Health and Human Services Secretary Robert F. Kennedy Jr. announced eight new members to the CDC’s advisory committee on immunization practices on Wednesday, just two days after he removed all 17 sitting members. Kennedy announced on X that he is appointing Joseph R. Hibbeln, MD; Martin Kulldorff, MD, Ph.D.; Retsef Levi, Ph.D.; Robert W. Malone,…
Zoliflodacin wins FDA nod for treatment of gonorrhea
The FDA has approved zoliflodacin, a single-dose, spiropyrimidinetrione oral antibiotic for the treatment of uncomplicated gonorrhea in adults and pediatric patients 12 years and older, Innoviva announced on Tuesday. The oral antibiotic inhibits type II topoisomerase, a bacterial enzyme crucial to bacterial function and reproduction. What laid the groundwork for FDA’s zoliflodacin approval The FDA…
Secretary of Health removes all current members of the CDC advisory committee on immunization practices
Members of the CDC’s advisory committee on immunization practices (ACIP) received an email late Monday afternoon terminating their positions, said panel member Dr. Noel Brewer. This decision by Secretary of Health and Human Services Robert F. Kennedy Jr. may impact vaccine access, insurance coverage, and public health. Members of the ACIP typically serve four-year terms.…
FDA approved ENFLONSIA for the prevention of RSV in Infants
Merck announced yesterday that the FDA has approved ENFLONSIA (clesrovimab-cfor), a preventive monoclonal antibody, for the prevention of RSV lower respiratory tract disease in newborns and infants entering their first RSV season. ENFLONSIA is the only RSV preventative option that is administered with the same 105 mg dose regardless of the patient’s weight. It is…
Sanofi ramps up distribution of Beyfortus ahead of RSV season
Respiratory syncytial virus (RSV) already represents a blockbuster business with Sanofi reporting that Beyfortus (nirsevimab) hit global sales of €1.7 billion (roughly $1.77 billion) in its first full year on the market in 2024. Beyfortus protects infants from lung infections caused by RSV Beyfortus can help prevent a serious lung disease associated with RSV in…
First clinical study results of Dupixent for atopic dermatitis in patients with darker skin tones
Just over three-quarters, 76%, of patients receiving Sanofi and Regeneron’s Dupixent (dupilumab) achieved at least a 75% improvement in overall disease severity (EASI-75), the primary endpoint of the DISCOVER Phase 4 study. The study, presented at the Revolutionizing Atopic Dermatitis Conference in Nashville, focused on patients with moderate-to-severe atopic dermatitis with skin of color. Unmet…