Amgen

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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WIRB Copernicus Group

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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Amgen joins NCI to accelerate development of personalized cancer treatments

Tuesday, June 17, 2014 10:26 AM

Amgen will collaborate with the National Cancer Institute (NCI), part of the NIH, and other public and private sector partners, on the Lung Master Protocol (Lung-MAP), a new clinical trial program that will use biomarker-driven research and genomic profiling to match squamous cell lung cancer patients to investigational treatments based on their individual cancer profiles. Lung-MAP is the first trial of its kind to study a large number of rare lung cancer subsets under one trial protocol.

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Kite Pharma appoints William Y. Go, Jeff Aycock senior directors

Thursday, June 12, 2014 12:54 PM

Kite Pharma, a clinical-stage biopharmaceutical company focused on developing engineered autologous T cell therapy (eACT) products for the treatment of cancer, has expanded Kite's R&D leadership team with the appointments of William Y. Go, M.D., Ph.D., as senior director, Clinical Development, and Jeff Aycock as senior director, Clinical Operations.

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CWWeekly

August 25

Verizon Communications enters clinical trial space with technology, network, and cloud and data services

Sponsors look to the power of genomic profiling to screen, enroll patients in trials for targeted therapies

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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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