Theorem Clinical Research

Drug Sponsors

CytRx launches discovery laboratory to develop anti-cancer drug platform

Thursday, October 16, 2014 08:31 AM

CytRx, a Los Angeles-Calif.-based biopharmaceutical R&D company specializing in oncology, has commenced operations at its new discovery laboratory in Freiburg, Germany. The new laboratory will conduct discovery and translational research to create drug candidates that utilize novel linker technologies that couple chemotherapeutic agents and proteins either inside the body or externally, and then concentrate drug in tumors.

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Impax to acquire Tower Holdings and Lineage Therapeutics

Wednesday, October 15, 2014 06:00 PM

Hayward, Calif.-based Impax Laboratories will acquire Tower Holdings, including operating subsidiaries CorePharma, based in Middlesex, N.J., Amedra Pharmaceuticals, based in Horsham, Penn., and Lineage Therapeutics, also based in Horsham, for $700 million in cash, subject to certain customary purchase price adjustments.

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Aastrom Biosciences to change name to Vericel, move headquarters to Massachusetts

Wednesday, October 15, 2014 05:30 PM

Aastrom Biosciences, a developer of patient-specific expanded cellular therapies for the treatment of severe diseases and conditions, plans to change its corporate name to Vericel and move its corporate headquarters from Ann Arbor, Mich., to Cambridge, Mass. The corporate name change is subject to the approval of Aastrom's shareholders. Aastrom will continue to maintain manufacturing facilities in Cambridge and Ann Arbor.

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Covance, Novartis collaborate to develop a clinical data warehouse

Wednesday, October 15, 2014 01:21 PM

Covance has entered an in-kind collaboration with Novartis Institutes for Biomedical Research (NIBR) to accelerate the development of a state-of-the-art clinical data warehouse designed to support data integration and meta-analysis for preclinical and clinical research.

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Endo to acquire Auxilium Pharmaceuticals for $2.6 billion

Friday, October 10, 2014 12:01 PM

Dublin, Ireland-based Endo International has agreed to acquire Chesterbrook, Pa.-based Auxilium Pharmaceuticals. Endo will acquire all outstanding common stock for $33.25 per share in a cash and stock transaction. The boards of directors of both companies have unanimously approved the transaction, valued at $2.6 billion, which includes the repayment and assumption of debt.   

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CSL Behring expands manufacturing capabilities

Thursday, October 9, 2014 11:32 AM

CSL Behring, a King of Prussia, Pa.-based provider of plasma protein therapeutics, has announced a multi-year, $450-million two-site global capacity expansion, the latest in a series of recent production expansions to meet the growing need for therapies used to treat patients with rare and serious medical disorders around the world. 

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Bristol-Myers Squibb, Novartis collaborate on NSCLC

Thursday, October 9, 2014 10:00 AM

Bristol-Myers Squibb has established a clinical trial collaboration to evaluate the safety, tolerability and preliminary efficacy of combining Bristol-Myers Squibb’s investigational PD-1 immune checkpoint inhibitor Opdivo (nivolumab) with three molecularly targeted oncology therapies (Zykadia (ceritinib), INC280 and EGF816) from Novartis. Novartis will conduct two phase I/II studies focused on non-small cell lung cancer (NSCLC).

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Bristol-Myers Squibb, MD Anderson Cancer Center collaborate

Thursday, October 9, 2014 09:30 AM

Bristol-Myers Squibb and the University of Texas MD Anderson Cancer Center have formed a novel clinical research collaboration to evaluate multiple immunotherapies, including Opdivo (nivolumab), Yervoy (ipilimumab) and three early-stage clinical immuno-oncology assets from Bristol-Myers Squibb, as potential treatment options for acute and chronic leukemia as well as other hematologic malignancies.

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DPx to expand facility in North Carolina, add 488 jobs

Thursday, October 9, 2014 08:00 AM

DPx, the “umbrella name” for Patheon’s three business units specializing in pharmaceutical services, fine chemicals and proprietary products and technologies, will expand operations in Pitt County, N.C. The company plans to create 488 jobs in Greenville, N.C. by the end of 2019 and invest $159 million to increase the site’s capabilities, as well as modernize the site and develop energy efficiency programs at the facility.

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Teva announces results of strategic review of core specialty therapeutic areas

Wednesday, October 8, 2014 01:49 PM

Teva Pharmaceutical Industries has identified 14 pipeline projects for discontinuation or divestment as part of its strategic review of core therapeutic areas for the company. These projects amount to more than $150 million in R&D costs in 2015 and in excess of $200 million for each of 2016 and 2017.

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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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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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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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