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Two clinical trials of Mersana Therapeutics’ ovarian cancer drug UpRi (upifitamab rilsodotin) are on a partial clinical hold from the FDA because of five deaths linked to serious bleeding. Read More
The industry association representing pharmacy benefit managers (PBM) has fired back at the introduction of a Senate bill that would curtail their revenue based on the price of the drugs they manage, pointing the finger instead at drug companies that set high prices. Read More
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 mcg orally. Read More
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 screening test — arguing that the commission’s process in the case was unconstitutional. Read More
This monthly feature consists of excerpts from articles printed in GMP Newsletter LOGFILE, reprinted by permission of the publisher, GMP-Verlag Peither AG. Read More
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 published Wednesday in JAMA Network Open. Read More
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 representations about the safety and efficacy” of the tablets. Read More
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 exemptions to third-party repair companies without the opportunity for judicial review. Read More
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 of several penicillin syringes. Read More