Johnson & Johnson says it is preparing to resume recruitment in its Phase 3 Janssen COVID-19 vaccine trial in the US: after the trial was paused because of an unexplained illness earlier this month.
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.
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...
Potential vaccines for COVID-19 should not be affected by changes in SARS-CoV-2 seen to date, nor are they likely to need to be redeveloped seasonally, according to Australian scientists.
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...
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.
A contract between the EU and Janssen Pharmaceutica NV will see Janssen supply 200 million doses of a COVID-19 vaccine, with the potential for an additional 200 million doses.
On Tuesday the FDA released its guidance on Emergency Use Authorization for COVID-19 vaccines: a move welcomed by the industry as a ‘tried and true tradition of releasing guidance in a public and transparent way’.
Fujifilm is boosting its gene therapy offering, taking the first steps to expand its viral vector contract development and manufacturing organization (CDMO) services to Europe, at the site of Fujifilm Diosynth Biotechnologies (FDB) in the North East of...
The UK’s Vaccines Manufacturing & Innovation Centre (VMIC) announces that the UK Medicines & Healthcare products Regulatory Agency (MHRA) has approved the second of two GMP COVID-19 vaccine manufacturing suites located at Oxford Biomedica's...
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.
The Serum Institute of India will receive six 4,000L CSR bioreactors from ABEC to help it scale up manufacture of Novavax’s COVID-19 vaccine candidate.
Symbiosis Pharmaceutical Services reported a successful audit outcome by the UK government regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) for its Scottish production site.
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...
Johnson & Johnson has launched its pivotal global Phase 3 trial for its COVID-19 vaccine candidate: anticipating the first batches of its vaccine will be available for emergency use authorization in early 2021.
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.
AstraZeneca paused its COVID-19 vaccine trial earlier this month for a safety review – generating headlines across mainstream press worldwide. Such pauses are not uncommon in clinical trials – so what’s the best way to deal with them?
BioNTech will acquire Novartis’ GMP certified manufacturing facility in Marburg, Germany: with the site set to become one of the largest mRNA manufacturing plants in Europe.
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....
Cytiva is to invest US$500m over the next five years to raise manufacturing capacity, hiring nearly 1,000 personnel in Austria, China, Singapore, Sweden, and the US, and bringing on new manufacturing lines, 24/7 shift patterns, and increased automation.
Transporting a COVID-19 vaccine to 7.8 billion people around the world would fill 8,000 jumbo jets – illustrating the enormity of the distribution challenge. The International Air Transport Association (IATA) warns of potential capacity constraints,...
The European Commission has concluded exploratory talks with BioNTech-Pfizer to purchase up to 300 million doses of a potential vaccine against COVID-19.
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.
The chief executives of nine leading biopharma companies have moved to reassure the public over the development and testing procedures for Covid-19 vaccines.
The Australian Government has made a $1.7bn AUD ($1.24bn USD) supply and production agreement for COVID-19 vaccines: with the first doses set to come from AstraZeneca’s vaccine in January 2021.
