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Washington correspondent Jill Wechsler reports on Janet Woodcock's explanation to Congress last week on the FDA’s lengthy and deliberative process for issuing important policy advisories on biosimilar naming, labeling and interchangeability.

IBM and ICON plc recently announced a collaboration to use the Watson system to enhance oncology clinical trial feasibility, recruitment and start up via Trial Matching.


Synowledge specializes in pharmacovigilance, regulatory affairs and information technology services to support biopharmaceutical companies with recording, analyzing and reporting adverse drug events.


The recent landmark international trial that was conducted at 23 cancer centers around the world including Memorial Sloan Kettering Cancer Center, New York, had results published last month.


The new results, published by The BMJ, contradict the original research findings that portrayed paroxetine as an effective and safe treatment for children and adolescents with major depression.

Much of the growth that has taken place in the top tier of CROs in recent years has been in the acquisition of some of the smaller, more innovative companies, rather than an increase in the number of compounds under study.


An analysis of 10.2 million adverse report records filed with the FDA along with survey of 123 health professionals by Tufts CSDD, found voluntary adverse drug event (ADE) reporting in the United States is incomplete, inaccurate, and inefficient.




New faces among the Pharma Industry rise the ranks.


ICON announced that it is applying IBM's Watson Clinical Trial Matching to its breast, lung, colon and rectal cancer trials.


Certara® and Paidion Research, announced a new partnership to address the challenges inherent in pediatric drug development.


ACRP believes the arbitrary two-years experience generally required throughout the industry is contributing to a shortage of CRAs and negatively impacting efficiencies and quality in clinical research.

The analysis compared various manifestations between genotypes and to determine if correlations exist between TSC symptoms and the TSC gene mutation.



Medidata, a global provider of cloud-based solutions for clinical research in life sciences, announced that its Clinical Cloud platform has been adopted by Walvax Biotechnology.

We all need help sometimes. For pharmaceutical companies, this often comes in the form of a reliable and competent contract research organization.


CRO embarks on the company’s largest-ever federal project.

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