2024 was a critical year for the FDA’s Center for Devices and Radiological Health and included a smooth transition in leadership, but it was not without controversy. The agency triggered not one but two lawsuits over the final rule for regulation of lab-developed tests, a problem that promises to distract the agency throughout 2025 and potentially beyond.
With antimicrobial resistance growing to many first-line antibiotics, a key concern in the U.S. FDA’s approving an oral penem like Iterum Therapeutics International Ltd.’s tablet combining sulopenem etzadroxil and probenecid is that it could become a first-line, go-to drug in treating uncomplicated urinary tract infections and, possibly, more serious infections off-label.
The U.S. FDA warning letter to AG Essence Inc., a maker of wound care products, raised the question of whether the the company’s Banda product line is a drug or a device, although the FDA’s device center was the issuer of the warning letter. However, the company told ioWorld that it sees its offerings as homeopathic products rather than as drugs or devices, suggesting that this product jurisdiction scrum is far from over.
A different class of antibiotics could ease the increasing resistance triggered by some gram-negative bacteria. LpxC inhibitors are not new, but all attempts to develop them have failed due to cardiovascular toxicity or ineffectiveness. A modification of the structure of these compounds may have solved the problem. Duke University scientists demonstrated the preclinical safety and efficacy of an LpxC inhibitor candidate against a wide selection of these pathogens.
COVID-19 is the unwanted gift that keeps on giving. The U.S. CDC unwrapped one of those “presents” in a July 12 report that showed the threat of antimicrobial-resistant (AMR) infections has worsened — with resistant hospital-onset infections and deaths in the U.S. each increasing at least 15% during the first year of the pandemic.
Biomérieux SA is stepping up investments in the antimicrobial resistance (AMR) space through a new new €40 million ($40.75 million) joint venture with Evotec SE and Boehringer Ingelheim GmbH. The companies are teaming up to launch a new company, Aurobac Therapeutics SAS which will develop AMR diagnostic tests and antimicrobial therapies.
Facing the global threat of antimicrobial resistance (AMR), the EMA issued a final revised guideline on the evaluation of new antibiotics. In accordance with an agreement with the U.S. FDA and Japan’s Pharmaceuticals and Medical Devices Agency, the EMA’s guideline aligns as much as possible with the data requirements of those regulators so drug developers can design clinical trials that meet the evidence needs of all three agencies, the EMA said.
Facing the global threat of antimicrobial resistance (AMR), the EMA issued a final revised guideline on the evaluation of new antibiotics. In accordance with an agreement with the U.S. FDA and Japan’s Pharmaceuticals and Medical Devices Agency, the EMA’s guideline aligns as much as possible with the data requirements of those regulators so drug developers can design clinical trials that meet the evidence needs of all three agencies, the EMA said.
It’s been seven years since economist Jim O’Neill began his review on antimicrobial resistance, commissioned by the U.K. government to find ways to encourage development of badly needed new antibiotics. Since then, the pandemic has produced radical changes in society and forced pharma to refocus its R&D priorities at short notice. But COVID-19 has also raised awareness about the devastating effect that rogue pathogens can pose to society, and there are now serious moves to prevent a global catastrophe caused by antibiotic resistant bacteria.
An international whole genome sequencing study has shown that diphtheria, an easily preventable but highly contagious potentially fatal upper respiratory tract infection by Corynebacterium diphtheriae, is evolving antimicrobial resistance, which could lead to the loss of protection that has evolved with changes in the diphtheria toxin.
