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Mylan NV

www.mylan.com

Latest From Mylan NV

Will Inter Partes Review Go Away? Supreme Court Weighs Fate

Biopharma and generic industries stand on opposing sides in case that could eliminate the patent challenge proceeding. Interactive timeline covers IPR's five-year history leading to oral arguments Nov. 27.

Legal Issues Intellectual Property

Keeping Track: A Second Straight Burst Of FDA Approvals

The latest drug approval and development news from our US FDA Performance Tracker.

Performance Tracker Drug Review

Apotex's Neulasta, Neupogen Biosimilars Clear Legal Hurdles, But Approval Questions Remain

Federal appeals court affirms ruling that Apotex's biosimilars do not infringe Amgen's manufacturing process patent, but its applications have stalled at FDA for the past three years.

BioPharmaceutical Policy

EpiPen 'Failures': More Bad Headlines For Mylan – And Reminder Of FDA's Own Risks

Latest headlines about EpiPen cite deaths associated with product 'failures.' The attention is probably unfair, given the source (US FDA adverse event reports) but it is also inevitable given the history – and may be a warning of headlines to come if and when a generic is approved.

Inflammation Generic Drugs
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