Melinta to seek approval of 2 antibiotics for use in kids, against biothreats

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Sick boy in hospital bedDrugmaker Melinta Therapeutics announced yesterday that it will receive funding from the Biomedical Advanced Research and Development Authority (BARDA) to advance two antibiotics targeting multidrug-resistant infections for use in children.

The two antibiotics, Baxdela (delafloxacin) and Vabomere (meropenem and vaborbactam) are already approved by the US Food and Drug Administration (FDA) for use in adults. Baxdela is used to treat acute bacterial skin and skin-structure infections and community-acquired bacterial pneumonia (CABP), and Vabomere is designed for gram-negative pathogens that produce beta-lactamase enzymes.

The $20.5 million base funding from BARDA will support plans to extend Baxdela's CABP indication to children aged 2 months to less than 18 years and Vabomere's use for complicated urinary tract infections to children aged 3 months to less than 18 years. Melinta will also use the funding to seek approval for using Vabomere to treat late-onset neonatal sepsis in infants aged less than 90 days and for Baxdela as a potential treatment option against biothreat pathogens in children and adults.

We are poised to make a lasting impact in healthcare.

The company will submit four supplemental New Drug Applications to the FDA for these new indications. Under the contract, Melinta could receive an additional $121.4 million from BARDA if all options are exercised.

"This contract fuels our excitement to explore expanded applications of Baxdela and Vabomere through innovative research," Melinta President and CEO Christine Ann Miller said in a company press release. "We are poised to make a lasting impact in healthcare, unlocking new avenues for patient care and addressing unmet needs." 

GAO releases recommendations aimed at future pandemics

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Healthcare worker preparing a COVID boosterThe US Government Accountability Office (GAO) released a report on key COVID-19 findings and recommendations, with the aim of helping federal agencies better prepare for future emergencies, according to a GAO press release.

The report is a continuation of the GAO's series on the accountability and effectiveness of the federal government's $4.7 trillion pandemic response since 2020.

The current report focuses on lessons learned from April 2022 through April 2023. Experts looked at five key areas, including public health preparedness, fraud, vulnerable populations, distribution of COVID funding, and the pandemic's impact on the US economy.

About 45% of [GAO recommendations] have been fully or partially addressed.

"As of April 2023, we've made 386 recommendations to 26 federal agencies and 19 suggestions to Congress to strengthen response and preparedness. About 45% of those have been fully or partially addressed," the GAO writes.

Heightened risk of fraud

Of note, the GAO said more federal stopgaps and surveillance measures for fraud must be taken into account as the US plans for the next pandemic.

"As federal agencies sought to expedite payments to individuals and businesses affected by the COVID-19 pandemic, agencies used some processes that GAO has previously reported can increase fraud risk,” the authors of the report wrote.

The Department of Labor, in particular, has yet to create an antifraud taskforce to address unemployment insurance, something the GAO recommended in December 2022.

The GAO also said the Department of Health and Human Services failed to update its procedures for Strategic National Stockpile inventory planning reviews and manage risks associated with inventory gaps, something that has also been recommended since 2022.

England's National Health Service expands novel payment model for antibiotics

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Pills and British pounds
Oleksandr Siedov / iStock

England's National Health Service (NHS) announced yesterday that it is expanding its subscription-style payment model for antibiotics.

Under a pilot program launched in June 2022, NHS England awarded subscription contracts of up to £10 million a year (US $12.9 million) for 10 years for access to cefiderocol and ceftazidime-avibactam, manufactured by Shionogi and Pfizer, respectively. The idea behind the program was to provide the companies with a fixed annual fee based on the value of the antibiotics to the NHS and patients, rather than the volumes sold, and remove any incentive to overuse the drugs while incentivizing companies to develop new antibiotics.

With the proposed expansion of the program, the annual contracts could double to £20 million (US $25.9 million), based on criteria developed by the National Institute for Health and Care Excellence, and all UK nations will have access to the antibiotics.

The development of new antibiotics is absolutely essential to help build resilience to respond rapidly to new superbugs and save lives.

"As we continue to take lessons from the COVID-19 pandemic, the development of new antibiotics is absolutely essential to help build resilience to respond rapidly to new superbugs and save lives," David Glover, NHS assistant director of medicines analysis, said in an NHS press release. "With the proposed expansion of our world-first subscription model following a successful pilot, we want to meet this challenge head on and lead the response to the global battle against antimicrobial resistance, which could undermine the ability to deliver routine hospital care and treatment for patients."

A 12-week consultation will seek input from the pharmaceutical industry, patients, healthcare providers, and academics. Proposals will prioritize products that are active against pathogens deemed by the World Health Organization to be the most urgent threats.

Southern Hemisphere flu activity rises; Central America reports hot spots

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H1N1 influenza viruses

Southern Hemisphere flu activity continues to rise in some countries, though levels have stabilized or are declining in others, the World Health Organization (WHO) said in its latest update, which covers roughly the middle 2 weeks of June.

Australia's flu detections rose over that period, with respiratory syncytial virus (RSV) activity also elevated. New Zealand's flu activity remains low, though levels are rising in some of the Pacific islands. South Africa's flu activity appears to have peaked at a high level in early June.

Flu declined in South America's temperate countries, the WHO said, and illness levels were reported as low in the region's tropical countries.

Some Central American countries reported increased flu levels, with Costa Rica reporting extraordinary levels, Honduras reporting high activity, and Nicaragua and Panama reporting moderate activity. Mexico's flu activity is higher than expected for this time of year. In tropical Asia, Bangladesh reported a slight increase.

Of respiratory samples that tested positive for flu at national labs during the reporting period, 67.4% were influenza A, and, of the subtyped samples, 74.3% were the 2009 H1N1 virus. All characterized influenza B viruses belonged to the Victoria lineage.

Quick takes: Dengue vax pulled from FDA review, mpox in Trinidad & Tobago, US West Nile cases

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  • Takeda yesterday announced that it voluntarily withdrew its Food and Drug Administration (FDA) licensing application for its dengue vaccine candidate because of issues with data collection that can't be resolved during the current review cycle. The company said it would further evaluate the plan for the vaccine, given the need to protect travelers and those living in dengue-endemic areas of the United States, such as Puerto Rico. The vaccine is already approved in several endemic and non-endemic countries. Currently, the only FDA-approved dengue vaccine is GSK's Dengvaxia, which is indicated only for children ages 6 to 16 who have evidence of previous infection and live in endemic areas.
  • Trinidad and Tobago's health minister yesterday reported the country's first mpox case, which involves a middle-aged man who has a travel history, according to a local media report. Contact tracing is under way, and health officials are planning a vaccination push. The World Health Organization in its latest update on the current global outbreak said 88,288 cases, 149 of them fatal, have been reported in 112 countries.
  • Ten states have reported 36 human West Nile virus (WNV) cases this year, the Centers for Disease Control and Prevention said in its latest update, which notes that levels of the mosquito-borne illness rise in the summer and continue into fall and can fluctuate by year. Arizona has the most cases, with 25 reported to date. So far, 23 neuroinvasive infections have been reported. In a related development, the Texas Department of State Health Services yesterday reported its first human WNV case of the year, in a resident of Dallas County who was diagnosed as having neuroinvasive disease.

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