Health Law Diagnosed Podcast—2022 Resolutions

On December 22, 2021, FDA took another step in rolling back enforcement policies implemented in response to the COVID-19 pandemic by publishing guidance documents describing the regulatory requirements for devices that were authorized under the emergency use authorization process and those under temporary FDA policies implementing specific enforcement discretion during the pandemic once the Public Health Emergency for COVID-19 ends. The Transition Plan Guidances will help device manufacturers prepare for the end of the PHE and continue to commercialize devices necessary for the long-term response to COVID-19.

The deal will take public ProKidney, a leading clinical-stage cellular therapeutics company focused on chronic kidney disease, and is expected to provide up to $825 million in gross cash proceeds.

Mintz and Licensing & Collaborations Practice Member John Cheney have represented BeiGene in numerous licensing transactions, including strategic collaborations with Amgen, Mirati Therapeutics, and Celgene, among others.

Mintz advised acute health care services and specialty hospital company Kindred Healthcare and private equity firm TPG Capital in the sale of Kindred Healthcare to LifePoint Health, a national hospital and health care services provider. The combined company, ScionHealth, operates 79 hospital campuses in 25 states.

In our 2021 pro bono journal, Transcending, we share the stories of clients who have made life-changing transitions against seemingly insurmountable odds.