Dean has built up a wealth of knowledge on the global generics and biosimilar medicines industries since joining Generics Bulletin in 2013. He specializes in commercial and legal issues, writing in-depth analyses of corporate strategy and getting under the skin of patent infringement proceedings and other litigation. He attends investor and regulatory meetings with business leaders, favoring the investor days with their focus on corporate strategy. In his spare time, Dean enjoys visiting museums and playing five-a-side football.
Latest from Dean Rudge
The Court of Appeal in London has upheld a key UK patent shielding Astellas’ Xtandi, rejecting claims by a trio of generic drugmakers that it was obvious after finding that the generics firms’ expert analysis was tainted by hindsight.
Sun Pharma is facing renewed scrutiny after a scathing US Food and Drug Administration inspection at its Halol facility in Gujarat painted a grim picture of a facility operating in disregard of basic pharmaceutical safety standards.
Novartis has failed to secure a court order to stop MSN from launching a generic Entresto, and has also seen an earlier temporary ban lifted, potentially opening the market to competition before a final decision on a US patent dispute.
Bio-Thera is one step closer to launching a biosimilar to Johnson & Johnson’s Simponi in the US, following FDA acceptance of its BAT2506 proposed golimumab candidate.
Krka has reported its strongest-ever half-year results, surpassing €1bn in sales and growing EBITDA by 8%. Solid performance across most regions, particularly Eastern and Central Europe, supported stable margins and a positive full-year outlook.
The Federal Circuit has temporarily blocked MSN from launching a generic version of Entresto, granting Novartis short-term relief while it reviews the company’s emergency Rule 8 motion for a longer injunction.