Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute
We closed out July 2025 in Boston alongside several of our Axinn colleagues attending the American Conference Institute’s 12th Annual Summit for Women Leaders in Life Sciences Law. This conference is a highlight for us every...more
ACI’s FDA Boot Camp is back in Boston! This essential training course – now in its 41st iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under...more
For over 15 years, ACI’s FDA Boot Camp has been the training grounds for life sciences attorneys and executives to master the fundamentals of FDA regulation. The approval process…pre-approval concerns…product...more
This month we highlight two Federal Circuit obviousness-type double patenting decisions. CASES - Federal Circuit - Section 156 Patent Term Extension and Obviousness-Type Double Patenting - Novartis AG v. Ezra...more
Obtain the guidance you need to master the difficult area of FDA regulatory law - For over 15 years, ACI’s FDA Boot Camp has been the training grounds for life sciences attorneys and executives to master the fundamentals of...more
This month we highlight two reversals by the Federal Circuit and a summary judgment of indefiniteness from New Jersey. CASES - Federal Circuit - Grant of Preliminary Injunction Reversed - Indivior Inc. v. Dr....more
This month we highlight a district court opinion from Judge Dyk, sitting by designation, denying a preliminary injunction in a brand-vs-brand litigation, and a lengthy district court opinion from Judge Bryson, sitting by...more
This month, we highlight significant developments in June 2018, including a Supreme Court decision regarding the PTAB, a federal court affirmation in Impax Laboratories Inc. v. Lannett Holdings Inc., and new legislation...more
As is the tradition here at Health Law & Policy Matters, towards the end of the year we take stock of what transpired in our respective industries and highlight important legal, regulatory, and business developments. For...more
This post, Part III, of a three-part series on FDA’s interchangeability draft guidance highlights a number of open issues that stakeholders have identified in their comments to FDA....more
The comment period for FDA’s draft guidance Considerations in Demonstrating Interchangeability With a Reference Product closed on Friday, May 19, 2017. Innovators, biosimilar makers, patients, healthcare providers and other...more