Adding to the already numerous lawsuits, the Teamsters union sued opioid manufacturers, distributors and pharmacy benefit managers in the U.S. District Court for the Northern District of Ohio over their…
CDER released a revised Manual of Policies and Procedures on expedited reviews of prior approval supplements for new drug and biologics license applications that involve chemistry, manufacturing and controls changes.…
The Senate Committee on Health, Education, Labor and Pensions unanimously advanced the Opioid Crisis Response Act (S. 2680) Tuesday but voted down an amendment to impose tough penalties on drugmakers.…
Generic drug approvals were in the spotlight during remarks by FDA Commissioner Scott Gottlieb before a Senate appropriations subcommittee on the FDA’s fiscal year 2019 budget request. Source: Drug Industry…
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The FDA released draft guidance on a “streamlined nonclinical program” for sponsors of nonclinical studies for development of pharmaceuticals for treatment of patients with debilitating or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…