Theorem Clinical Research

Global News

WILEX subsidiary Heidelberg Pharma, Roche extend collaboration

Thursday, October 16, 2014 09:00 AM

Wilex’s Germany-based subsidiary Heidelberg Pharma and Roche have extended an existing 2013 license agreement to apply the antibody drug conjugate (ADC) technology for the further development of Roche antibodies. The aim is to identify and develop novel Antibody Targeted Amanitin Conjugates (ATACs) based on Heidelberg Pharma's patented technology to couple α-Amanitin to antibodies.

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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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MHRA sets up ‘one-stop shop’ for advice on regenerative medicine

Thursday, October 16, 2014 08:00 AM

The U.K.’s Medicines and Healthcare products Regulatory Agency’s (MHRA) Innovation Office has set up a portal for all regulatory queries concerning regenerative medicines, the Regenerative Medicines Regulatory Advice Service. A “one-stop shop” service, it will provide a single point of access from the four regulators in the field: the Human Tissue Authority (HTA), the Human Fertilization and Embryology Authority (HFEA), Health Research Authority (HRA) and the Medicines and Healthcare Products Regulatory Agency (MHRA), which will provide a coordinated single response service for free regulatory advice.

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Astellas, Harvard Medical School investigator collaborate

Thursday, October 16, 2014 07:30 AM

Astellas Pharma, based in Tokyo, Japan, has formed a research collaboration with an investigator at Harvard Medical School in Boston, Mass., focused on discovering the pathologic mechanism for retinitis pigmentosa and identification of new therapeutic targets. Astellas and Harvard aim to provide a new treatment option, possibly gene therapy, to retinitis pigmentosa patients who have difficulty maintaining good vision.  

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Exostar, BT partner

Thursday, October 16, 2014 07:00 AM

Exostar, a Herndon, Va.-based provider of secure, cloud-based solutions that improve collaboration, information sharing and supply chain management for communities of partners, has become a specialist member of the BT for Life Sciences partner ecosystem. Exostar’s secure identity and access management (IAM) and enterprise federation solutions now can be paired with BT’s Workbench Informatics solution for scientists.

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CCRM, RepliCel to partner on development of cell therapies for tendon repair

Thursday, October 16, 2014 06:30 AM

RepliCel Life Sciences, a Vancouver-based clinical stage regenerative medicine company focused on the development of autologous cell therapies, is the newest member of the Center for Commercialization of Regenerative Medicine’s (CCRM) industry consortium, a Canadian not-for-profit organization.

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Bristol-Myers Squibb, Pharmacyclics and Janssen collaborate

Wednesday, October 15, 2014 08:00 PM

Bristol-Myers SquibbPharmacyclics and Janssen R&D have entered into a clinical trial collaboration agreement to evaluate the safety, tolerability and preliminary efficacy of BMS’ investigational PD-1 immune checkpoint inhibitor Opdivo (nivolumab) in combination with Imbruvica (ibrutinib), an oral Bruton's tyrosine kinase (BTK) inhibitor co-developed and co-marketed by Pharmacyclics and Janssen.

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Alexion, Cincinnati Children’s launch rare disease innovation fund

Wednesday, October 15, 2014 06:30 PM

Alexion Pharmaceuticals, a Cambridge, Mass.-based developer of breakthrough therapies for patients with severe and life-threatening rare diseases, and Cincinnati Children’s Hospital Medical Center have established the Alexion Rare Disease Innovation Fund for the advancement of research in rare disease.

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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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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

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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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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