Industry watchers were surprised when Eli Lilly and Co.’s oral GLP-1 candidate, orforglipron, did not appear among the first nine recipients of the U.S. FDA’s commissioner’s national priority voucher (CNPV) program aimed at shortening regulatory review times, boosting domestic manufacturing and improving affordability. But orforglipron, which recently nailed endpoints in a second phase III trial and has been hailed a potentially best-in-class compound, was among the second batch of six drugs added to the CNPV list.
Adaptor protein-2 associated kinase 1 (AAK1) is key in clathrin-mediated endocytosis, which diverse viruses hijack in order to infect cells. Inhibiting AAK1 has been shown to block the entry of hepatitis C, dengue and rabies viruses into cells.
Oxford Nanopore Technologies plc and Biomérieux SA launched Ampore-TB, a research use only test that can rapidly detect mutations linked to antimicrobial resistance in tuberculosis. With multidrug-resistant TB affecting an estimated 400,000 people annually and increasing risks of morbidity and mortality, this assay could help with earlier diagnosis of drug resistance in patients.
Current treatments for herpes simplex virus 1 (HSV-1) mainly target the viral DNA polymerase, but resistance is becoming an increasing problem. By understanding how HSV-1 initiates replication, scientists hope to find new ways to intervene before this stage, which could potentially contribute to avoid resistance.
Roche Holdings AG received CE mark approval for its Elecsys Dengue Ag test, a fully automated, high-throughput immunoassay to help diagnose acute dengue virus infections. With cases of dengue on the rise worldwide, the test, which delivers results in 18 minutes, offers high sensitivity and specificity across all four dengue virus serotypes, and will help clinicians confidently distinguish dengue from other illnesses causing acute fever.
Ena Respiratory Pty Ltd. raised an AU$34 million (US$22.4 million) series B round to advance INNA-051, its nasal spray for symptomatic viral respiratory infections, to phase II trials. New investors in the Melbourne-headquartered company include the Gates Foundation and Flu Lab. Existing investors Brandon Capital, Uniseed and Stoic Venture Capital also participated in the round.
Microbiotix Co. Ltd. has obtained IND approval from the Korean Ministry of Food and Drug Safety (MFDS) for MP-101, a bacteriophage therapy for patients with acute pneumonia. A phase I study in adult patients with Pseudomonas aeruginosa-induced pneumonia is expected to enroll its first patient within the year.
Scientists at Technical Institute of Physics and Chemistry, Chinese Academy of Sciences have disclosed hypocrellin derivatives acting as photosensitizers for photodynamic therapy reported to be useful for the treatment of cancer, bacterial infections and fungal infections.
Hamlet Biopharma AB has announced the presentation of new preclinical-stage molecules that have originated from its long-term collaboration with Lund University and Linnane Pharma AB with the aim of treating bacterial infections by targeting the disease response of the host rather than the pathogen itself.
SVF Vaccines AB, a portfolio company of Karolinska Development AB, has presented positive results from a preclinical study of its immunotherapy SVF-001 targeting chronic hepatitis B (HBV) and D viruses (HDV).
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