Friday’s European Commission approval is a boost to AbbVie as the company looks to lean on its immunology assets, including Skyrizi, to soften the blow of Humira’s loss of exclusivity.
In an FDA MedWatch update, the agency has issued an alert to HCPs, compounders, and patients about dosing errors that can occur as a result of patients measuring and self-administering incorrect doses of injectable semaglutide products. FDA has received reports of adverse events, including some that have required hospitalization.
As organizations focus on finding the most efficient pathways to market and provide patients with rapid access to novel treatments, they face a variety of regulatory hurdles. These challenges are influenced not only by regional regulatory developments but also by a company’s global footprint, the size and capabilities of regulatory teams, resource limitations and the target markets for commercialization.
The deal strengthens Boehringer Ingelheim’s oncology pipeline of cancer cell-directed and immuno-oncology investigational therapies for smart combinations in an effort to improve health outcomes for people living with cancer.
The test, known as Shield, has been available in the U.S. as a laboratory-developed test since 2022.
Pfizer’s, GSK’s, and Moderna’s competition for arms for their new respiratory syncytial virus (RSV) vaccines is on Wall Street’s watch list for when the companies report earnings later this week.