Theorem Clinical Research

Drug Sponsors

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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Allied Minds launches Novare Pharmaceuticals

Wednesday, October 8, 2014 01:47 PM

Allied Minds, a Boston, Mass.-based science and technology development and commercialization company, has launched Novare Pharmaceuticals, a biotechnology company focused on developing therapeutic products that help the body replenish and rebuild itself using its own tissue through the modulation of Receptor for Hyaluronan Mediated Motility (RHAMM). Modulation of RHAMM also is of benefit in inflammatory diseases such as bronchopulmonary dysplasia (BPD).

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Actavis to acquire Durata Therapeutics

Monday, October 6, 2014 04:00 PM

Actavis, a global specialty pharmaceutical company based in Dublin, Ireland, and Durata Therapeutics, an innovative pharmaceutical company focused on the development and commercialization of novel therapeutics for patients with infectious diseases and acute illnesses, headquartered in Chicago, Ill., have entered into a definitive merger agreement.

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FDA seeks permanent injunction against Pharmaceutical Innovations

Monday, October 6, 2014 03:46 PM

The FDA is seeking a permanent injunction to stop Pharmaceutical Innovations, and its principal officer, Gilbert Buchalter, from manufacturing, marketing, selling and distributing medical products until they come into compliance with all applicable FDA requirements.

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Immutep to be acquired by Prima BioMed

Friday, October 3, 2014 11:04 AM

Immutep, an Orsay, France-based, late stage private biopharmaceutical company focused on immuno-oncology, has reached an agreement to be acquired by Prima BioMed, a Sydney, Australia-based developer of personalized immunocellular therapeutic products for cancer. Prima will pay up to approximately $28 million through a combination of cash, shares and warrants, subject to the achievement of certain performance milestones.

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Salix Pharmaceuticals, Cosmo Technologies terminate merger agreement

Friday, October 3, 2014 10:50 AM

Salix Pharmaceuticals, based in Raleigh, N.C., and Lainate, Italy-based Cosmo Pharmaceuticals have agreed to terminate their previously-announced merger agreement pursuant to which Salix would have combined with, and become a wholly-owned subsidiary of, Cosmo Technologies, a subsidiary of Cosmo Pharmaceuticals. Effective immediately, Salix will make a $25 million payment to Cosmo.

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BioNTech, Ganymed Pharmaceuticals open research headquarters in Germany

Thursday, October 2, 2014 02:14 PM

BioNTech and Ganymed Pharmaceuticals, two German biotechology companies, have opened a 108,000-square-foot headquarters and research facility. The new facility brings together 300 employees and is located near academic institutions, hospitals and cancer research institutions.

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Baxter to form new innovation and R&D center for biopharmaceuticals

Wednesday, October 1, 2014 01:26 PM

Baxter International plans to form a new global innovation and R&D center in Cambridge, Mass., for Baxter's biopharmaceuticals business, which is expected to become a separate, independent global company known as Baxalta in mid-2015.

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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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September

Today's fastest, most economical sponsors
Standout sponsors reveal how they shorten regulatory, clinical cycle times

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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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