In responding to an FTC/HHS request for information (RFI) on how drug wholesalers and group purchasing organizations (GPOs) influence generic drug shortages, the trade group for generic and biosimilar drug manufacturers has requested an investigation of the drug buyers’ practices. Read More

How can regulators judge the efficacy and safety of a product that makes patients feel so good, so quickly, that trial blinding is impossible, and the drug’s positive effects may carry abuse potential? Read More

Novo Nordisk has sued nine more companies for selling products billed as containing semaglutide, a primary ingredient in the Danish pharma’s popular weight loss drug Wegovy. Read More

This month’s feature consists of excerpts from articles printed in GMP Newsletter LOGFILE, reprinted by permission of the publisher, GMP-Verlag Peither AG. Read More

A February data breach at drug distributor Cencora has exposed the personal medical information of tens of thousands of patients, according to filings with numerous state attorneys general (AG) and the Securities and Exchange Commission (SEC). Read More

The FDA approved Amgen’s Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to AstraZeneca’s Soliris (eculizumab) to treat the rare diseases paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). Read More

The final version of an International Council of Harmonisation (ICH) guideline that addresses evaluation of the drug-drug interaction (DDI) potential of an investigational drug is ready for adoption and a draft of a guideline on general principles for planning pharmacoepidemiological studies is ready for review. Read More

An FDA advisory committee voted 7-4 that the risk of serious hypoglycemia seen with Novo Nordisk’s Awiqli insulin outweighed the convenience of its once-a-week dosing regimen for people with type 1 diabetes. Read More