Lilly's monoclonal antibody therapy, bamlanivimab (LY-CoV555), has received emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for the treatment of adults and children with recently diagnosed, mild to moderate COVID-19.
Agenus Inc, an immuno-oncology company with a pipeline of agents designed to activate immune response to cancers and infectious diseases, has reported the dosing of the first COVID-19 patient with agenT-797, an allogeneic cell therapy, through its subsidiary,...
To support COVID-19 global preparedness, Stirling Ultracold is engaging directly with several pharmaceutical companies currently involved in COVID-19 vaccine development, with the idea of building a fleet of ULT freezers capable of storing their approved...
A lot of new companies have been entering the diagnostics field this year to address the challenges of the COVID-19 pandemic. Cytiva, as a diagnostic component provider, has been investing in new and existing sites and services to support that surge in...
Thermo Fisher Scientific is seeing “very, very significant demand” for its cold storage range as the race to get COVID-19 vaccines to market enters its closing stages.
A new mathematical modeling study by Ashish Goyal and colleagues, informed by data collected from 25 patients hospitalized with COVID-19 in four different countries, offers some important new insights into the optimal timing of four different antiviral...
Moderna has flagged the diversity of the US-based Phase 3 trial of its COVID-19 vaccine candidate, mRNA-1273, for which enrollment, now at 30,000, has completed.
The National Institute for Biological Standards and Control (NIBSC) in the UK, and Q2 Solutions in the US, have joined CEPI’s COVID-19 vaccine assessment network.
The UK is set to begin COVID-19 human challenge trials in January: aiming to increase understanding of coronavirus and speed up development of vaccine candidates.
UNICEF, the world’s largest single buyer of vaccines, is laying the groundwork for quick and efficient delivery of COVID-19 vaccines by purchasing and distributing more than half a billion single-dose syringes and other critical equipment in countries...
Edesa Biotech, Inc. has received clearance from the U.S. Food and Drug Administration (FDA) to begin the Phase 2 portion of its Phase 2/3 clinical study of its investigational drug, EB05, for the treatment of hospitalized COVID-19 patients.
Enrollment is temporarily on hold in the ACTIV-3 clinical trial, which is evaluating Lilly's investigational neutralizing antibody bamlanivimab (LY-CoV555) as a treatment for COVID-19 in hospitalized patients. The pause was recommended by the study's...
Roche plans to launch its high-volume Elecsys SARS-CoV-2 Antigen test at the end of 2020 in markets accepting the CE mark; while the company will file for Emergency Use Authorisation (EUA) from the U.S. Food and Drug Administration (FDA).
Johnson & Johnson has paused dosing in all its COVID-19 vaccine candidate clinical trials – including its Phase 3 trial – due to an unexplained illness in a study participant.
The US Department of Defense (DoD) and BARDA have expanded a partnership with AstraZeneca (AZ) to develop and manufacture its long-acting antibody (LAAB) combination, AZD7442, that may help treat or prevent infection with SARS-CoV-2.
Contract development and manufacturing organization (CDMO), Cobra Biologics, has been selected to manufacture plasmids for a Phase I clinical trial of a COVID-19 vaccine being developed by UK company, Scancell.
The release of the FDA guidance on emergency use authorization (EUA) for vaccines to prevent the spread of COVID-19 would provide regulatory clarity to scientists and strengthen public confidence in any vaccine authorized by the US regulator, says the...
Two leading clinical research organizations (CROs) say they have identified neutralizing antibodies with great potential for monoclonal antibody treatment.
Axon Neuroscience is launching the world's first crowdfunding exercise for the development of a COVID-19 vaccine, following what it says are strong pre-clinical results for its candidate.
Ena Respiratory’s preventative nasal spray treatment could reach human trials within four months, following results from an animal study released today which showed the spray reduced COVID-19 replication by up to 96%.
AstraZeneca's phase 3 COVID-19 vaccine trial remains on hold in the US as the FDA probe into a patient illness in the UK trial that initiated the global pause continues, the US Department of Health and Human Services Secretary, Alex Azar, told US...
Catalent recently announced that it is investing US$130m in an expansion project at its viral vector manufacturing facility located in Harmans, Maryland, with five new manufacturing suites set to respond to a growing customer pipeline and market demand.
Viral vector production capacity has become increasingly constrained in recent years due to increases in the therapies in development, the dosages given and the patient populations targeted. COVID-19 is exacerbating the situation.
A project run by Gavi, the vaccine alliance, and the World Health Organization (WHO) to guarantee fair access to COVID-19 vaccines worldwide, has secured the backing of 64 higher income countries, with more set to sign up in the coming days.
To accelerate Covid-19 vaccine development, as well as upscale domestic manufacturing capabilities, the German government has announced a €750m (US$890m) fund to support the vaccine programs of three German developers, BioNTech, CureVac and IDT Biologika....
Two US government agencies are investigating whether Moderna Therapeutics, the biotech company behind one of the leading Covid-19 vaccine candidates, was upfront about government funding in its filed or awarded patents, as required by federal law.
AstraZeneca has paused vaccination in all of its Oxford COVID-19 vaccine candidate trials globally, because of a potentially unexplained illness in one of the trials.
The chief executives of nine leading biopharma companies have moved to reassure the public over the development and testing procedures for Covid-19 vaccines.
