In recent years, psychedelics have been gaining popularity when it comes to treating an array of mental health issues. With its promising medical and therapeutic benefits, psychedelic-assisted psychotherapy (PAP) is generating significant interest among policymakers, medical professionals, and the public. As it provides an alternative treatment for refractory mental health concerns, several cities in the U.S are starting to decriminalize some psychedelics.
Biosimilars and the BPCIA: Exploring Trends, Developments, and Critical Issues
TKG2021-05-06T21:15:13-04:00As the biosimilar industry continues to grow, significant legal developments and trends also continue to emerge and pose challenges to market participants. Questions currently hounding the future of the Biologics Price Competition and Innovation Act (BPCIA) litigation and regulatory pathway include the newly introduced Biologic Patent Transparency Act, the ongoing debates on the constitutionality of the Affordable Care Act (ACA), and the potential unavailability of inter partes and post-grant review proceedings for biosimilar manufacturers.