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Latest From Mylan NV
US FDA extends its own user fee deadline; biosimilars earn a dubious milestone; and EMA unveils some contingency planning for Brexit. Policy Prescriptions rounds up recent regulatory news and trends reported by sister publication the Pink Sheet
Policy that would allow generic sponsors to change product labels has been delayed yet again, not spiked completely, even with Commissioner Gottlieb's known opposition to the rule.
Plan would empower new agency to investigate and potentially fine drug manufacturers that make unjustified price increases.
With Theravance Biopharma's promising once-daily nebulized LAMA bronchodilator, partnered with Mylan, set for FDA filing later this year, analysts say the product might have a bigger market than initially presumed, and are now looking beyond to the firm's other pipeline activities.
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Eric Sprague, VP, Fin.
Sarvar Kothavala, VP, Mktg.
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