This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for June 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including guidance regarding hospital...more
Three organizations serving primarily HIV and AIDS patients and who each are also considered “Covered Entities” under the 340B Drug Pricing Program (the Plaintiffs) filed a lawsuit against Department of Health and Human...more
We are pleased to provide you with the third annual installment of our Life Sciences and Health Care Horizons guide. For each of these guides, we have asked our industry thought leaders throughout the world to write about...more
Must every silver lining come with a drenching cloud? Medicine has made major advances in treating fearsome conditions like cancer, HIV-AIDS, congenital heart disorders, and infectious diseases. This progress has won deserved...more
Manufacturers who want to introduce generic drugs face a special delay and enjoy a corresponding special right to challenge patents on branded drugs based on the great compromise in the Hatch-Waxman Act. ...more
The X. Civil Senate of the German Federal Court of Justice has granted a motion by three companies of the Merck Sharp & Dohme group (Merck) for a preliminary permission for the continued distribution of Isentress®, a drug...more
Current law permits a hospital, health system, or medical school to organize and become a member of a medical foundation, which can practice medicine through its employees or agents who are physicians, chiropractors,...more
On August 28, 2015, the Health Resources and Services Administration (“HRSA”) published proposed Omnibus Guidance (the “Proposed Guidance”) governing policies related to section 340B of the Public Health Service Act (“PHSA”),...more