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 Preparing for ICH-GCP E6(R2): A Former GCP Inspector Answers Your Compliance Questions
As this new rule will have an impact on all stakeholders in the clinical trials process – including study sponsors, contract research organizations (CROs), and investigator sites – it’s important that the guidelines are fully understood before GCP inspectors begin implementing them. I had a chance to speak with Gunnar Danielsson, a former GCP Inspector for the Swedish Medical Products Agency and European Medicines Agency, who now helps the industry and academia as an independent consultant.



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Pfizer and Celltrion Seek Biosimilar Interchangeability for Crohn’s Disease Drug
Pfizer recently reported that its biosimilar version of Johnson and Johnson’s Remicade, showed similar efficacy compared to the reference biologic in patients with moderate-to-severe Crohn’s disease.

Lack of Research Reproducibility Calls Scientific Integrity Into Question
The journal, Nature conducted a survey last year which found that over 70 percent of researchers have, at one time or another, been unable to reproduce another’s results by conducting the same experiments.

ImmusanT Releases Phase I Clinical Trial Results for Celiac Therapeutic
Massachusetts-based biotech company ImmusanT, has completed a Phase Ib clinical trial for its celiac disease vaccine, Nexvax2.

Antimicrobials Present on Healthy Skin Could Treat Atopic Dermatitis
In studying the differences in microbial makeup of healthy and non-healthy skin, researchers from the University of California San Diego School of Medicine found that some beneficial bacterial naturally produce antimicrobial peptides, which could be used to treat patients with atopic dermatitis.


 




 
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