Glucagon-like peptide-1 agonists, a class of medications known as GLP-1s, have grown in popularity, initially for the treatment of type 2 diabetes and more recently for obesity and other labeled and off-label indications for...more
3/25/2025
/ Deadlines ,
Drug Compounding ,
Enforcement Actions ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Healthcare ,
Intellectual Property Protection ,
Manufacturers ,
Pharmaceutical Industry ,
Pharmacies ,
Popular ,
Prescription Drugs ,
Regulatory Requirements ,
Supply Shortages ,
Trademarks
In 2021, the Federal Circuit determined that Amgen’s biotech antibody patents lack enablement, i.e., the specification did not teach one of ordinary skill in the art how to make and use the invention without undue...more
The U.S. Supreme Court’s recent unanimous decision clears the way for state regulation of Pharmacy Benefit Managers (“PBMs”). Rutledge v. Pharm. Care Mgmt. Ass’n, 141 S. Ct. 474 (2020). At issue before the High Court was...more
2/3/2021
/ Drug Pricing ,
Employee Retirement Income Security Act (ERISA) ,
Health Insurance ,
Pharmaceutical Industry ,
Pharmacies ,
Pharmacy Benefit Manager (PBM) ,
Popular ,
Preemption ,
Prescription Drug Coverage ,
Prescription Drugs ,
Rutledge v Pharmaceutical Care Management Association ,
SCOTUS
In a recent decision, the Federal Circuit affirmed Delaware District Court’s finding of invalidity based on failure to define the scope of the invention and to meet the written description requirements of 35 USC § 112. IBSA...more