Healthcare & Pharmaceutics

DOJ and Mallinckrodt Pharmaceuticals Reach $35 Million Settlement Related to Opioid Epidemic

Repurposing and Enforcement during Patent Term Extensions for Pharma Products

Can a U.S. compound patent be enforced during its patent term extension against a new use of an old drug otherwise covered by the patent?

Health

Aiming for Transparency: Clinical Trial Disclosures in the United States and European Union

Darshan Kulkarni, Synchrogenix, Philadelphia, PA, Ashley Thomas, Baker Donelson, Washington, DC and Andrea Tunnard, MS Candidate 2019, University of the Sciences, Philadelphia, PA

The disappointing results of a new tuberculosis vaccine booster in clinical studies have raised questions about the transparency of data used to make regulatory and patient decisions.

Health

The Opioid Epidemic and the Future of Public Health Emergencies

Sarah A. Wetter, James G. Hodge, Jr, Danielle Chronister and Alexandra Hess, Center for Public Health Law and Policy, Sandra Day O’Connor College of Law, Arizona State University, Phoenix, AZ

On October 26, 2017, after weeks of internal deliberations, President Donald Trump directed Acting Secretary of Health and Human Services (HHS) Eric Hargan to declare a national state of public health emergency (PHE) in response to the escalating opioid epidemic. In so doing, the President classified the opioid epidemic as the deadliest PHE to ever be so designated since the nomenclature originated in 2001.