Interim results from the phase 1/2 COV001 trial evaluating the vaccine candidate ChAdOx1 nCoV-19 (AZD1222) showed that vaccination led to strong immune responses against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in all evaluated participants.
Participants demonstrated high levels of neutralizing antibody activity that exceeded those seen in convalescent sera obtained from persons with confirmed COVID-19.
A phase 3 trial evaluating sarilumab (Sanofi and Regeneron), an interleukin-6 antagonist, in patients with COVID-19 requiring mechanical ventilation did not meet its primary and key secondary end points.
Pfizer and BioNTech SE announced positive preliminary results from the phase 1/2 study evaluating the safety, tolerability, and immunogenicity of escalating doses of the vaccine candidate BNT162b1 against COVID-19.
The FDA has granted Breakthrough Therapy designation to AXS-05 (Axsome Therapeutics) for the treatment of Alzheimer disease (AD) agitation.
A phase 1 study evaluating the safety, reactogenicity and immunogenicity of SCB-2019, a vaccine candidate for coronavirus disease 2019 (COVID-19), has been initiated by Clover Biopharmaceuticals.
The FDA has approved Semglee™ (insulin glargine injection; Mylan and Biocon) to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.
The FDA has cleared EndeavorRxTM (AKL-T01; Akili Interactive) for use as a prescription-only video game-based digital therapeutic to improve attention function in pediatric patients aged 8-12 years with primarily inattentive or combined-type ADHD.