The US Food and Drug Administration approved a second vaccine on 31 May to protect older adults against infection from the respiratory syncytial virus (RSV). The vaccine, Abrysvo, was developed by Pfizer Inc and is expected to be launched before the next RSV season which typically starts in the autumn and peaks in the winter. The decision follows the agency’s authorisation on 3 May of a vaccine for the same disease from GSK Plc.
Ariceum Therapeutics GmbH announced the acquisition of UK-based Theragnostics Ltd on 1 June giving it a US Food and Drug Administration approved diagnostic and a pipeline of radiolabelled small molecule inhibitors for the treatment of aggressive cancers.
This is the second major business transaction for the German radiopharmaceutical company, which was co-founded in 2021 by venture capital and private equity investors. The first was a peptide-based research collaboration with UCB SA of Belgium, announced on 11 May.
Robert Califf, the US Food and Drug Administration Commissioner, took a strike against drug prices on 7 June saying that prices “are too high in the US” with the result that many patients, especially with cancer, are not completing their prescribed treatments because they cannot afford to do so.
The European Medicines Agency is recommending that Adakveo (crizanlizumab), a medicine for preventing vaso-occlusive crises in patients with sickle cell disease, be withdrawn from the EU market. This follows data from a post-authorisation study showing little benefit and a higher rate of adverse events. Developed by Novartis, Adakveo was given a conditional approval on 28 October 2020. Full approval was contingent on positive data from the STAND follow-up study.
Data from a Phase 3 trial of a combination vaccine candidate to prevent meningococcal disease, a bacterial infection that can cause death or permanent disability, were positive, according to the developer GSK Plc. The vaccine candidate showed non-inferiority in primary endpoints for five Neisseria meningitidis serogroups compared with Bexsero and Menveo, two marketed GSK vaccines, which together cover the same serogroups. The five Neisseria meningitidis serogroups account for nearly all invasive meningococcal disease cases in the world.
Gene editing technology has been used by an international team of researchers to create a new therapeutic that targets Escherichia coli in the guts of patients with blood cancers who are at risk of infection. A preclinical study of the new therapy was published in Nature Biotechnology on 4 May. The therapy, SNIPR001, was developed by Denmark-based SNIPR Biome ApS which is currently conducting a Phase 1 trial of the drug in the US. The drug has received a fast track designation from the Food and Drug Administration.
Preclinical data for the small molecule drug vidofludimus calcium has revealed its activity in relation to a neuroprotective transcription factor in addition to its ability to inhibit an enzyme which plays a key role in the metabolism of overactive immune cells and virus-infected cells, Immunic Inc announced on 17 May. The findings have been published in the Journal of Medicinal Chemistry.
Fenebrutinib, a small molecule drug being investigated for multiple sclerosis, was able to reduce brain lesions in people with the disease, the developer Roche announced on 17 May. The results were obtained from a Phase 2 trial of fenebrutinib, a Bruton’s tyrosine kinase inhibitor, which is being studied in adults with relapsing forms of the disease. Data from the study showed that fenebrutinib significantly reduced the total number of new gadolinium-enhancing T1 brain lesions compared with a placebo, the primary endpoint of the trial.
The Danish government has appointed the BioInnovation Institute (BII) in Copenhagen as the site for a new project to support entrepreneurs involved in quantum science research. The initiative adds a new dimension to the institute, which was created in 2017 to advance research and enterprise in the life science industry. The institute was started by the Novo Nordisk Foundation, an independent charity which owns Novo Holdings A/S, the majority shareholder of Novo Nordisk A/S. The foundation provided grant funding for the BII until 2021 when it became financially independent.
A Belgian start-up company, Dualyx NV, has raised €40 million in Series A financing to start clinical development of a new antibody therapeutic for autoimmune diseases. The antibody, DT-001, is an agonist of a receptor found on immune cells which is widely regarded as a master control switch in immune modulation. By agonising this receptor, DT-001 has been shown to activate regulatory T cells (Tregs) which keep the immune system from becoming overactive. The receptor is tumour necrosis factor receptor 2.