Pfizer Inc.’s Ticovac has been approved by the FDA for immunizing those ages 1 year and older against tick-borne encephalitis, a disease that’s not endemic to the U.S. but increasingly is found in Europe and Asia. Ticovac, developed with a master seed virus, was first approved outside the U.S. 45 years ago. Before the FDA approval, the CDC had recommended that travelers on their way to high-risk areas be vaccinated in Europe though the process could take up to six months.
Finding a functional cure to HIV is one of the biggest challenges in modern medicine, a task made so much tougher because of the virus’s ability to incorporate itself permanently into a host’s genome. But Diaccurate SAB, of Paris, thinks it may have a solution – and it’s all down to a discovery showing that the virus seems to make crucial immune CD4 cells go “bumpy”, lose their function and die.
Positive phase III top-line results for Valneva SA’s chikungunya virus vaccine candidate, VLA-1553, show the study met its primary endpoint of inducing neutralizing antibody titers, setting it up for possible accelerated approval.
Shares of Iterum Therapeutics plc fell 40% July 26 after disclosing that the FDA issued a complete response letter (CRL) for its NDA for sulopenem etzadroxil/probenecid (oral sulopenem), an anti-infective compound, for urinary tract infections (UTIs). The agency determined the NDA cannot be approved in its present form.
China’s NMPA gave conditional approval to Henan Sincere Biotech Co. Ltd.’s dual-targeting, oral HIV drug, azvudine, to treat HIV-1-infected adult patients with high viral loads. Azvudine could challenge lamivudine, a drug extensively used for treating HIV infection.
Proceeds from Vedanta Biosciences Inc.’s just closed $68 million series D financing will be used for a phase III study of the company’s lead candidate, VE-303, composed of eight clonal human commensal bacterial strains to give colonization resistance for treating Clostridioides difficile (C. diff) infection, and also for a phase II study of VE-202, made up of 16 clonal human commensal bacterial strains for treating inflammatory bowel disease.
The complete relegation of conferences to cyberspace that began with one HIV conference, CROI 2020, ended with another, the 2021 IAS meeting. Though the conference was still largely virtual, there was also an in-person component held in Berlin.
DUBLIN – Poolbeg Pharma plc raised £25 million (US$35 million) in an IPO on London’s Alternative Investment Market (AIM) to pursue development of antiviral drugs. The company priced the offering at 10 pence per share, which implies a valuation of £50 million. Shares are due to commence trading on Monday, July 19.
Aicuris Anti-Infective Cures AG is beginning the pivotal phase III part of its trial of pritelivir for herpes simplex virus infection after an encouraging midstage readout.
The World Health Organization (WHO) and the Global Fund to Fight AIDS, Tuberculosis and Malaria signed a cooperation and financing agreement to implement 10 initiatives in 2021 through 2023 aimed at addressing persistent challenges impeding global progress against the three diseases and protecting hard-won gains from new pandemics like COVID-19.
RSS
