Biogen Inc.’s pricing of its newly approved Alzheimer’s drug, Aduhelm (aducanumab), has made it the latest bull’s eye for lawmakers and advocacy groups targeting U.S. drug prices, especially given the controversy surrounding the drug’s approval, which has resulted in the resignation of three of the 11 members of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee.
The good of the many versus the good of the individual is the age-old question that faced the FDA’s Vaccines and Related Products Advisory Committee (VRPAC) June 10 as it considered the risk-benefit issues of COVID-19 vaccines in children. Panelist Cody Meissner, director of pediatric infectious disease at Tufts Medical Center, said while he believes a vaccine is needed for children, he wants to know that the safety of the vaccine is greater than the risk of hospitalization for people younger than 18.
Heralded as a potential turning point for U.S. innovation in the 21st century, the U.S. Innovation and Competition Act, S. 1260, is a big step closer to becoming law. The Senate voted 68-32 June 8 to pass the sweeping $250 billion bipartisan bill intended to give the U.S. an edge over China when it comes to innovation and investment in several critical industries, including artificial intelligence, biotechnology and quantum computing.
Recognizing that people with cancer want to know what symptoms they may experience and how a particular therapy may affect their quality of life, the FDA is issuing a draft guidance advising sponsors on incorporating a core set of patient-reported outcomes (PROs) into cancer clinical trials.
In a bid to bring more drug manufacturing back to the U.S. and to ensure an adequate supply of essential medicines, even in public health emergencies, the U.S. Department of Health and Human Services is forming a public-private consortium on advanced manufacturing and the onshoring of domestic production.
The European Commission unveiled its third alternative to providing global access to COVID-19 vaccines and treatments just ahead of the June 8 meeting of the World Trade Organization’s Council for Trade Related Aspects of Intellectual Property Rights and the start of the G7 summit.
Preparing for the full implementation of the 2013 Drug Supply Chain Security Act (DSCSA), the FDA finalized two guidances June 3 and released two draft guidances to help supply chain partners comply with the law’s requirements, including those for enhanced drug distribution security at the package level that go into effect in November 2023.
The U.S. Federal Trade Commission (FTC) is turning the biopharma industry’s claim about rebates on its ear, saying some rebates paid to pharmacy benefit managers and third-party payers are an anticompetitive tool drug companies use to maintain their U.S. market power.
Two weeks ago, it was a grilling by the House Oversight Committee over the pricing of blockbuster drugs Humira and Imbruvica and a request for the FTC to launch an investigation into Abbvie Inc.’s patent settlements that delayed Humira biosimilar competition in the U.S. until 2023. This week, Abbvie became the face of a new investigation by the Senate Finance Committee over how multinational companies are shifting profits overseas as a way to avoid U.S. taxes.