Mylan Encounters "Irrational Pricing" In Duragesic Generics Market
Pricing pressure for fentanyl transdermal resulted from "premarketing" by other ANDA filers and regulatory uncertainty that gave "authorized" generic marketer Sandoz an advantage, Mylan CEO says. Timing of other generic entrants and potential supply problems for J&J/Sandoz could allow Mylan to recover lost profits.
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The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.
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