Colchicine, an ancient treatment for gout, has been approved by the US Food and Drug Administration (FDA) for treating vascular inflammation present in patients with heart disease. The therapy, now produced by Agepha Pharma, is combined with a statin and reduces risk of serious cardiovascular events […]
BMS Joins the Legal Fray Over Medicare Drug Pricing Negotiations
Bristol Myers Squibb (BMS) has thrown its legal hat in the ring, filing a lawsuit against the Biden Administration over upcoming Medicare drug pricing negotiations set up by the Inflation Reduction Act. In doing so, they join Merck as legal challengers to the process, which will set the prices drug […]
Dr. Mandy Cohen Selected for Next CDC Director
Mandy Cohen, MD, has been selected by the Biden Administration to lead the Centers for Disease Control and Prevention (CDC) as its next director. Cohen, who lead North Carolina’s response to COVID-19, will take the helm in early July, according to the White House. She is succeeding the current […]
Drug Prices from Major Brand Names Dropped ~50% Last Year
According to new data released by the Drug Channels Institute, brand-name drug prices from 10 key manufacturers dropped by half last year after discounts and rebates were accounted for. The manufacturers include Eli Lilly, Johnson & Johnson, Novo Nordisk. Much of the savings, however, have gone […]
US Chamber of Commerce Files Suit Over Upcoming Drug Pricing Negotiations
The second volley of legal challenges over upcoming Medicare drug pricing negotiations has been fired, this time by the US Chamber of Commerce. The chamber argues that the negotiations, brought on by the Inflation Reduction Act, would violate pharmaceutical companies’ due process rights by enforcing […]
List of Medications Facing Inflation-Linked Rebates Increases
The Centers for Medicare and Medicaid Services (CMS) has expanded the list of drugs that will be subject to rebates tied to price increases that exceed the current rate of inflation. The number, which was previously 20, now stands at 43, and includes drugs for leukemia, lymphoma, and asthma from […]
FDA Advisory Committee Votes in Favor of Eisai, Biogen’s Leqembi
An advisory committee for the US Food and Drug Administration (FDA) voted 6-0 in favor of full approval for Leqembi, Eisai and Biogen’s treatment for Alzheimer's disease. The decision was made based on results from the Clarity AD study, which the committee members believed strongly supported its […]
FDA Brief Supports Full Approval for Alzheimer’s Drug Leqembi
In a newly released brief, the US Food and Drug Administration (FDA) vocalized support for the full approval of Eisai and Biogen’s Alzheimer's drug Leqembi. The brief, which comes before an FDA adcomm this Friday, June 9th, shows that the agency considers the drug’s efficacy well-supported by […]
The Odds Don’t Favor Merck’s Drug Price Negotiation Lawsuit
Merck filed suit against the Centers for Medicare and Medicaid Services (CMS) recently, marking the first pharmaceutical company to do so. However, according to Stephen L. Carter of Bloomberg, the lawsuit may be dead in the water. The reason, he argues, is the basis of the suit, which hinges on the […]
GSK’s RSV Vaccine Nabs First EU Approval of its Kind
Glaxo-Smith Klein (GSK) has received approval by the European Commission for its respiratory syncytial virus (RSV) vaccine Arexvy in adults aged 60 and up. This marks the first EU approval of a vaccine for RSV vaccine. This puts them ahead of Pfizer, whose vaccine Abrysvo has yet to be approved in […]
