Theorem Clinical Research

Amgen

International GPCR Consortium formed with pharma, academia partners

Wednesday, October 29, 2014 01:32 PM

The generation of high-resolution pictures of hundreds of medically important proteins known as G-protein coupled receptors (GPCRs) will be the goal of a new international partnership. Called the GPCR Consortium, the nonprofit initiative brings together pharmaceutical companies and research institutes from three continents to advance GPCR research for drug development.

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Amgen outlines strategy, will cut up to 4,000 jobs

Wednesday, October 29, 2014 01:28 PM

Amgen has outlined the company's strategy, growth objectives and capital allocation plans, and provided financial guidance for 2015. In addition to the approximately 2,900 positions already set to be eliminated by the end of 2015, an additional 600 to 1,100 jobs will be cut.

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Cancer Innovation forum calls for improving cancer research ecosystem

Monday, October 27, 2014 12:58 PM

Accelerating the delivery of promising new cancer treatments depends on one critical requirement—ensuring patients are actively involved in the cancer research and drug development process from beginning to end.

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Amgen reports positive results of two phase III studies of evolocumab

Thursday, October 2, 2014 12:46 PM

Amgen has announced data from two phase III studies, RUTHERFORD-2 and TESLA, that showed treatment with evolocumab, a novel investigational low-density lipoprotein cholesterol (LDL-C)-lowering medication, resulted in a statistically significant reduction in LDL-C compared to placebo in patients with different types of familial hypercholesterolemia (FH). FH is an inherited condition caused by a gene mutation, which leads to high levels of LDL-C, or "bad" cholesterol, and premature cardiovascular disease.

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Amgen submits BLA for investigational BiTE immunotherapy blinatumomab

Thursday, September 25, 2014 02:55 PM

Amgen has submitted a Biologics License Application (BLA) to the FDA seeking approval for its investigational bispecific T cell engager (BiTE) antibody construct, blinatumomab. The BLA is for the treatment of adults with Philadelphia-negative (Ph-) relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL), a rapidly progressing cancer of the blood and bone marrow.

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Bay Area BioEconomy Initiative appoints Pablo Cagnoni to steering committee

Friday, September 12, 2014 01:01 PM

The Bay Area BioEconomy Initiative (BAB) has named Pablo J. Cagnoni, M.D., president of Onyx Pharmaceuticals, to its steering committee. Onyx, an Amgen subsidiary, is engaged in the development and commercialization of innovative therapies to improve the lives of people with cancer.

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Report: Data sharing measures improving

Wednesday, September 10, 2014 02:45 PM

Citeline, an Informa business unit, has reported that clinical trial transparency, also known as responsible data sharing, is in a much healthier state than shown in previous studies.

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Positive results released for Amgen’s phase III study of AMG 416

Thursday, August 21, 2014 10:24 AM

Amgen has announced that a second placebo-controlled, phase III study evaluating AMG 416 for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD), receiving hemodialysis, met its primary and all secondary endpoints.

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Group of 19 institutional investors seeks support for biosimilars from top biopharma companies

Thursday, August 14, 2014 02:34 PM

Don’t bad mouth biosimilars—they are needed to help hold down skyrocketing drug costs.

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Amgen to cut up to 3,000 jobs, most in U.S., close facilities

Wednesday, July 30, 2014 11:42 AM

Amgen has announced a restructuring plan to invest in continuing innovation and the launch of its new pipeline molecules, while improving cost structure.

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October 27

NIH’s I-Corps boot camp aims to transform researchers into better businesspeople before they launch products

Covance, Frenova form partnership to share patient databases, find effective treatments for renal disease

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The CenterWatch Monthly

October

CROs driving changes in patient recruitment
Data- and tech-aided enrollment services a competitive advantage

Trials with in-home nurses poised to grow
Higher expense, but may improve recruitment and retention for select trials

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September

Today's fastest, most economical sponsors
Standout sponsors reveal how they shorten regulatory, clinical cycle times

From the trenches: Sites' eye view of state of the industry
CW’s first site focus groups uncover frustration with 'progress,' but a passion for their mission

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