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Clinical / R&D

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Latest From Research & Development

UK BIA Targets Next Government With ‘Biotech Manifesto’

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.

United Kingdom Brexit

Gene And Cell Therapies In Asia: Indian Environment Evolving But Multiple Issues Unresolved

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.

Asia Pacific India

EMA Accepts First Diabetes Drug Onto PRIME

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.

Drug Review Research & Development

WTO Price Transparency Talks Face Resistance From Developed Countries

Last week the World Trade Organization’s TRIPS Council discussed transparency in medicine pricing, including R&D costs.

South Africa Intellectual Property

Thumbs Up For EU Guidance On Advanced Therapy Trials

New guidelines on good clinical practice for advanced therapies address the constraints most often encountered by developers conducting trials for these types of treatments.

Clinical Trials Regenerative Medicine

FDA's Pazdur Advocates Platform Trials For Cancer Drug Development

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.

Clinical Trials Cancer
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