Theorem Clinical Research

Roche

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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Roche to acquire Santaris Pharma for $450M

Monday, August 4, 2014 02:14 PM

Roche has agreed to acquire Santaris Pharma, a privately held biopharmaceutical company based near Copenhagen, Denmark. Santaris Pharma has pioneered its proprietary Locked Nucleic Acid (LNA) platform that has contributed to an emerging era of RNA-targeting therapeutics. This new class of medicines has the potential to address difficult to treat diseases in a range of therapeutic areas.

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Pfizer, Roche join ADDPLAN DF Consortium

Monday, August 4, 2014 02:12 PM

Pfizer and Roche have joined the ADDPLAN DF Consortium. The consortium was founded in 2013 by Novartis, Janssen PharmaceuticalsEli Lilly and Aptiv Solutions, an Icon company, to lead the design and implementation of adaptive trials. The goal of the ADDPLAN DF Consortium is to develop methodologies and execution technologies that improve dose-selection, which remains a major barrier to resolving high failure rates in phase III trials.

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Alzheimer's disease market forecast to reach nearly $12B by 2023

Monday, July 21, 2014 03:29 PM

Decision Resources Group has found the market for Alzheimer's disease (AD) therapies will more than triple, reaching nearly $12 billion by 2023, largely due to the forecasted launch of the first disease-modifying therapies (DMTs), a landmark event in AD treatment.

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CWWeekly

September 29

WCG sees ePharmaSolutions’ clinical trial portal as the next step in the data evolution, company mission

Cutting-edge advertising can ‘break through the clutter’ for successful patient recruitment

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The CenterWatch Monthly

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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The CenterWatch Monthly

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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