Reckitt Benckiser (RB Group) has agreed to pay $700 million to settle multiple lawsuits filed by states in federal courts over marketing practices for its addiction treatment drug Suboxone (buprenorphine).…
Drugmakers increased the list prices of their drugs far beyond the inflation rate between 2017 and the first quarter of 2019, California found in a first-of-its kind study of 1,020…
Congress has given the go-ahead for a restructuring aimed at improving CDER’s new drug reviews. Source: Drug Industry Daily
Two FDA advisory committees voted 16-8 on Thursday against recommending pediatric labeling for Endo Pharma’s Opana IR (immediate-release oxymorphone). Source: Drug Industry Daily
The FDA cited an OTC drugmaker in California for violations at its facility involving its manufacturing equipment and quality system. Source: Drug Industry Daily
The FDA issued a warning letter to a Chinese drugmaker for significant cGMP violations related to identity testing, process validation and its written stability program. Source: Drug Industry Daily
A federal judge in Florida has thrown out 149 lawsuits in multidistrict litigation alleging Abilify (aripiprazole) caused their compulsive behavior. Source: Drug Industry Daily
Acting FDA Commissioner Ned Sharpless flagged “significant quality and sterility concerns” surrounding a Melbourne, Florida outsourcing facility on Tuesday, as the agency sought a recall of all sterile products compounded…
The FDA issued a warning letter to OTC drug manufacturer Ningbo Pulisi Daily Chemical Products in Zhejiang, China for testing violations, including failure to fully test products prior to release.…
A federal court in Delaware has denied Baxalta’s request for a new trial in a suit brought by Bayer over patent infringement by Baxalta’s hemophilia A drug Adynovate. Source: Drug…