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
This month, long-awaited new pricing measures in Canada will come into force, while several trials will either kick off or end, including a liability opioids case involving Teva in San Francisco and Hatch-Waxman litigation over Otsuka/Lundbeck’s Rexulti.
The AMR Industry Alliance has formalized its years-old Common Antibiotic Manufacturing Framework by publishing an antibiotic manufacturing standard, in what it terms a “groundbreaking step” in the drive for responsible manufacturing.
Cigna has responded to several questions from the insurer/payer side on the potential effect of multiple biosimilar Humira products launching in 2023 and beyond.
China’s HEC Pharm, the last ANDA filer for fingolimod standing in patent litigation, has won a key invalidity challenge against a dosing-regimen patent shielding the multiple sclerosis treatment. However, the Federal Circuit was split on whether it had applied a heightened standard for negative claim limitations.
Ahead of entering the planned commercialization stage for its first biosimilar product, German biotech Formycon has revealed a series of major announcements, including that it has beefed up its pipeline with an additional two new assets. Meanwhile, it expects to soon find a commercialization partner for its proposed Stelara biosimilar.
India’s Biocon has issued a response after a local English-language daily reported allegations that the company and one of its officials was involved in bribing the Joint Drugs Controller to waive Phase III clinical trial data for its proposed NovoLog (insulin aspart) biosimilar.