A combination therapy – Gilead Science’s Biktarvy – a hybrid medicine and a generic can look forward to EU approval after getting the OK from the EMA’s drug evaluation committee last week.
Gilead Sciences Inc.’s new fixed-dose combination therapy for HIV, Biktarvy, was recommended for approval throughout the EU last week.
Join thousands of industry professionals who rely on Pink Sheet for daily insights
Already a subscriber?
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include four new products, one of which is Tivdak, Pfizer/Genmab’s treatment for previously treated recurrent or metastatic cervical cancer.
Eisai is working on securing reimbursement across the EU for Leqembi now that the Alzheimer’s disease treatment has secured marketing approval from the European Commission.
The African Medicines Agency is to appoint a director general and become operational at the end of this month.
Antabio’s next-generation, broad-spectrum antibacterial, MEM-ANT3310, has made it onto the European Medicines Agency’s priority medicines scheme. The company says its product is designed to make a significant impact on the growing problem of antimicrobial resistance.
Tracy Beth Høeg, who is reportedly re-examining Novavax’s COVID vaccine application, is the FDA rep at the CDC panel’s first meeting under the Trump Administration. She raised concerns about routine use of Jynneos for adolescents at risk of mpox and questioned how Moderna assessed efficacy of its COVID vaccines.
The African Medicines Agency is to appoint a director general and become operational at the end of this month.
Antabio’s next-generation, broad-spectrum antibacterial, MEM-ANT3310, has made it onto the European Medicines Agency’s priority medicines scheme. The company says its product is designed to make a significant impact on the growing problem of antimicrobial resistance.
