Income-based Advance Premium Tax Credits (APTCs) were established through the Affordable Care Act (ACA) to make health insurance more affordable for qualifying Americans purchasing coverage through the Marketplaces. However,...more
On Wednesday, Oct. 29, the Food and Drug Administration (FDA) issued draft guidance proposing to update its biosimilar review framework. Under the new approach, most biosimilar applications will no longer require comparative...more
The Senate Judiciary Committee’s Intellectual Property Subcommittee convened a pivotal hearing to examine the Patent Eligibility Restoration Act of 2025 (PERA), a bipartisan legislative proposal aimed at resolving...more
10/17/2025
/ Artificial Intelligence ,
Biotechnology ,
Intellectual Property Protection ,
Life Sciences ,
New Legislation ,
Patent Litigation ,
Patent-Eligible Subject Matter ,
Patents ,
Popular ,
Section 101 ,
USPTO
On Oct. 9, the Senate, by a voice vote, adopted an amendment to the National Defense Authorization Act (NDAA) from Sens. Bill Hagerty (R-TN) and Gary Peters (D-MI), which adds an updated version of the BIOSECURE Act to the...more
The Senate Judiciary Committee’s Intellectual Property Subcommittee held a critical hearing on the Patent Eligibility Restoration Act of 2025 (PERA), a bipartisan bill that seeks to restore clarity to Section 101 of the...more
The Food and Drug Administration (FDA) has said it intends to provide new “Commissioner’s National Priority Vouchers” (CNPV) to certain drug applicants that will be able to claim a one- to two-month drug review—much shorter...more
On Thursday, Sept. 25, President Donald Trump announced new tariffs of 100% on pharmaceutical products imported into the United States starting Oct. 1, but said there would be exceptions made for companies investing in U.S....more
9/29/2025
/ Imports ,
International Trade ,
Medical Devices ,
National Security ,
Pharmaceutical Industry ,
Popular ,
Section 232 ,
Tariffs ,
Trump Administration ,
U.S. Commerce Department ,
US Trade Policies
On Sept. 25, President Donald Trump announced new tariffs on heavy trucks, pharmaceuticals and select furniture and cabinetry, effective Oct. 1, 2025, pending formal issuance in the Federal Register. As of this writing,...more
9/29/2025
/ Bureau of Industry and Security (BIS) ,
Imports ,
International Trade ,
National Security ,
Popular ,
Section 232 ,
Tariffs ,
Trade Expansion Act of 1962 ,
Trump Administration ,
U.S. Commerce Department ,
US Trade Policies