Mylan/Aurobindo Invalidates Two Tradjenta Patents; PRV-031 (Teplizumab) Ph3 PROTECT Trial Paused

According to new court documents (view here) released yesterday, two Boehringer patents on Tradjenta were ruled invalid by the U.S. Court of Appeals for the Federal Circuit upon reviewing the appeal by Mylan and Aurobindo. Additionally, Provention Bio announced a temporary pause in the patient randomization of the Ph3 PROTECT trial for PRV-031 (teplizumab) in patients with newly diagnosed T1DM amid the COVID-19 crisis (press release). Of note, the company is on track to complete its rolling BLA submission for teplizumab treatment of at-risk patients for T1DM in Q4 ’20. Below are the key highlights and insights from these new items.

About The Author

Matthew Maryniak

President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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