Clinical / R&D
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Latest From Research & Development
The BioIndustry Association has laid out its wishlist for the next UK administration, including deep regulatory alignment with the EU after Brexit, a more “flexible” approach to health technology assessment appraisals of new drugs, and support for R&D.
India has taken strides towards creating a supportive environment for its nascent gene therapy research, but the R&D and regulatory infrastructure is still evolving amid concerns over potential product costs.
Provention Bio’s teplizumab, a potentially game-changing treatment for preventing or delaying type 1 diabetes, is one of three investigational products to be newly accepted onto the European Medicines Agency’s popular priority medicines scheme.
Last week the World Trade Organization’s TRIPS Council discussed transparency in medicine pricing, including R&D costs.
New guidelines on good clinical practice for advanced therapies address the constraints most often encountered by developers conducting trials for these types of treatments.
US FDA is encouraging common mechanisms of drug testing to enable pharma industry collaboration and avoid redundancy; Pazdur notes that there are many similar PD-1 drugs.
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