Aicuris Anti-Infective Cures AG is preparing to file for U.S. FDA approval after reporting positive phase III results for lead antiviral pritelivir in the healing of refractory herpes simplex virus lesions in immunocompromised patients.

One in six common bacterial infections diagnosed worldwide in 2023 were resistant to treatment with antibiotics, according to the latest surveillance data gathered by the World Health Organization (WHO). Drug-resistant gram-negative bacteria that cause bloodstream infections that can lead to sepsis, organ failure and death are an increasing threat globally.

An uncommon route to the public markets – direct listing – paid off for Turn Therapeutics Inc., with shares (NASDAQ:TTRX) closing Oct. 9 at $9.20, up $2.20, or 31%, having risen as high as $26.50 in its second day of trading. The firm is advancing late-stage clinical programs in eczema and onychomycosis. Also in the works are global health initiatives in thermostable vaccine delivery designed to serve underserved areas.

Even though the U.S. CDC is operating on a skeleton crew due to the partial government shutdown, it is updating its immunization schedules to adopt the COVID-19 and chickenpox vaccine recommendations the Advisory Committee on Immunization Practices (ACIP) made at its September meeting.

While the discussions and votes at the past two meetings of the U.S. CDC Advisory Committee for Immunization Practices (ACIP) have generated a lot of controversy and resulted in some states and medical groups issuing their own vaccine schedules, the truth is that the newly reconstituted committee’s recommendations to date are still in line with, or more generous in some instances than, global norms.

Enanta Pharmaceuticals Inc.’s phase IIb study of zelicapavir missed its primary endpoint in treating respiratory syncytial virus (RSV) but mined enough positive results to get the company to talk about advancing the once-daily oral treatment into further, larger studies.

Globally, over half of people living with HIV are women. But in clinical cure trials, they make up only about 20% of participants. And that gender imbalance is causing researchers to miss out on ways to improve cure strategies. Because women’s immune systems appear to be better at controlling HIV infection in a way that silences the reservoir – the provirus integrated into host cells in infected persons.

Breaking with its long-held, oft-recited mantra that observational studies are great for generating hypotheses but not as evidence for approval, the U.S. FDA is initiating the approval of leucovorin calcium tablets for patients with cerebral folate deficiency, a neurological condition that affects folate transfer into the brain.

The second day’s meeting of the U.S. CDC’s Advisory Committee for Immunization Practices (ACIP) took up guidelines related to COVID-19 vaccines, of which an outspoken skeptic is Health and Human Services Secretary Robert Kennedy – who in June fired all 17 members of ACIP and replaced them with names more to his liking.