On October 22, 2024, Novo Nordisk made a submission to the U.S. Food and Drug Administration (FDA) nominating Novo Nordisk’s semaglutide products (WEGOVY, OZEMPIC and RYBELUS) to be included in the FDA’s lists of drug...more
On August 19, 2024, the Association for Molecular Pathology (AMP) sued the FDA to challenge a new rule that allows the FDA to regulate laboratory developed tests (LDTs). The rule, which became effective on July 5, 2024,...more
The Federal Trade Commission (FTC) issued a policy statement on September 14, 2023, stating that “[b]rand drug manufacturers may be harming generic competition through the improper listing of patents in the Food and Drug...more
12/5/2023
/ Competition ,
Federal Trade Commission (FTC) ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
FTC Act ,
Generic Drugs ,
Hatch-Waxman ,
Healthcare ,
Life Sciences ,
Orange Book ,
Patents ,
Pharmaceutical Patents ,
Prescription Drugs ,
Section 5
On March 29, 2023, the Solicitor General of the United States asked the Supreme Court to review a Federal Circuit judgment in a Hatch-Waxman case between Teva and GSK. In its decision below, the Federal Circuit held that Teva...more
Research supporting the role of the microbiome in human, animal, and plant health continues to grow at a staggering rate. While the wave of new health technologies emerging from this research rises, companies working in the...more