Division of Mylan NV
Latest From Mylan Institutional
McKesson meets with US FDA over opioid diversion warning letter, while UK MHRA takes risk-based approach to cross-contamination recalls and firm says it’s the other Guardian Pharmacy.
Astellas’ late-stage bet on Aquinox’s urology drug now looks highly unlikely to pay off following the molecule’s “definitive” failure in a Phase III trial, which is also forcing the originator to consider its business and R&D options.
Patients with the conditions experience the same symptoms, US FDA advisory committee concludes. Industry sponsors had advocated for combined trials, but panel did not agree with firms' recommendations on study duration and outcome measures.
Customer complaints and internal quality systems activities drove brand/generic recalls last year while FDA was away inspecting compounding pharmacies.
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