EDT 

Gilead Sciences Inc:Says new agreement with the Medicines Patent Pool (MPP) to expand access to Gilead's investigational drug tenofovir alafenamide for HIV and hepatitis B, contingent on the medicine's U.S. regulatory approval.Under the agreement, the MPP can sub-license TAF to generic drug companies in India and China, who may manufacture and distribute it in 112 developing countries.  Full Article

Gilead Sciences Inc raises FY 2014 net product sales guidance
Wednesday, 23 Jul 2014 04:05pm EDT 

Gilead Sciences Inc:Updates FY 2014 guidance, which it initially provided on Feb. 4, and reiterated on April 22.Raises FY 2014 net product sales in the range of $21.00 - $23.00 bln (previous range $11.30 - $11.50 bln).  Full Article

U.S. Food and Drug Administration approves Gilead Sciences Inc' s Zydelig for relapsed chronic lymphocytic leukemia, follicular lymphoma and small lymphocytic lymphoma
Wednesday, 23 Jul 2014 11:49am EDT 

Gilead Sciences Inc:Announces that the U.S. Food and Drug Administration (FDA) has approved Zydelig 150 mg tablets for the treatment of three B-cell blood cancers.Zydelig is indicated in combination with rituximab for patients with relapsed chronic lymphocytic leukemia (CLL) for whom rituximab alone would be considered appropriate therapy and as monotherapy for patients.Accelerated approval was granted for FL and SLL based on overall response rate.Zydelig is a first-in-class inhibitor of PI3K delta, a protein that is over-expressed in many B-cell malignancies and plays a role in the viability, proliferation and migration of these cancer cells.  Full Article

Gilead Sciences Inc submits New Drug Application to Japan's Pharmaceutical and Medical Devices Agency for Sofosbuvir for Chronic Hepatitis C
Friday, 27 Jun 2014 03:01am EDT 

Gilead Sciences Inc:Says it has submitted New Drug Application (NDA) to Japan's Pharmaceutical and Medical Devices Agency (PMDA) for approval of sofosbuvir, once-daily nucleotide analog polymerase inhibitor for treatment of chronic hepatitis C virus (HCV) infection.Data in NDA support use of sofosbuvir with ribavirin (RBV) for 12 weeks in patients with genotype 2 HCV infection.If approved, sofosbuvir would form basis of first all-oral, interferon-free treatment regimen for genotype 2 patients in Japan.Primarily due to HCV, Japan has one of the highest rates of liver cancer of any industrialized country.Of more than one mln people chronically infected with HCV, 20-30 percent have the genotype 2 strain of the virus.Currently approved therapies in Japan for genotype 2 HCV infection involve 24-48 weeks of injections with pegylated interferon, which may not be suitable for certain patients.  Full Article

Gilead Sciences Inc announces phase 3 data showing that fixed-dose combination of Ledipasvir/Sofosbuvir achieved 100 pct. sustained virologic response among patients with chronic hepatitis C in Japan
Sunday, 15 Jun 2014 08:00pm EDT 

Gilead Sciences Inc:Announces topline results from a Phase 3 clinical trial (GS-US-337-0113) in Japan evaluating investigational once-daily fixed-dose combination of NS5A inhibitor ledipasvir (LDV) 90 mg.And nucleotide analog polymerase inhibitor sofosbuvir (SOF) 400 mg, with and without ribavirin (RBV), for treatment of genotype 1 chronic hepatitis C virus (HCV) infection.Among patients receiving 12 weeks of LDV/SOF without RBV, 100 pct. (n=83/83) of treatment-naïve and 100 pct. (n=88/88) of treatment-experienced patients achieved a sustained virologic response 12 weeks after completing therapy (SVR12).Among patients receiving LDV/SOF plus RBV, 96 percent (n=80/83) of treatment-naïve and 100 pct. of treatment-experienced patients (n=87/87) achieved SVR12.Across all arms of study, patients with cirrhosis achieved 99 pct. (n=75/76) SVR12.Study met its primary endpoint of superiority compared to a predefined historical SVR12 rate.Patients who achieve SVR12 are considered cured of HCV infection.  Full Article

Gilead Sciences Inc's investigational GS-5806 reduces viral load and clinical symptoms in phase 2 respiratory syncytial virus challenge study in adults
Tuesday, 20 May 2014 05:00pm EDT 

Gilead Sciences Inc:Announced results from a placebo-controlled, Phase 2a challenge study in healthy adult patients intranasally infected with respiratory syncytial virus.Study of GS-5806, an investigational oral RSV fusion inhibitor, achieved its primary and secondary endpoints of lower viral load, improvements in total mucus weight and also symptom diary score compared to placebo.  Full Article

Gilead Sciences Inc announces phase 1 data for investigational therapy, GS-6615, in patients with long qt-3 syndrome
Friday, 9 May 2014 04:30pm EDT 

Gilead Sciences Inc:Announced results from a Phase 1 clinical trial of GS-6615, an investigational, selective late sodium current inhibitor, showing a shortening of the QTc interval in patients with long QT-3 (LQT3) syndrome.LQT3 is a genetic disorder that prolongs the heart's QTc interval and can cause life-threatening cardiac arrhythmias.In this study, ten LQT3 patients were evaluated at the Clinical Research Center at the University of Rochester, where they received single oral doses of GS-6615 ranging from 10 mg to 60 mg.  Full Article

Gilead Sciences Inc announces $5 bln share repurchase program
Wednesday, 7 May 2014 05:17pm EDT 

Gilead Sciences Inc:Authorizes a repurchase of up to $5 billion of the company's common stock.New program expires three years after the completion of the current repurchase program.  Full Article

Gilead Sciences reiterates FY 2014 net product sales guidance
Tuesday, 22 Apr 2014 04:02pm EDT 

Gilead Sciences Inc:Reiterates FY 2014 guidance initially provided on Feb. 4.Sees FY 2014 net product sales in the range of $11.300 - $11.500 billion.  Full Article

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