ASC40 meaningfully reduces liver fat in Phase II NASH trial
ASC40 reduced liver fat and significantly lowered an enzyme associated with liver inflammation in nonalcoholic steatohepatitis (NASH) patients.
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NICE approves gene therapy for spinal muscular atrophy
Zolgensma, a one-off, potentially curative treatment for type 1 spinal muscular atrophy, is set to become the most expensive drug ever approved for use on the UK’s NHS.
COVID-19 T cell test submitted for emergency use authorisation
In clinical testing, the T-SPOT.COVID test was found to agree with PCR test results in over 96 percent of samples taken within first 60 days of infection.
India’s Covaxin® 81 percent effective against COVID-19
An interim analysis reveals the Covaxin® (BBV152) vaccine was relatively safe and 81 percent effective in preventing symptomatic COVID-19.
Urine test developed to diagnose subclinical kidney transplant rejection
The novel, non-invasive test detects a rejection signature within mRNA isolated from urine and could, with further development, be used instead of biopsies to identify transplant rejection.
QUZYTTIR™ shows promise in preventing infusion related reactions
Phase II data suggests intravenous QUZYTTIR™ cetirizine hydrochloride can decrease infusion reactions to anti-CD20 antibody treatments and reduce time to discharge after therapy.
EMA concludes review of Lilly’s COVID-19 antibody therapies
The human medicines committee decided that there was significant evidence to endorse the use of a combination of bamlanivimab and etesevimab in outpatients at high risk of severe COVID-19.
Ivermectin not beneficial to symptom resolution in mild COVID-19 patients
In a trial of over 400 adult patients with mild COVID-19, ivermectin did not significantly improve the time to symptom resolution compared to placebo.
Novel biobattery-powered microneedle patch enables delivery of large molecule drugs
The novel microneedle array uses electroosmotic flow and a series of interconnected micropores to deliver large molecules or extract of fluid samples.
EMA and Health Canada to make COVID-19 vaccine data open access
Starting with the publication of clinical data used to support the authorisations of the Moderna COVID-19 vaccine, EMA and Health Canada said they will continue the open access approach for all COVID-19 vaccines.
US closes enrolment in two COVID-19 antibody studies due to futility
The sub-studies evaluating VIR-7831 and BRII-196 with BRII-198 have stopped enrolment based on recommendations from the Data and Safety Monitoring Board.
Experimental immunotherapy significantly delays onset of type 1 diabetes
If approved for use, teplizumab could be the first drug able to delay the onset or completely prevent type 1 diabetes in at-risk groups.
EMA begins rolling review of Sputnik V COVID-19 vaccine
The EU regulator has begun reviewing preclinical and early trial data for Sputnik V, the COVID-19 vaccine developed by Russia.
New partnership to explore potential biodefence applications for FX-06
Under a licensing and collaboration agreement, Partner Therapeutics will evaluate whether FX-06 could be used to treat multiple biothreats of interest to the US Government.
NIH halts COVID-19 convalescent plasma trial
The trial evaluating COVID-19 convalescent plasma as a treatment for COVID-19 patients with mild to moderate symptoms was stopped due to ineffectiveness.
