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Trials of drugs to treat cancer in the central nervous system (CNS) that has metastasized from solid tumors outside the CNS should examine whether the treatment controls the cancer at all disease sites, according to an FDA draft guidance released Wednesday. Read More
VBI received a $42 million contract from the Canadian government earlier this month to support its COVID-19 vaccine development program through phase 2 testing. Read More
Partner Therapeutics has enrolled the first patient in a phase 2 trial evaluating its inhaled Leukine (sargramostim) for hospitalized COVID-19 patients. Read More
Moderna’s coronavirus vaccine candidate was well-tolerated and worked well in elderly COVID-19 patients in a small, early-stage trial, the company said Wednesday, following promising results announced in July for younger patients. Read More
The National Institutes of Health (NIH) said it plans to study an investigational antiviral from Gilead Sciences that proponents believe may offer significant advantages over remdesivir as a possible COVID-19 treatment. Read More
AstraZeneca has dosed the first participants in a phase 1 trial of its investigational monoclonal antibody product AZD7442 for preventing and treating COVID-19. Read More
FDA Commissioner Stephen Hahn issued an apology Tuesday for the way he portrayed the effectiveness of convalescent plasma as a COVID-19 treatment during the announcement of the FDA’s Emergency Use Authorization (EUA) — but he stressed the independence of the agency in its regulatory decisions amidst concerns of political pressure. Read More
The World Health Organization (WHO) has expressed doubts about the FDA’s decision to grant an Emergency Use Authorization (EUA) for convalescent plasma as a COVID-19 treatment, claiming that the supporting evidence is weak. Read More