Phase III
Eli Lilly and Company and Incyte announced today that their Phase III COV-BARRIER study of Olumiant (baricitinib) plus standard of care (SoC) compared to placebo plus SoC failed to hit statistical significance against COVID-19 for its primary endpoint.
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.
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.
AbbVie won the NDA on the strength of definitive results in a Phase III ADVANCE trial, where atogepant met all six secondary endpoints at the 30-60 mg dose range, proving statistically significant in heading off migraines in nearly 2500 adult participants who experience them between 4-14 days per month.
PRESS RELEASES