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
Reformulation specialist Lipella has an eye on numerous milestones for its proposed oral rinse liposomal formulation of tacrolimus, including the submission of a Phase IIb clinical trial investigational new drug application.
Alvotech has followed its European filing for a biosimilar to Regeneron’s Eylea (aflibercept) 2mg with acceptance for review from the US Food and Drug Administration for its AVT06 candidate.
A journey began eight years ago continues for Doc Generici – now rebranded as DOC Pharma – as it continues to diversify its offerings beyond conventional generic prescription pharmaceuticals.
A month after Vanda failed to win a trade secrets case against the US FDA corresponding to generic approvals for its brands Hetlioz and Fanapt, the originator has again fallen, this time to the agency and Teva in the alleged unlawful approval of the Israeli firm’s generic Hetlioz product.
Sanofi has bolstered its insulin offerings by bagging the first US FDA approval for a rapid-acting insulin aspart biosimilar, leaving several would-be sponsors in its wake.
Canada’s largest generics manufacturer Apotex will look to expand its channels to include health food stores, new professional channels including naturopathic doctors, and grocery retail channels, after acquiring Ontario-based natural health firm CanPrev for an undisclosed sum.