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New cephalosporin antibiotic for Staph aureus bacteremia available in US
News brief
7 minutes ago.
Chris Dall, MA
Topics
Antimicrobial Stewardship
MRSA
US drugmaker Innoviva Specialty Therapeutics announced today that the novel cephalosporin antibiotic Zevtera (ceftobiprole medocaril sodium for injection) is now commercially available in the United States.
Zevtera is an advanced-generation cephalosporin with effectiveness against gram-positive and gram-negative bacteria. It was approved by the US Food and Drug Administration (FDA) in April 2024 for three indications: (1) methicillin-resistant and methicillin-susceptible Staphylococcus aureus bacteremia (SAB), including right-sided infective endocarditis, in adults; (2) acute bacterial skin and skin-structure infection in adults; (3) and community-acquired bacterial pneumonia in adults and children as young as 3 months.
The approval was granted to Swiss biopharmaceutical company Basilea Pharmaceutica, which sold the rights to market the drug in the United States to Innoviva in December 2024.
New option for potentially deadly infections
Company officials say Zevtera offers physicians a new option for treating challenging and potentially deadly infections. Approximately 100,000 cases of SAB occur every year in the United States, with nearly 20,000 deaths. The 90-day mortality rate is roughly 30%.
"Zevtera is an excellent addition to our antibiotics portfolio and its market availability further underscores our strategic commitment to deliver meaningful innovations in infectious diseases," Innoviva Chief Medical Officer David Altarac, MD, said in a company press release.
Moderna pulls licensing submission for combo flu-COVID vaccine
News brief
Today at 2:31 p.m.
Stephanie Soucheray, MA
Topics
COVID-19
Today vaccine maker Moderna announced it voluntarily pulled its licensing submission for the combination seasonal influenza–COVID-19 mRNA vaccine candidate, mRNA-1083, so that it can submit efficacy data.
The news comes a day after the US Food and Drug Administration announced that seasonal COVID-19 boosters would now be recommended only for adults ages 65 and older or for those who are at risk for severe COVID-19 because of underlying health conditions.
Moderna's combination vaccine was intended for adults 50 and older.
Moderna continues to expect interim data from the mRNA-1010 trial to be available this summer.
"Moderna continues to expect interim data from the mRNA-1010 trial to be available this summer," the company said in a press release. The resubmission will take place after gathering vaccine efficacy data from the ongoing phase 3 trial of its investigational seasonal flu vaccine, mRNA-1010.
After hospitalization for pneumonia, COVID-19 patients report lasting symptoms
News brief
Today at 2:28 p.m.
Stephanie Soucheray, MA
Topics
COVID-19
A multicenter study published yesterday in Emerging Infectious Diseases shows significant long-term symptoms among adults hospitalized for pneumonia during acute COVID-19 infection a full year after hospitalization.
The study observed patient from the United States, Kenya, and Peru who were enrolled in one of five clinical trials tracking outcomes from severe COVID-19 infections. At the time of enrollment in the parent studies, the authors said, 158 participants (91.3%) were not on mechanical ventilation, whereas 15 (8.7%) required mechanical ventilation or extracorporeal membrane oxygenation. The average patient age was 56, and 52.6% of participants had lung abnormality imaging at baseline.
Almost half had lasting fatigue
Of 134 patients who completed follow-up through 12 months, 29.5% reported cough, 34.7% reported shortness of breath, 32.4% had residual lung texture abnormalities on computed tomography (CT) scans, 15.0% had impaired lung capacity, 30.1% had cognitive impairment, and 44.5% noted lasting fatigue. Cardiac function remained unchanged from baseline for most participants.
Cognitive impairment and fatigue were closely related to underlying health condition seen at baseline, most notably high blood pressure, the authors said.
Our findings underscore the extended health effects of COVID-19 beyond its acute phase and reinforce the importance of regular monitoring of patients with severe COVID-19.
"The high prevalence of lung abnormalities at baseline, measured at a median of 155 days after participants completed the parent study, aligns with postacute COVID-19 syndrome and meets the definition for long COVID," the authors wrote. "The severity of acute infection, age, and certain underlying conditions might influence the long-term sequelae of COVID-19. Our findings underscore the extended health effects of COVID-19 beyond its acute phase and reinforce the importance of regular monitoring of patients with severe COVID-19, particularly in older patients and those with underlying health conditions."
