Regulatory

Months of rumblings across Europe that the scheme to promote orphan drugs is being abused by drug firms to maximize profit instead of innovation have been heard. Those rumblings have now turned into shouts.

While approved in 2014, Europe's new regulation governing clinical studies is set to take effect in May-leaving interested parties only six more months to prepare for its arrival.

The country’s introduction of a new legal framework has it in sync with European law on clinical research.

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Ben Rotz, Director of Medical Transparency at Eli Lilly & Company discusses TransCelerate’s Data Transparency Initiative and position paper regarding patient data de-Identification and anonymization.

The "Cures" bill and PDUFA IV are the latest measures pushing for more systematic inclusion of patient views into drug development.

With patents for many NBCDs soon to expire, the need for regulatory guidance regarding follow-on versions of these products is crucial.

Understanding the benefits of this application route in helping companies withstand the hit of patent expiries.

Organized by country and topic area, the site also allows users to compare the requirements of two countries side-by-side.

The European Medicines Agency's public consultation on yet another aspect of transparency on clinical trials data has elicited further critical comment about excessive official secrecy.

This week, I attended CBI’s Expanded Access Programs conference in Philadelphia.

This month, the New England Journal of Medicine published the results of data sharing from pharmaceutical companies to researchers.

The European Forum for Good Clinical Practice says proposed restrictive access to clinical data would impede further progress in health research.

The European Union's struggle to bring its data protection rules into the 21st century continues...

In back-to-back announcements, Boehringer Ingelheim and Bayer HealthCare announced their pathway to allow access of clinical trial data to qualified researchers.

Although a broad compromise was reached in late December on the future shape of the European Union's clinical trials rules, there are still many details to be resolved.

Making clinical research data more widely available creates both opportunities and risks.

Compliance with reporting clinical trial results is low, and an even larger opportunity is being missed.

Integrating SAE handling into EDC systems reduces workload and increases accuracy and efficiency.

The EU Clinical Trials Directive may raise particular concerns for those considering running studies in CEE.

The potential of the biotechnology industry to provide blockbuster products is clearly demonstrated by examples like Enbrel (for the treatment of rheumatoid arthritis in adults and of active polyarticular-course juvenile chronic arthritis), Remicade (for the treatment of rheumatoid arthritis and Crohn's disease), and MabThera (for treatment of stage III-IV follicular lymphoma and CD20 positive diffuse large B-cell non-Hodgkin's lymphoma). The EvaluatePharma database1 indicates that at least 265 biotechnology products are currently marketed globally, more than doubling the figure from 1995. It is clear that there are many more blockbuster products to come, with an additional 100 biotechnology products currently in Phase III/preregistration, and a further 1000 reported to be in active development.