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GlaxoSmithKline failed yesterday to convince an FDA advisory committee that it should be allowed to add study data showing a reduction in mortality to the label of its chronic obstructive pulmonary disease (COPD) drug Trelegy Ellipta. Read More
GlaxoSmithKline and Vir Biotechnology have dosed the first patient in a phase 2/3 clinical trial of their investigational COVID-19 antibody treatment VIR-7831 for early treatment in patients at high risk of hospitalization. Read More
Johnson & Johnson (J&J) says it will begin a phase 2 trial of its COVID-19 vaccine candidate in Spain, Germany and the Netherlands this week. Read More
J&J previously announced that it expects to begin a phase 3 trial of its vaccine candidate, Ad26.COV2.S, in 60,000 participants in early September. Read More
President Trump vowed during his acceptance speech at the Republican National Convention that a coronavirus vaccine will be ready by the end of the year even as many experts continue to express skepticism about such an expedited timeline. Read More
Ology Bioservices, an Alachua, Fla.-based biologics contract development and manufacturing organization (CDMO), has been granted a contract worth up to $106.3 million from the U.S. Army to help out with COVID-19 vaccine and therapeutic production. Read More
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outside the CNS should examine whether the treatment controls the cancer at all disease sites, according to an FDA draft guidance released Wednesday.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