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A New York jury has found Teva Pharmaceuticals guilty of fueling the state’s opioid crisis through misleading marketing about the risks of its highly addictive painkillers. Read More
A federal court has ordered New Jersey-based Natural Solutions Foundation (NSF) to stop selling a “nano silver” solution marketed to prevent and treat coronavirus infections, and to recall and destroy all product distributed this year. Read More
Jeffrey Zients, White House COVID-19 response coordinator, acknowledged in a press briefing that deliveries will be slow to start, especially for Pfizer’s Paxlovid. Read More
Over the past year, President Biden touted that the nearly $2 trillion Build Back Better Act would bolster the nation’s social safety net, fight climate change and introduce drug pricing reform. Read More
Though the FDA last week authorized the first COVID-19 oral antivirals for at-home use — Pfizer’s Paxlovid and Merck’s and Ridgeback Biotherapeutics’ molnupiravir — access to the pills will be limited in the new year. Read More
A group of 852 hospitals has sent Department of Health and Human Services (HHS) Secretary Xavier Becerra a letter pressing HHS to appeal a federal court ruling that drugmakers have the ability to restrict sales of medicine that’s handled by contract pharmacies as part of the 340B drug discount program. Read More
Bluebird Bio pledged to work with the FDA to resolve the hold and said it expects to receive written questions from the agency on the program early next year. Read More
The FDA has placed a partial clinical hold on Bluebird Bio’s gene therapy for sickle cell disease (SCD), lovotibeglogene autotemcel (lovo-cel), for trial participants under the age of 18 after a volunteer contracted persistent anemia. Read More
AbbVie is pushing the International Trade Commission (ITC) to prevent Iceland-based biosimilar developer Alvotech from marketing its biosimilar candidate to AbbVie's blockbuster Humira (adalimumab). Read More