Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Podcast: Non-binding Guidance: FDA Regulatory and Patent Implications of the Transition Provision of the Biologics Price Competition and Innovation Act
Drug Pricing Initiatives During the Trump Presidency
A changing competitive landscape: the role of the ITC in the biosimilars space
Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute
In May 2025, the FDA approved numerous biosimilars as interchangeable with Stelara® (ustekinumab) and Humira® (adalimumab), bringing the total number of Stelara® interchangeables to four, plus an additional biosimilar (Sandoz...more
On 19 February 2019 the U.S. Food and Drug Administration (FDA or the agency) released a draft guidance entitled, "Nonbinding Feedback After Certain FDA Inspections of Device Establishments" (draft guidance) for comment. ...more
On July 18, FDA Commissioner Scott Gottlieb, M.D., announced the release of FDA’s Biosimilars Action Plan (BAP), saying it would help enable a path to competition for biologics from biosimilars, while preserving incentives...more
On December 19, 2017, FDA approved the gene therapy Luxturna (voretigene neparvovec-rzyl), developed by Spark Therapeutics, to treat children and adults with biallelic REP65 mutation-associated retinal dystrophy, an inherited...more
The U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the European Commission – DG Sante (DG Sante), signed a new confidentiality commitment which expands the scope of the current...more
President Donald J. Trump has now been in office for just over one hundred days. Observers have been quick to mark this milestone and assess the new administration’s performance, especially on headline-grabbing issues like...more