Theorem Clinical Research

Global News

Pharma & Biopharma Outsourcing Association formed

Monday, September 29, 2014 01:14 PM

Fifteen contract manufacturing organizations and contract development and manufacturing organizations (CMOs/CDMOs) have joined the Pharma & Biopharma Outsourcing Association (PBOA), a new nonprofit trade association that aims to help advance the industry's regulatory, legislative and business interests. 

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Daiichi Sankyo to acquire Ambit Biosciences for $410M

Monday, September 29, 2014 01:12 PM

Daiichi Sankyo, a Japan-based pharmaceutical, will acquire all outstanding common stock of Ambit Biosciences for $15 per share in cash through a tender offer, followed by a merger with a subsidiary of Daiichi Sankyo, or approximately $315 million on a fully diluted basis.

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BioMotiv, Takeda partner for medical innovation

Monday, September 29, 2014 01:06 PM

Takeda Pharmaceutical, a research-based global company headquartered in Osaka, Japan, has invested in BioMotiv, a therapeutic accelerator company associated with the Ohio-based Harrington Project for Discovery & Development, and they have partnered to identify and develop pioneering medical innovations.

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Cybersecurity in Global Trials

Monday, September 29, 2014 07:00 AM

Massive data breaches have dominated global headlines in recent months, and security experts predict this trend will continue.

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Medimmune, Cancer Research U.K. establish laboratory for biologic cancer medicines

Friday, September 26, 2014 03:24 PM

MedImmune, AstraZeneca’s global biologics R&D arm, and Cancer Research U.K., with its commercial arm Cancer Research Technology (CRT), have entered into an innovative collaboration to establish a joint laboratory in Cambridge, U.K. The new laboratory will focus on the discovery and development of novel biologic cancer treatments over an initial five-year period.

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Radiant/CRA enrolls 8,000 in hepatitis B vaccine study

Friday, September 26, 2014 03:23 PM

Radiant Research/Clinical Research Advantage (CRA), a Tempe, Ariz., wholly owned clinical trial site management organization, has completed enrollment for the Dynavax Technologies phase III clinical trial of HEPLISAV-B, an investigational adult hepatitis B vaccine.

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Thermo Fisher Scientific inks agreement with GlaxoSmithKline, Pfizer

Friday, September 26, 2014 03:01 PM

Thermo Fisher Scientific, a Waltham, Mass.-based healthcare equipment company, has inked an agreement with GlaxoSmithKline and Pfizer to develop a universal next-generation sequencing (NGS) oncology test for solid tumors that will serve as a companion diagnostic for multiple drug programs.

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BioLife Solutions adds Jason Acker, Anthony Davies to scientific advisory board

Thursday, September 25, 2014 03:00 PM

BioLife Solutions, a developer, manufacturer and marketer of proprietary clinical grade hypothermic storage and cryopreservation freeze media and precision thermal shipping products for cells and tissues, has hired two new additions to its scientific advisory board. The new members are Jason Acker, Ph.D., and Anthony Davies, Ph.D.

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Inovio expands HPV immunotherapy development to aerodigestive cancers

Thursday, September 25, 2014 02:51 PM

Inovio Pharmaceuticals has initiated a phase I clinical trial in patients with aerodigestive cancers. The trial will evaluate the safety, tolerability and immunogenicity of INO-3106. This immunotherapy targets human papillomavirus type 6 (HPV-6), which causes most aerodigestive cancers.

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Cytori restructures, cuts third of work force

Wednesday, September 24, 2014 01:27 PM

Cytori Therapeutics, a San Diego-based developer of cell therapies based on autologous adipose-derived regenerative cells (ADRCs), plans to restructure its operations and reduce costs.

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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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