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Gilead

European Commission Grants Marketing Authorization for Gilead’s Harvoni®▼ (Ledipasvir/Sofosbuvir), the First Single Tablet Regimen to Treat the Majority of Chronic Hepatitis C Patients With Genotype 1 and 4

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Once-Daily Single Tablet Regimen Eliminates the Need for Interferon and Ribavirin for Patients with Genotype 1 and 4 Hepatitis C without Cirrhosis or with Compensated Cirrhosis FOSTER CITY, Calif.–(BUSINESS WIRE)–Nov. 18, 2014– Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the European Commission has granted marketing authorization for Harvoni® (ledipasvir 90 mg/sofosbuvir 400 mg), the first […]

Gilead Announces Harvoni Study Results in Chronic Hepatitis C Patients with Advanced Liver Disease and Those Who Failed Prior Treatment

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High Cure Rates in Nearly 800 HCV Patients with Advanced Liver Disease BOSTON–(BUSINESS WIRE)–Nov. 11, 2014– Gilead Sciences, Inc. (Nasdaq: GILD) today announced results from several Phase 2 and Phase 3 studies evaluating investigational uses of Harvoni® (ledipasvir 90 mg/sofosbuvir 400 mg) for the treatment of chronic hepatitis C virus (HCV) infection in patients with […]

Gilead Submits New Drug Application to U.S. Food and Drug Administration for Tenofovir Alafenamide (TAF)-Based Single Tablet Regimen for HIV

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High Rates of Viral Suppression and Improved Renal and Bone Safety Demonstrated in Phase 3 Studies First of Several TAF-Based Single Tablet Regimens Being Evaluated by Gilead FOSTER CITY, Calif.–(BUSINESS WIRE)–Nov. 6, 2014– Gilead Sciences, Inc. (NASDAQ: GILD) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug […]

U.S. Food and Drug Administration Approves Gilead’s Harvoni® (Ledipasvir/Sofosbuvir), the First Once-Daily Single Tablet Regimen for the Treatment of Genotype 1 Chronic Hepatitis C

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Harvoni Achieved Cure Rates (SVR12) of 94-99 Percent in Three Phase 3 Studies Shortens Treatment Duration to Just Eight Weeks for Certain Treatment-Naïve Patients Eliminates Need for Interferon and Ribavirin for Patients with Genotype 1 Hepatitis C FOSTER CITY, Calif.–(BUSINESS WIRE)–Oct. 10, 2014– Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and […]

Gilead’s Investigational Tenofovir Alafenamide (TAF)-Based Single Tablet HIV Regimen Meets 48-Week Primary Objective in Two Phase 3 Studies

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U.S. and EU Filings Planned for Q4 2014 FOSTER CITY, Calif.–(BUSINESS WIRE)–Sep. 24, 2014– Gilead Sciences, Inc. (Nasdaq:GILD) today announced that two Phase 3 clinical trials (Studies 104 and 111) evaluating an investigational once-daily single tablet regimen containing tenofovir alafenamide (TAF) for the treatment of HIV-1 infection in treatment-naïve adults met their primary objectives. The […]

Gilead Submits New Drug Application to Japan’s Pharmaceutical and Medical Devices Agency for Fixed-Dose Combination of Ledipasvir/Sofosbuvir for Chronic Hepatitis C Genotype 1 Infection

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12-Week Course of Ledipasvir/Sofosbuvir Achieved 100 Percent Sustained Virologic Response (SVR12) in Japanese Phase 3 Study Ledipasvir/Sofosbuvir Simplifies Hepatitis C Treatment to a Single, Once-Daily Tablet FOSTER CITY, Calif.–(BUSINESS WIRE)–Sep. 24, 2014– Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the company has submitted a New Drug Application (NDA) to Japan’s Pharmaceutical and Medical Devices Agency […]

Gilead Announces Data From Phase 2 Study of Simtuzumab for Previously Untreated Pancreatic Cancer

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Data to be Presented at European Society for Medical Oncology Congress in Madrid FOSTER CITY, Calif.–(BUSINESS WIRE)–Sep. 17, 2014– Gilead Sciences, Inc. (Nasdaq:GILD) today announced results from a Phase 2 study evaluating simtuzumab, an investigational inhibitor of lysyl oxidase-like-2 (LOXL2), in combination with gemcitabine for patients with previously untreated advanced pancreatic cancer. In the study, […]

First-Line Combination of Ambrisentan and Tadalafil Reduces Risk of Clinical Failure Compared to Monotherapy in Pulmonary Arterial Hypertension Outcomes Study

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AMBITION Study of Ambrisentan/Tadalafil Combination Therapy Versus Monotherapy Achieves Primary Endpoint of Time to First Clinical Failure Event Data Presented at the ERS International Congress 2014 MUNICH–(BUSINESS WIRE)–Sep. 8, 2014– Gilead Sciences, Inc. (Nasdaq:GILD) today announced results from the AMBITION study (a randomized, double-blind, multicenter study of first-line combination therapy with AMBrIsentan and Tadalafil in […]

European CHMP Adopts Positive Opinion for Gilead’s Zydelig® (idelalisib) for the Treatment of Chronic Lymphocytic Leukemia and Follicular Lymphoma

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FOSTER CITY, Calif.–(BUSINESS WIRE)–Jul. 25, 2014– Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion on the company’s Marketing Authorization Application (MAA) for Zydelig® (idelalisib 150 mg film-coated tablets), a first-in-class treatment for patients […]

Gilead Announces New Agreement with Medicines Patent Pool for Access to Medicines in Developing World Countries

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Agreement provides license for generic production of tenofovir alafenamide, an investigational agent for the treatment of HIV and chronic hepatitis B MELBOURNE, Australia–(BUSINESS WIRE)–Jul. 24, 2014– Gilead Sciences, Inc. (NASDAQ:GILD) announced today at the 20th International AIDS Conference in Melbourne, Australia, a new agreement with the Medicines Patent Pool (MPP) to expand access to Gilead’s […]

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