Combination Antibiotic For Multidrug-Resistance Closer To Approval; Newborns Need Less Antibiotics

CIDRAP: Combination Antibiotic Gets Boost From European Regulators 
Pfizer announced last week that its novel investigational combination antibiotic for multidrug-resistant bacterial infections has moved a step closer to regulatory approval in Europe. (Dall, 3/26)

CIDRAP: Study Highlights Potential To Reduce Antibiotic Use In Newborns
A large nationwide study in Sweden found that low exposure to antibiotics in newborns treated in neonatal units over a 9-year period was not associated with an increased risk of early-onset sepsis (EOS), researchers reported today in JAMA Network Open. (Dall, 3/22)

CIDRAP: FDA OKs Invivyd's COVID Preventive Pemgarda For Emergency Use 
The Food and Drug Administration (FDA) on March 22 granted emergency use authorization (EUA) for Invivyd's monoclonal antibody to prevent COVID-19 in immunocompromised patients, which fills a gap following the withdrawal of Evusheld in January 2023. (Schnirring, 3/25)

CIDRAP: New Data Show Paxlovid Outperforms Molnupiravir Against Severe COVID-19 Outcomes 
A large study yesterday in the International Journal of Infectious Diseases shows that, if prescribed within 5 days of confirmed infection, Paxlovid (nirmatrelvir-ritonavir) is more effective in protecting against all-cause mortality and severe COVID-19 in adults than is molnupiravir, another antiviral drug. (Soucheray, 3/22)

New England Journal of Medicine: Risk Of Autism After Prenatal Topiramate, Valproate, Or Lamotrigine Exposure 
Maternal use of valproate during pregnancy has been associated with an increased risk of neurodevelopmental disorders in children. Although most studies of other antiseizure medications have not shown increased risks of these disorders, there are limited and conflicting data regarding the risk of autism spectrum disorder associated with maternal topiramate use. (Hernandez-Diaz, M.D., Dr.P.H., et al, 3/21)