Theorem Clinical Research

Roche

Cardiorentis, Roche collaborate on Ularitide

Friday, October 17, 2014 12:49 PM

Cardiorentis, a Switzerland-based, privately held biopharmaceutical company, is collaborating with Roche to establish the therapeutic efficacy and safety of Ularitide, the company's investigational drug for acute heart failure (AHF). Cardiorentis will incorporate Roche's advanced in vitro diagnostic tests into its TRUE-AHF phase III study to characterize the pharmacological properties of Ularitide, evaluate its benefit-risk profile and the appropriate clinical application in patients.

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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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PPD acquires X-Chem

Tuesday, October 7, 2014 10:30 AM

Pharmaceutical Product Development (PPD), a Wilmington, N.C.-based CRO, has exercised its option to acquire the remaining minority ownership interest of X-Chem. X-Chem, a biotechnology company based in Waltham, Mass., will continue to operate as a biotechnology company with its entire existing staff, including its management team led by CEO and founder Richard W. Wagner, Ph.D., along with executive management team members Diala Ezzeddine, Ph.D., chief business officer; Matthew Clark, Ph.D., sr. vice president of research; and Lee Babiss as chairman of the board.

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NICE to seek greater access to clinical trial data when appraising drugs

Thursday, September 11, 2014 01:32 PM

NICE will ask for access to clinical trial data from European regulatory authorities if pharmaceutical companies fail to supply all relevant data. The move follows calls for increasing transparency from pharma companies and comes after Roche was criticized for its handling of data for the pandemic flu drug Tamiflu.

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Report: Data sharing measures improving

Wednesday, September 10, 2014 02:45 PM

Citeline, an Informa business unit, has reported that clinical trial transparency, also known as responsible data sharing, is in a much healthier state than shown in previous studies.

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TransCelerate releases recommended approach for protecting personal data in Clinical Study Reports

Wednesday, September 3, 2014 08:20 AM

TransCelerate BioPharma has developed a recommended approach for protecting personal data in Clinical Study Reports (CSRs) shared with researchers, patients and others.

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Roche to acquire InterMune for $8.3 billion

Monday, August 25, 2014 02:02 PM

Roche and InterMune have entered into a definitive merger agreement under which Roche will fully acquire InterMune for $74 per share in cash, for a total transaction value of $8.3 billion on a fully diluted basis.

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Roche, Garvan Institute of Medical Research partner

Wednesday, August 20, 2014 01:22 PM

Roche and the Australia-based Garvan Institute of Medical Research are collaborating to develop new technologies for targeted epigenomic analysis using DNA sequencing. Genomics is a rapidly evolving field with a focus on realizing the potential use of sequencing information in patient diagnosis and treatment.

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FDA approves Avastin to treat aggressive and late-stage cervical cancer

Friday, August 15, 2014 12:43 PM

The FDA has approved a new use for Avastin (bevacizumab) to treat patients with persistent, recurrent or late-stage (metastatic) cervical cancer.

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Ventana, Quintiles ink agreement for companion diagnostic services in China

Thursday, August 7, 2014 10:00 AM

Ventana Medical Systems, a member of the Roche Group, has inked a new agreement with Quintiles to offer College of American Pathology (CAP) standard companion diagnostic testing services in China for pharmaceutical and biotech companies conducting early phase clinical trials. China is one of the only countries in the world that requires all patient samples be tested in China, even those used in clinical trials.

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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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