ALL BRIEFS
New cephalosporin antibiotic for Staph aureus bacteremia available in US
News brief
7 minutes ago.
Chris Dall, MA
Topics
Antimicrobial Stewardship
MRSA
US drugmaker Innoviva Specialty Therapeutics announced today that the novel cephalosporin antibiotic Zevtera (ceftobiprole medocaril sodium for injection) is now commercially available in the United States.
Zevtera is an advanced-generation cephalosporin with effectiveness against gram-positive and gram-negative bacteria. It was approved by the US Food and Drug Administration (FDA) in April 2024 for three indications: (1) methicillin-resistant and methicillin-susceptible Staphylococcus aureus bacteremia (SAB), including right-sided infective endocarditis, in adults; (2) acute bacterial skin and skin-structure infection in adults; (3) and community-acquired bacterial pneumonia in adults and children as young as 3 months.
The approval was granted to Swiss biopharmaceutical company Basilea Pharmaceutica, which sold the rights to market the drug in the United States to Innoviva in December 2024.
New option for potentially deadly infections
Company officials say Zevtera offers physicians a new option for treating challenging and potentially deadly infections. Approximately 100,000 cases of SAB occur every year in the United States, with nearly 20,000 deaths. The 90-day mortality rate is roughly 30%.
"Zevtera is an excellent addition to our antibiotics portfolio and its market availability further underscores our strategic commitment to deliver meaningful innovations in infectious diseases," Innoviva Chief Medical Officer David Altarac, MD, said in a company press release.
Moderna pulls licensing submission for combo flu-COVID vaccine
News brief
Today at 2:31 p.m.
Stephanie Soucheray, MA
Topics
COVID-19
Today vaccine maker Moderna announced it voluntarily pulled its licensing submission for the combination seasonal influenza–COVID-19 mRNA vaccine candidate, mRNA-1083, so that it can submit efficacy data.
The news comes a day after the US Food and Drug Administration announced that seasonal COVID-19 boosters would now be recommended only for adults ages 65 and older or for those who are at risk for severe COVID-19 because of underlying health conditions.
Moderna's combination vaccine was intended for adults 50 and older.
Moderna continues to expect interim data from the mRNA-1010 trial to be available this summer.
"Moderna continues to expect interim data from the mRNA-1010 trial to be available this summer," the company said in a press release. The resubmission will take place after gathering vaccine efficacy data from the ongoing phase 3 trial of its investigational seasonal flu vaccine, mRNA-1010.
After hospitalization for pneumonia, COVID-19 patients report lasting symptoms
News brief
Today at 2:28 p.m.
Stephanie Soucheray, MA
Topics
COVID-19
A multicenter study published yesterday in Emerging Infectious Diseases shows significant long-term symptoms among adults hospitalized for pneumonia during acute COVID-19 infection a full year after hospitalization.
The study observed patient from the United States, Kenya, and Peru who were enrolled in one of five clinical trials tracking outcomes from severe COVID-19 infections. At the time of enrollment in the parent studies, the authors said, 158 participants (91.3%) were not on mechanical ventilation, whereas 15 (8.7%) required mechanical ventilation or extracorporeal membrane oxygenation. The average patient age was 56, and 52.6% of participants had lung abnormality imaging at baseline.
Almost half had lasting fatigue
Of 134 patients who completed follow-up through 12 months, 29.5% reported cough, 34.7% reported shortness of breath, 32.4% had residual lung texture abnormalities on computed tomography (CT) scans, 15.0% had impaired lung capacity, 30.1% had cognitive impairment, and 44.5% noted lasting fatigue. Cardiac function remained unchanged from baseline for most participants.
Cognitive impairment and fatigue were closely related to underlying health condition seen at baseline, most notably high blood pressure, the authors said.
Our findings underscore the extended health effects of COVID-19 beyond its acute phase and reinforce the importance of regular monitoring of patients with severe COVID-19.
"The high prevalence of lung abnormalities at baseline, measured at a median of 155 days after participants completed the parent study, aligns with postacute COVID-19 syndrome and meets the definition for long COVID," the authors wrote. "The severity of acute infection, age, and certain underlying conditions might influence the long-term sequelae of COVID-19. Our findings underscore the extended health effects of COVID-19 beyond its acute phase and reinforce the importance of regular monitoring of patients with severe COVID-19, particularly in older patients and those with underlying health conditions."
ALL BRIEFS