Investigational antibody-drug conjugate enfortumab vedotin, developed by Seattle Genetics and Astellas, has received priority review status from the FDA as a treatment for a specific group of patients with metastatic or locally advanced urothelial cancer. Data from a midstage trial served as the basis for the designation.
Bacteria are evolving antimicrobial resistance faster than humans are developing new antibiotics, and researchers say animals are a crucial bridge between the Petri dish and human testing of new treatments, including a vaccine candidate for salmonellosis being developed by researchers led by Sophie Helaine. Bacteria respond differently in culture than in a living being, and it's important to test vaccines and antibiotics against a real-world infection, Helaine says.
Switching off the gene for methyltransferase SETD3 prevented viral replication in cells and completely protected mice and human lung cells from enteroviruses, and the mice with the gene switched off lived normal, healthy lives, researchers reported in Nature Microbiology. The researchers say the work is a step toward developing a drug that temporarily suppresses the protein to protect against rhinoviruses that cause the common cold as well as other enteroviruses that cause paralysis.
Inovio Pharmaceuticals is the recipient of a $4.6M grant from the NIH that it will use to advance research on antimicrobial resistance with the use of its DNA-encoded monoclonal antibodies scaffold. The funding will support preclinical studies to be launched as clinical trials to assess dMAbs for infections resistant to antimicrobials.
The FDA has cleared Siemens Healthineers' Artis Icono angiography system for use in various minimally invasive surgeries in a single interventional suite. The system is expected to enhance 2D and 3D abdominal imaging and neuroradiology in neurointerventions and interventional radiology.
The FDA has approved an investigational device exemption for Avita Medical's 65-patient pivotal study of its Recell autologous cell harvesting system for soft tissue reconstruction. The study will compare conventional skin grafting with and without using the device.
Abbott's Amplatzer Piccolo occluder and Masters HP mechanical heart valve both received CE mark approvals from European regulators. Masters HP is indicated for implantation in the mitral or aortic position to mimic a healthy heart valve and the occluder is designed to close the opening in the heart in patent ductus arteriosus.
Merck's application seeking the FDA's approval for its V920 Ebola vaccine has been accepted by the agency, with the PDUFA date set for March 14, 2020. Merck has already submitted an application for the Ebola vaccine in Europe earlier this year and is also seeking prequalification status from the World Health Organization.
Osmotica Pharmaceuticals, a subsidiary of Vertical Pharmaceuticals, has submitted a marketing application with the FDA for RVL-1201, indicated as a treatment for the condition called blepharoptosis, or droopy eyelid. The ophthalmic formulation is administered once a day and is designed to target the Muller's muscle, which raises the upper eyelid.
A small British study evaluated data from 11 patients with polycythemia vera and essential thrombocythemia using the rheumatoid arthritis drug methotrexate and found that the drug improved their disease symptoms and also lowered raised blood counts, according to the British Journal of Haematology. "Given the very low cost of MTX, this research could offer an effective therapy on a budget accessible to healthcare systems throughout the world -- marking a potentially substantial clinical and health economic benefit," said study co-author Dr. Martin Zeidler of the UK's University of Sheffield.
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