We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA sent Pfizer a complete response letter for its proposed biosimilar of Genentech’s Herceptin (trastuzumab), saying it needs to see more data before approving the breast cancer drug. Read More
The FDA’s Center for Biologics Evaluation and Research published guidance on information to include in biologics license application datasets, including data on clinical trial endpoints and adverse events. Read More
An FDA advisory committee was split on Monday over several questions on Eli Lilly’s rheumatoid arthritis dosage, voting in favor of efficacy for both a 2 mg and 4 mg dosage but voting against the safety and risk-benefit profile of the larger dosage. Read More
The FDA released draft guidance on a “streamlined nonclinical program” for sponsors of nonclinical studies for development of pharmaceuticals for treatment of patients with debilitating or life-threatening hematologic disorders, saying such nonclinical studies should consider general toxicology, pharmacology and reproductive toxicology. Read More
FDA Commissioner Scott Gottlieb said the agency will continue to take action against compounders who produce drugs under substandard conditions. Read More
Generics spending dropped $5.5 billion in the United States in 2017 due largely to competition and price decreases, according to the IQVIA Institute for Human Data Science report, Medicine Use and Spending in the U.S. A Review of 2017 and an Outlook to 2022. Read More