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. Source:…

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. Source: Drug…

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…

The FDA released draft guidance on a “streamlined nonclinical program” for sponsors of nonclinical studies for development of pharmaceuticals for treatment of patients with debilitating or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…

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…

In a reversal, the National Institutes of Health said the Helping to End Addiction Long-term Initiative (HEAL) — the trans-agency effort to combat the opioid crisis launched early this month…

FDA Commissioner Scott Gottlieb said pharmacy benefit managers may be “complacent participants” in schemes to stifle biosimilar competition and raise drug prices by keeping cheaper versions of drugs off the…

Clinical trials for depot buprenorphine products for opioid dependence treatment should not focus on standard endpoints, but also consider novel efficacy endpoints not directly focused on opioid use, according to…

The federal government issued a notice of proposed rulemaking that would postpone its revisions to the Common Rule on the use of human subjects in clinical trials for another six…

Sixteen Democratic and independent senators wrote to HHS Secretary Alex Azar urging him to negotiate lower prices for the opioid overdose reversal drug naloxone. Source: Drug Industry Daily