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
ANI Pharmaceuticals says it has delivered an “exceptionally strong first quarter,” with total sales reaching over $197m, amid plans to kick off a Phase IV clinical trial for Cortrophin Gel for acute gouty arthritis later this year.
Acadia’s Nuplazid for hallucinations and delusions associated with Parkinson’s disease psychosis is looking safe from generic competition – for now – until well into the next decade, following a favorable infringement and validity decision by a US district court.
Gedeon Richter’s CEO has urged analysts and the firm itself to give more attention to its “unfairly neglected” General Medicines division – which includes both generics and licensed-in innovative products – during the Hungarian firm’s first-quarter earnings call.
Rejecting Amgen’s challenges on the grounds of anticipation and obviousness, Canada’s Federal Court has issued an injunction against the biosimilars firm until patent expiry in March 2027.
Eight more ANDA filers remain in play challenging patents shielding Esperion’s Nexletol (bempedoic acid) after Micro Labs deal out litigation via a settlement agreement.
Viatris continues to make progress on remediation at the firm’s stricken manufacturing facility in Indore, India, following a warning letter and import alert delivered at the tail end of 2024.