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Mylan Institutional

Division of Mylan NV
www.mylan.com

Latest From Mylan Institutional

The Quality Lowdown: Diversion, Cross-Contamination And PR Mix-Ups

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.

Quality Manufacturing

Aquinox, Astellas Mull Options As Rosiptor Fails

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.

Commercial Business Strategies

Bladder Pain, Interstitial Cystitis And The Move Toward Patient-Focused Drug Development

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.

Advisory Committees Clinical Trials

For Generics and Brand Firms, Complaints Drove Recalls in 2015

Customer complaints and internal quality systems activities drove brand/generic recalls last year while FDA was away inspecting compounding pharmacies.

BioPharmaceutical United States
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