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
Partners Dong-A ST and Meiji Seika Pharma have demonstrated their credentials in the US biosimilar market, bagging a US Food and Drug Administration approval for their biosimilar Stelara product that will be commercialized by Accord Healthcare.
Teva resolved two US Department of Justice civil suits accusing the firm of violating the US Anti-Kickback Statute and the False Claims Act by allegedly conspiring to fix the price of three generic drugs and paying Medicare patients’ copays for its multiple sclerosis brand product Copaxone.
Teva has resolved a pair of civil US Department of Justice lawsuits accusing the firm of violating the US Anti-Kickback Statute and the False Claims Act through its alleged conduct conspiring to fix the price of three generic drugs and for allegedly paying Medicare patients’ copays for its multiple sclerosis brand Copaxone.
In the space of a few days, all four generics manufacturers that had successfully petitioned for a re-examination of a key patent shielding Novo Nordisk’s mega blockbuster Ozempic have reached settlement agreements terminating their challenges.
Hyloris recognized that the suspension of its shares as part of a broader business fallout has “created uncertainty and temporarily impacted management and organizational focus,” as it got another commercial deal over the line for its Maxigesic IV (paracetamol/ibuprofen) solution for infusion.
Fresenius Kabi is facing up to a patent-litigation suit over its proposed biosimilars to Amgen’s Prolia/Xgeva brands – although a prior lawsuit involving biosimilar sponsor Sandoz concluded with a settlement agreement.