Theorem Clinical Research

Drug Sponsors

Bayer plans to focus entirely on life science businesses

Thursday, September 18, 2014 01:27 PM

Bayer has announced that it intends, in the future, to focus entirely on its life science businesses—HealthCare and CropScience—and float MaterialScience on the stock market as a separate company. In this way Bayer is positioning itself as a human, animal and plant health company. The supervisory board unanimously has approved the board of management's plans.

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AstraZeneca, Eli Lilly ink agreement for AZD3293 for Alzheimer’s disease

Wednesday, September 17, 2014 02:28 PM

AstraZeneca and Eli Lilly have inked an agreement to jointly develop and commercialize AZD3293, an oral beta secretase cleaving enzyme (BACE) inhibitor currently in development as a potential treatment for Alzheimer’s disease.

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Endo International seeks to acquire Auxilium Pharmaceuticals for $2.2B

Wednesday, September 17, 2014 02:12 PM

Endo International, a Dublin-based global specialty healthcare company, has delivered an unsolicited proposal to acquire all of the outstanding shares of Chesterbrook, Pa.-based Auxilium Pharmaceuticals for a per share consideration of $28.10, in a cash and stock transaction valued at $2.2 billion.

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Novartis to open Center for Advanced Cellular Therapeutics at University of Pennsylvania

Monday, September 15, 2014 12:29 PM

The University of Pennsylvania’s alliance with Novartis has unveiled plans for the construction of a first-of-its-kind Center for Advanced Cellular Therapeutics (CACT) on the Penn Medicine campus in Philadelphia.

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Livongo Health launched

Wednesday, September 10, 2014 03:00 PM

Livongo Health, a California-based consumer digital health company, has launched with a vision to empower people with chronic conditions to live better through the combined power of technology, real-time personalized information and support from a chosen care team.

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Hyperion to terminate DiaPep277 diabetes program after discovering serious misconduct by Andromeda employees

Tuesday, September 9, 2014 12:34 PM

Calling it “an unprecedented level of deceit,” Hyperion Therapeutics president and CEO Donald J. Santel told an analyst conference call the company is terminating its DiaPep277 development program for newly diagnosed type 1 diabetes.

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AbbVie, Calico launch R&D collaboration for age-related diseases

Thursday, September 4, 2014 12:35 PM

Chicago-based AbbVie and Calico, a California-based Google-founded R&D company, have announced a novel R&D collaboration intended to help the two companies discover, develop and bring to market new therapies for patients with age-related diseases, including for neurodegeneration and cancer.

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Johnson & Johnson to accelerate Ebola vaccine program in collaboration with NIH

Thursday, September 4, 2014 12:29 PM

Johnson & Johnson has committed to accelerate its Ebola vaccine program in collaboration with the NIH. J&J will fast-track the development of a promising new combination vaccine regimen against Ebola and broadly collaborate to deliver immediate relief aid to address the current Ebola outbreak.

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HHS contracts with Mapp Biopharmaceutical to develop ZMapp for Ebola

Thursday, September 4, 2014 12:22 PM

The development of a medication to treat illness from Ebola will be accelerated under a contract with the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR).

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Exelixis cuts 70% of employees following failed pivotal trial

Wednesday, September 3, 2014 12:41 PM

Exelixis, a California-based biopharmaceutical company developing small molecule therapies for cancer, has announced top-line results from the final analysis of COMET-1, the phase III pivotal trial of cabozantinib in men with metastatic castration-resistant prostate cancer (mCRPC) whose disease progressed after treatment with docetaxel as well as abiraterone and/or enzalutamide. The trial did not meet its primary endpoint of demonstrating a statistically significant increase in overall survival (OS) for patients treated with cabozantinib as compared to prednisone.

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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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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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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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