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Dean Rudge

Senior Reporter

London, UK

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

Fresenius Kabi Weighs Potential Of Warning Letter For Melrose Park

Fresenius Kabi discussed the latest around the potential of an FDA warning letter at its key injectables plant in Melrose Park, after earlier this year confirming that no product launches from the site were anticipated in 2021.

Manufacturing FDA

Coherus Distances Itself From Biosimilar Interchangeability

Coherus BioSciences has had its say on the prospect of interchangeability for Humira biosimilars, shortly after Boehringer Ingelheim announced positive data from a ‘first-of-its-kind’ switching study.

Biosimilars Strategy

Teva Envisions ‘Significant’ Wait For US Price Fixing Cases

Teva said it was once again at the mercy of the COVID-19 pandemic as it forecasted an extended if not indefinite wait for both criminal and civil proceedings over alleged generic drug price fixing in the US to move to trial.

Legal Issues Generic Drugs

Teligent Announces $140m Operating Loss As Plant Woes Continue

Struggling Teligent underlined the importance of lifting the FDA Warning Letter against its key manufacturing facility in Buena, New Jersey, as its impact slammed the company’s operations last year.

Sales & Earnings Strategy

Samsung Bioepis Nudges Closer To Ranibizumab Approvals With New Data

Samsung Bioepis has been tight-lipped on the potential to win approval for its SB11 biosimilar ranibizumab product this year, though new similarity data is a further positive omen for the Korea-based biosimilar player.

Biosimilars Clinical Trials

Dr Reddy’s Accuses Amarin Of ‘Illegally’ Blocking Vascepa API Supply

Having sat on an approved Vascepa ANDA since August last year, Dr Reddy’s Laboratories has sued originator Amarin, claiming the firm has illegally cornered the market for the hard-to-manufacture active ingredient.

Generic Drugs Legal Issues
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