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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 […]

FDA Accepts Amgen’s Biologics License Application For LDL Cholesterol-Lowering Medication Evolocumab

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THOUSAND OAKS, Calif., Nov. 10, 2014 /PRNewswire/ — Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review Amgen’s Biologics License Application (BLA) for evolocumab for the treatment of high cholesterol. Evolocumab is an investigational fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), a […]

Interim Data from Proof-of-Concept Study of Merck’s Investigational Hepatitis C Treatment Grazoprevir/Elbasvir in Combination with a Nucleotide Inhibitor (C-SWIFT study) Presented at The Liver Meeting®

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Merck Plans to Initiate Phase 2 C-CREST Program to Evaluate Merck’s Triple Combination of Grazoprevir/Elbasvir with MK-3682 (formerly IDX21437), a Novel Nucleotide Inhibitor, in Q1 2015 BOSTON, November 9, 2014–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the presentation of interim data from the C-SWIFT study exploring the potential […]

New Studies Investigating the Use of KEYTRUDA® (pembrolizumab), Merck’s Anti-PD-1 Therapy, in Advanced Melanoma Compared to Chemotherapy, in Classical Hodgkin Lymphoma and in Triple Negative Breast Cancer, to be Presented for the First Time

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By Year End, Data on KEYTRUDA in Seven Tumor Types Will Have Been Presented WHITEHOUSE STATION, N.J., November 6, 2014 –(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that in November and December, data will be presented for the first time investigating the use of KEYTRUDA® (pembrolizumab) – the […]

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 […]

North Wales first in Europe to connect cardiology departments with GE Healthcare’s Centricity Cardio Enterprise solution

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GE Healthcare supporting a number of European hospitals to improve efficiency and patient-care via innovative integrated care solutions Birmingham, 4 November 2014 – GE Healthcare is sharing information on several partnerships focusing on integrated care at EHI Live on the 4-5 November in Birmingham, UK. In North Wales, Betsi Cadwaladr University Health Board is to […]

Amgen Announces Top-Line Secondary Endpoint Results Of Phase 3 Trebananib TRINOVA-1 Trial In Patients With Recurrent Ovarian Cancer

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Study Failed to Meet Secondary Endpoint of Overall Survival THOUSAND OAKS, Calif., Nov. 4, 2014 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced the top-line secondary endpoint results of overall survival from the Phase 3 TRINOVA-1 trial in women with recurrent platinum-resistant ovarian cancer. The study, which evaluated trebananib plus paclitaxel versus placebo plus paclitaxel, did not […]

CHMP recommends label update for Esbriet in idiopathic pulmonary fibrosis, strengthening mortality benefit and reinforcing safety profile

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Pooled analysis of ASCEND and two CAPACITY phase III trials show 48 percent reduction in mortality risk at one year1 ASCEND data reinforces the Esbriet safety and efficacy profile1 Approximately 110,000 people in Europe have idiopathic pulmonary fibrosis (IPF), an irreversible, progressive, fatal lung disease2- 5 Only 20–40 percent of IPF patients survive five years […]

Amgen Announces Appointment Of R. Sanders Williams To Board Of Directors

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THOUSAND OAKS, Calif., Oct. 17, 2014 /PRNewswire/ — Amgen (NASDAQ: AMGN) today announced the appointment of R. Sanders Williams, M.D., president of Gladstone Institutes and Gladstone’s Robert W. and Linda L. Mahley Distinguished Professor. “We are pleased to welcome Dr. Sandy Williams to the Amgen Board,” said Robert A. Bradway, chairman and chief executive officer […]

FDA approves Esbriet (pirfenidone) for the treatment of idiopathic pulmonary fibrosis (IPF) in the United States

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Approximately 100,000 people in the United States have IPF, an irreversible and fatal lung disease1 Esbriet approved under FDA’s breakthrough designation program Basel, 16 October 2014 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has approved Esbriet (pirfenidone) as a treatment for idiopathic pulmonary fibrosis (IPF) […]

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