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BioBrief – November 2022

Our newsletter for the life sciences sector

Winter is coming!

The last year has seen a fall in biotech stocks, with investor interest cooling and a falling-off in demand for IPOs. 
 
A key strategic issue for many seeking partnerships with Big Pharma or other sources of funding is the robustness of the patent portfolio.  IP issues feature in two contributions to this month’s BioBrief: in the first, my colleague Dr Amanda Easey and I present a videocast on the recent decision of the Patents Court to uphold the validity of an important Astellas patent protecting their blockbuster product Mirabegron.  In the second, I summarise the controversial aspects of the debate currently taking place at the WTO level concerning patent waivers on diagnostics, vaccines and therapies for COVID-19 infection. 
 
Demystifying regulatory complexity is a topic covered by two of this month’s authors.  Dr Lisa Page analyses the In Vitro Diagnostic Medical Devices Regulation and Dr Amanda Easey summarises the UK’s new approach to the regulatory approval hurdles faced by biosimilar medicines.

Finally, our immigration colleague Pat Saini describes the UK government’s recently announced changes to its Immigration Rules, including the launch of the new Global Business Mobility, High Potential Individual, and Scale-up routes.
 
As ever, please do not hesitate to get in touch directly with any of the authors in this edition of BioBrief, who will be delighted to receive your comments and happy to advise further on any of the issues discussed in this edition.

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