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Mylan NV

www.mylan.com

Latest From Mylan NV

How Biocon Site Prevented FDA 'OAI' Finding From Derailing Biosimilars

By carrying out certain corrective and preventive actions, a Biocon facility in Bangalore, India, averted an "official action indicated" finding US FDA officials had proposed in an establishment inspection report, one that could have potentially delayed approval of two Mylan biosimilars. Key issues at the site included visible particles in sterile injectable drug products as well as various aseptic processing practices.

Manufacturing Quality

Pipeline Watch: Phase III Studies of CSL112 And RT-100 Imminent

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Pipeline Watch Approvals

India’s USV Joins Line-Up For Biosimilar Neulasta In Europe

USV has joined the list of firms seeking clearance for biosimilar pegfilgrastim in Europe. Managing director Prashant Tewari says the company is “well geared” to address potential price competition and maintains that biosimilarity of USV’s pegfilgrastim with the innovator product has been established “satisfactorily”.

Commercial Companies

Taking Sides On Mohawk IPR: Generic And High Tech Industries Vs. Law Profs

Groups weigh in on Tribe's request for Patent Trial and Appeal Board to drop inter partes review of Restasis patents; Deva Holding says pending Allergan infringement suit shows Allergan and Tribe have same interests.

Intellectual Property Legal Issues
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