Ironwood Pharmaceuticals’ Linzess (linaclotide) is the first drug to receive FDA approval to treat functional constipation in children age six to 17 years with a recommended daily dosage of 72…
A dozen states have signed on to Illumina’s appeal of the Federal Trade Commission’s (FTC) order that the company divest itself of Grail — developer of the Galleri early cancer…
This monthly feature consists of excerpts from articles printed in GMP Newsletter LOGFILE, reprinted by permission of the publisher, GMP-Verlag Peither AG. Source: Drug Industry Daily
The discounts drug manufacturers are forced to offer pharmacy benefit managers (PBM) and insurance companies on their products are driving the sharp rise in drug prices, according to a study…
The FDA’s Office of Prescription Drug Promotion (OPDP) issued a seven-page untitled letter informing Xeris Pharmaceuticals that its website advertising the drug Recorlev (levoketoconazole) makes “false or misleading claims and…
The National Association of Manufacturers (NAM) and the Washington Legal Foundation (WLF) have entered the “right to repair” legal fray, questioning the Library of Congress’s (LOC) ability to grant copyright…
Pfizer has become the latest pharma company to unveil serious drug shortages in the ongoing U.S. drug supply crisis, announcing the discontinuation of two penicillin products and the limited supply…
Upcoming events in the coming weeks include five FDA advisory committee meetings as well as webinars on subjects ranging from GxP system verification and FDA’s sterilization pilot. Source: Drug Industry…
Specialized scientific liaisons will be key to moving rare disease drugs through the Accelerating Rare Disease Cures (ARC) Program, according to CDER Director Patrizia Cavazzoni. Source: Drug Industry Daily
An FDA final guidance on premarket submissions for device software functions recommends a risk-based approach to help determine whether the sponsor should submit basic or enhanced documentation to explain its…