We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Dose optimization for pediatric cancer drug trials shouldn’t rely on exhaustive analyses of toxicity, the FDA says, and members of an advisory subcommittee on pediatric oncology agree that children can’t wait for every question to be answered. Read More
Coherus BioSciences has resolved a key piece of its dispute with AbbVie over plans to market Yusimry (adalimumab-aqvh), a biosimilar for AbbVie’s blockbuster immunotherapy Humira, enabling it to begin selling the product July 1 at an 85 percent discount from AbbVie’s price. Read More
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 current system of opaque prices due to confidential rebates poses a barrier to a well-functioning pharmaceutical marketplace, a JAMA Network Open editorial states. 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
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