MHRA joins international regulatory consortium
By joining the Access Consortium, the MHRA will work together with agencies from Australia, Canada, Singapore and Switzerland to expedite therapeutic product approvals.
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By joining the Access Consortium, the MHRA will work together with agencies from Australia, Canada, Singapore and Switzerland to expedite therapeutic product approvals.
The adaptive ACTIV-5/BET study will test two monoclonal antibody therapies in hospitalised COVID-19 patients to establish if they warrant larger clinical trials.
The US Food and Drug Administration (FDA) has approved Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn) for the treatment of Zaire ebolavirus infection in adults and children.
The US government will develop and manufacture AstraZeneca’s investigational monoclonal antibody cocktail, AZD7442, a potential prophylactic treatment for COVID-19.
The European Commission (EC) has signed a joint procurement contract to ensure an uninterrupted supply of Veklury (remdesivir) for participating countries.
The ITAC trial will establish if adding hyperimmune intravenous immunoglobulin (hIVIG) to a remdesivir regimen can improve hospitalised COVID-19 patient outcomes.
NoveCite has an exclusive licence to develop and commercialise mesenchymal stem cell therapies to treat acute respiratory conditions such as Acute Respiratory Distress Syndrome (ARDS).
Dolutegravir plus lamivudine was as effective at suppressing HIV-1 in adult trial participants as a three-drug regimen, dolutegravir plus tenofovir disoproxil fumarate/emtricitabine (TDF/FTC).
Neflamapimod taken three times a day significantly improved cognition in trial participants with mild-to-moderate dementia with Lewy bodies (DLB).
A clinical trial has demonstrated that the likelihood of hospitalisation was significantly reduced for patients with mild COVID-19 when given fluvoxamine.
Researchers have developed a novel tablet formulation of ibandronate which increases the oral bioavailability of the drug by releasing it from a hydrogel raft formed in the stomach.
Treatment with Zolgensma® (onasemnogene abeparvovec) resulted in rapid and sustained improvement in motor function in spinal muscular atrophy (SMA) patients.
Interim trial results suggest vamorolone may offer a superior alternative to long-term treatment with high-dose glucocorticoids in young Duchenne muscular dystrophy (DMD) patients.
Researchers suggest, based on certain exclusions, older people are likely to be underrepresented in 50 percent of COVID-19 trials and all vaccine trials in the US.
An Emergency Use Authorization (EUA) request for the use of RLF-100™ (aviptadil) in critical COVID-19 patients was submitted to the US FDA.