In the first of a two-part interview with the Pink Sheet, an expert from the Swiss drug regulator explains why international collaborations are “the future” and outlines the agency’s “extremely positive” experience since joining the Project Orbis initiative three years ago.
The US-led Project Orbis was initiated by the Food and Drug Administration in May 2019, with the aim of establishing a framework for international regulators to concurrently review filings for cancer drugs.
Its ultimate goal was to allow patients with cancer to receive earlier access to innovative oncology medicines by avoiding delays...
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The health technology assessment institute, NICE, said the price BioMarin was asking for Brineura was too high, even though its appraisal committee applied a cost-effectiveness threshold ten times higher than usual.
Vertex and Biogen are working with the Dutch government to ensure access for eligible patients.
The pharmaceutical industry is edging closer to EU-wide clarity on how the bloc’s data privacy rules can be applied consistently to clinical trials and pharmacovigilance activities.
A government-backed program is working on improving the ability to run dementia clinical trials in the UK, and access to trials for participants.
New guidance from the National Pharmaceutical Regulatory Agency responds to the medicines shortages crisis that Malaysia experienced a few years ago.
Vertex and Biogen are working with the Dutch government to ensure access for eligible patients.
Aurobindo is confident its planned Lannett acquisition will meet US FTC standards after an attempt to acquire Sandoz assets was nixed in 2020. The deal also could widen Aurobindo’s US manufacturing presence.
