Theorem Clinical Research

Amgen

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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Sorbent Therapeutics appoints two new board members

Thursday, June 19, 2014 02:27 PM

Sorbent Therapeutics, a biopharmaceutical company developing therapies for cardiovascular and renal diseases, has appointed Jay Shepard and William D. Waddill to the company's board of directors.

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Sangamo BioSciences appoints H. Stewart Parker to its board of directors

Thursday, June 19, 2014 01:57 PM

Sangamo BioSciences announced the appointment of H. Stewart Parker to the company's board of directors. Parker, who founded and was president and CEO of Targeted Genetics, brings more than 30 years of experience in the biotechnology industry, including 16 years of specific experience in cell and gene therapy.

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CWWeekly

September 15

WIRB-Copernicus Group acquires New England IRB

BBK Worldwide secures $3 million in private ἀnancingto accelerate its global and technological expansion

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The CenterWatch Monthly

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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The CenterWatch Monthly

July

IRB market consolidating rapidly
Private equity driving a new commercial ethical review landscape

Lessons learned from medical device trials
Smaller, faster, more flexible trials hold important insights for pharmaceutical innovation

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