Clinical research
The $3.1 million NCATS grant will help the company test SPI-1005 in two trials, both OK’d by the U.S. Food and Drug Administration (FDA) last August.
Shares of FibroGen were crashing this morning after the company unsuccessfully attempted to express confidence in the benefit/risk profile of its anemia drug, Roxadustat.
Ionis Pharmaceuticals unleashed a string of news releases about activities at the company, including a partnership with Progenity and the launch of a Phase III trial for amyotrophic lateral sclerosis.
The U.S. FDA issued a Complete Response Letter (CRL) over Acadia Pharmaceuticals’ supplemental New Drug Application (sNDA) for Nuplazid for hallucinations and delusions associated with dementia-related psychosis.
It was a busy week for clinical trial news. Here’s a look.
Days after announcing the U.S. Food and Drug Administration (FDA) has cleared the next clinical trials to launch for its lead natural killer (NK) cell therapies, NKMax America announced it has renamed itself NKGen Biotech.
Gaithersburg, Md.-based Emergent BioSolutions offered an update on its Phase III trial of SARS-CoV-2 Immune Globulin Intravenous (Human) (COVID-HIG) to treat hospitalized patients with COVID-19.
It’s something of the holy grail—run whole genome sequencing on a sample of a person’s blood and identify their risk for disease, all quickly and affordably. Oxford, England’s Genomics, founded in 2014 out of Oxford University by Sir Peter Donnelly, may be getting close.
A current Phase III trial of the Pfizer-BioNTech COVID-19 vaccine has confirmed the protection remains high for at least six months after the second dose. In a statement, Pfizer and BioNTech reported the vaccine was 91.3% effective against the disease.
The two companies announced data from a Phase III study which showed 100% efficacy and robust antibody responses in patients ages 12 -15 who received the BNT162b2 vaccine.
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