Theorem Clinical Research

Amgen

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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ABPI establishes Inward Investor Group

Wednesday, July 23, 2014 10:45 AM

The Association of the British Pharmaceutical Industry (ABPI) has established a new Inward Investor Group to demonstrate the importance of inward investment to the U.K. and the global mobility of such investment. The group also will work toward cultivating a favorable environment for pharmaceutical companies to invest in the U.K.

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Bellerophon Therapeutics names Jonathan Peacock chairman and CEO

Wednesday, July 2, 2014 11:37 AM

Bellerophon Therapeutics, a clinical stage biotherapeutics company, has announced that Jonathan Peacock has been appointed chairman and CEO. Peacock assumes the role from Daniel Tasse, chairman and CEO of Ikaria, who was interim chairman and CEO of Bellerophon since the company's spin-out from Ikaria in February. Tasse will continue as a member of the board of Bellerophon.

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Amgen receives FDA Breakthrough Therapy Designation for Blinatumomab in ALL

Wednesday, July 2, 2014 11:04 AM

The FDA has granted Breakthrough Therapy Designation to Amgen’s investigational bispecific T cell engager (BiTE) antibody blinatumomab, for 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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October 20

Toronto Star, with FDA data, exposes weaknesses in Health Canada's clinical trial, inspection oversight

Crowdsourcing effort aims to fund updated online social media guide for sponsor interaction with patients

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The CenterWatch Monthly

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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August

Reality of costs and impact rain on Sunshine Act
Concerns mount over compliance burden on CROs, sponsors, unanticipated consequences for research

Cloud computing expanding into all areas of clinical trial conduct
Benefits outweigh the complexities, challenges of finding right vendors

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