Actavis’ Pulmicort Respules Generics Race Out The Door Before “Short Injunction”
The company is barred from further distributing its budesonide inhalation suspension until April 12; the generic launched April 1 following a patent victory over AstraZeneca, but a New Jersey federal judge said a “limited temporary injunction” was warranted to give the innovator time to seek appellate relief.
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One day after declaring one Pulmicort patent invalid and another not infringed, a New Jersey federal judge granted AstraZeneca’s bid to temporarily block Actavis and other ANDA filers from launching and distributing their budesonide generics.
AstraZeneca investors will have to wait two more months to hear details of CEO Pascal Soriot’s plans for re-energizing the struggling big pharma. But the new chief did discuss several near-term objectives for the company and what he has pinpointed as being some of the operational problems, based on discussion with hundreds of employees, during a year-end financial call Jan. 31.
Agency recommendation for randomized controlled trials in ultra-rare pediatric disease is unworkable for various reasons, say advocates and sponsors who seek use of the accelerated approval pathway based on changes in heparan sulfate levels.