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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 […]

Roche’s investigational combination of cobimetinib plus Zelboraf® (vemurafenib) provided significant benefit to people with advanced melanoma over Zelboraf alone

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Cobimetinib plus Zelboraf reduced the risk of disease worsening by half compared to Zelboraf alone Phase III coBRIM study results will be presented today during the Presidential Symposium at the European Society of Medical Oncology (ESMO) 2014 Congress and published in the New England Journal of Medicine Roche has submitted an EU marketing authorisation application […]

Roche’s Perjeta regimen extended the lives of people with an aggressive type of metastatic breast cancer by 15.7 months compared to Herceptin and chemotherapy

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Final data from Phase III CLEOPATRA study showed people with previously untreated HER2-positive metastatic breast cancer who received Perjeta, Herceptin and docetaxel chemotherapy lived a median of 56.5 months compared to 40.8 months for people who received Herceptin and chemotherapy1 Median overall survival of almost five years is the longest observed to date in people […]

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 […]

Roche introduces a new fertility test for assessment of ovarian reserve for pregnancy

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The new Elecsys anti-Müllerian Hormone (AMH) fertility test increases the accuracy of ovarian reserve assessment compared to conventional methods Basel, 18 September 2014 – Roche today announced the launch of the Elecsys Anti-Müllerian Hormone (AMH) blood test, the first fully-automated AMH test for assessing a woman’s ovarian reserve. AMH is an important fertility marker used […]

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, […]

Roche to present latest oncology advances during ESMO 2014 Congress

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Presentations will include Results from the Phase III coBRIM study of Roche’s investigational MEK inhibitor cobimetinib plus Zelboraf compared to Zelboraf alone, potentially paving the way for a new standard of care Final survival data from the Phase III CLEOPATRA study of the combination of Perjeta, Herceptin and chemotherapy, further confirming the potential of this […]

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 […]

Roche’s RoACTEMRA receives EU approval for use in patients with early rheumatoid arthritis (RA)

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Treating RA patients with severe, progressive disease in the first two years after diagnosis (early RA) could prevent damage to joints and stop the disease from progressing1,2 RoACTEMRA with and without MTX achieved greater inhibition of structural joint damage compared with MTX alone in the early RA population1 Basel, 8 September 2014 – Roche (SIX: […]

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