Dean Rudge
Senior Reporter
Dean has built up a wealth of knowledge on the global generics and biosimilar medicines industries in his five years with Generics bulletin. 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
Sandoz Eyes In-House GLP-1 Development – Apart From ‘Key’ APIs
With glucagon-like peptide 1 products to treat diabetes and obesity continuing to gather pace, Sandoz has expressed confidence that it is capable of bring such complex products to market using its vast array of in-house capabilities.
US Federal Circuit Will Not Stand In Way Of Gilenya Generics
ANDA sponsors targeting Novartis’s Gilenya have been informed by the US Court of Appeals for the Federal Circuit that at an ‘at-risk’ launch is possible, after the originator’s latest petition to the court was denied as it seeks a ruling from the US Supreme Court.
Pfizer Overcomes Attempt To Block Lexiscan ANDA
Injunctive relief has been provided against Hospira’s regadenoson ANDA product only until early October, allowing the US-based generics sponsor to close in on a potential launch.
Viatris Loses US Challenge To Januvia And Janumet Patents
Viatris’ attempts to deliver US generic versions of sitagliptin and sitagliptin/metformin ahead of patent expiry has failed for now, with an unfavorable judgment from a district court in West Virginia. More than 20 ANDA sponsors have opted to settle litigation with originator Merck.
Sandoz Delivers Denosumab Data As Biogen Sues On Tysabri
Having previously identified itself as the frontrunner in the race to launch a biosimilar to Amgen’s Prolia, Sandoz has now delivered positive confirmatory data, shortly after being sued in the US over its Polpharma-partnered proposed Tysabri biosimilar.
Gilenya Generics May Be Imminent Amid US Federal Circuit Snub
Are US Gilenya generics set to flood the US market? HEC Pharm is hoping so, following a favorable Federal Circuit denial. However, in a bid to maintain its monopoly and avoid a potential $300m hit to its top line, Novartis is taking its fight to the US Supreme Court.