Innoviva launches ceftobiprole in the US, shifts in FDA COVID-19 vaccine policy, a surge in fungal infections, and more.
Innoviva Specialty Therapeutics, which is a subsidiary of Innoviva, announced its antibiotic, ceftobiprole (Zevtera), is available for prescribing in the US. The antibiotic was approved in April 2024, and now marks the first cephalosporin indicated to treat SAB.1 “The availability of Zevtera in the US marks the introduction of our second novel therapy in 2 years, addressing drug-resistant pathogens that pose significant health risks, particularly in hospitals and out-patient settings,” said Innoviva CEO Pavel Raifeld, said in a statement.
In a Salmonella outbreak associated with whole cucumbers, there have been 26 reported cases including 9 hospitalizations across 15 states. There have been no deaths reported.1 According to the CDC, businesses should not sell or serve whole cucumbers grown by Bedner Growers and distributed by Fresh Start Produce between April 29, 2025 to May 19 2025. 1 Several people ate cucumbers on cruise ships. These cucumbers were distributed to stores, restaurants, and other facilities. CDC points out these cucumbers may be within shelf life for the rest of this week. Cucumbers may have been sold individually or in smaller packages and the types could be labeled as "supers," "selects," or "plains." These cucumbers are not organic varieties.1
Moderna announced today it has voluntarily withdrawn the pending BLA for its influenza/COVID-19 combination vaccine candidate, mRNA-1083. The late-stage vaccine was indicated for adults aged 50 years and older.1 This withdrawal comes after the FDA had requested that Moderna provide more data for its vaccine. Specifically, the federal agency requested more phase 3 influenza efficacy data.2 The FDA request came earlier this month, and based on the agency’s feedback, Moderna expected an extended review timeline.2 The company plans to resubmit the BLA later this year, after vaccine efficacy data from the ongoing phase 3 trial of its investigational seasonal influenza vaccine, mRNA-1010, are available. Moderna continues to expect interim data from the mRNA-1010 trial to be available this summer.1 The company is now targeting FDA approval in 2026.
In the first quarter of 2025, California reported 3,123 cases of Valley Fever (Coccidioidomycosis), nearly double the 10-year average for this period. This is the highest number reported for Q1 on record, surpassing the previous record of 3,011 cases in 2024. Following a record-breaking year in 2024 with 12,637 cases statewide, experts warn California may be on track to exceed last year’s total. Updated reports are still being anticipated. 1 Monterey County, CA, has seen a particularly sharp increase. In the first quarter of 2023, only 22 cases were reported. By the same period in 2025, the number had surged to 217. This increase is part of a larger trend of rising cases across the state, with some areas of the Central Valley seeing a 200% increase in cases over the past year.1
In an article published this week in the New England Journal of Medicine, FDA Commissioner Marty Makary, MD, MPH, and Vinay Prasad, MD, MPH, director of the FDA's Center for Biologics Evaluation and Research (CBER), laid out their plan that will change the bar for how COVID-19 vaccines will be approved going forward. They are seeing this through 3 groups: adults 65 years of age and older, those between the ages of 6 months and 64 years, and high-risk groups. They are taking a differing approach for each of them.