AstraZeneca's AZD7442, a long acting antibody (LAAB) combination, achieved a statistically significant reduction in severe COVID-19 or death compared to placebo in non-hospitalised patients with mild-to-moderate symptomatic COVID-19.
A probe has identified 'human error’ at the Spanish contract development and manufacturing organization, Rovi, as the reason for the presence of metal contaminants in Moderna COVID-19 vaccine doses, leading to Japanese authorities withdrawing 1.6...
Pfizer Inc has started a trial to evaluate its investigational oral antiviral drug for the prevention of COVID-19 infection among those who have been exposed to the virus.
CureVac is streamlining its external European manufacturing network for its mRNA product pipeline; having reassessed demand for its first-generation COVID-19 vaccine candidate.
Japan’s health ministry is to secure 150 million doses of Novavax’ vaccine candidate that Takeda is producing. The Japanese government's purchasing agreement is subject to regulatory approvals.
The European Commission and AstraZeneca have settled their dispute over the supply of COVID-19 vaccine, Vaxzevria, in a move that will see the EU receive 200 million doses of the drug maker’s shot by March 2022.
Moderna has initiated its submission to the US Food and Drug Administration (FDA) to support the authorization of a booster dose of its mRNA COVID-19 vaccine at the 50-microgram (mcg) dose level.
The first COVID-19 vaccine drone delivery program in the US was launched last week by North Carolina-based health system, Atrium Health Wake Forest Baptist.
Catalent sees COVID-19 vaccines being an 'enduring and sustainable' revenue stream for the company, particularly with the advent of boosters, and the fact that developing countries, to date, have very low vaccination rates.
The European Medicines Agency’s human medicines committee (EMA CHMP) has this week approved additional manufacturing capacity for Pfizer/BioNTech and Moderna COVID-19 vaccines.
Sweden’s Biotage says its expanded facility in the UK will allow it to triple its production capacity for equipment crucial in the supply chain for the production of mRNA vaccines, and thus eliminating a bottleneck for COVID-19 vaccines.
Earlier this month, Rentschler Biopharma, a contract development and manufacturing organization (CDMO), announced that it had broken ground on its new production facility, adjacent to its existing site in Milford, Massachusetts, in the greater Boston...
There is “sizable demand” from manufacturers of COVID-19 vaccines for vials out to 2023, suggesting that the market will remain significant for some time.
CureVac and GSK said their jointly advanced second-generation mRNA COVID-19 vaccine candidate, CV2CoV, demonstrated improved immune response and protection in a preclinical study.
The World Trade Organization (WTO) Secretariat has published a list of critical inputs for COVID-19 vaccines as part of an effort to address gaps in global production and distribution of the products.
An industry study from the producer of CPhI North America shows the pandemic and other factors are contributing to a very dynamic pharmaceutical market.
The success of mRNA vaccine technology could be one of the new opportunities for US pharmaceutical manufacturing looking forward, with pandemic investments helping turbocharge the sector.
The mRNA vaccine developed by Pfizer and BioNTech generates far higher levels of antibodies against the coronavirus than Sinovac’s inactivated virus prophylactic, according to a study.
The EU Commission has extended vaccination with Moderna’s COVID-19 vaccine to adolescents, following on from the EMA's recommendation in relation to the use of the shot in children aged between 12 and 17.
Celltrion Group has reported that data from an in vivo efficacy study shows that its monoclonal antibody treatment for COVID-19, regdanvimab (CT-P59), has a strong neutralizing effect against the rapidly spreading Delta variant.
A holistic approach to decentralized clinical trials that combines intentional design, stakeholder collaborations, and user-friendly technology is what’s needed to execute global clinical trials more efficiently, argues an expert.
Gavi, which manages COVAX, the global COVID-19 vaccine sharing scheme, says it has secured much-needed vaccines from Chinese producers, Sinovac and Sinopharm.
WHO is recommending the use of interleukin-6 (IL)-6 receptor blockers in patients with severe and critical COVID-19, adding them to its list of treatments for the virus.
The committee for human medicines (CHMP) of the European Medicines Agency (EMA) has approved a scale-up of the active substance manufacturing process at a Janssen Biologics BV site in the Netherlands.
German company, CureVac, says it is in ongoing dialogue with the European Medicines Agency (EMA) and is continuing regulatory submissions on its first-generation mRNA COVID-19 vaccine candidate, CVnCoV.
Moderna says new data indicates its COVID-19 vaccine offers protection against emerging variants, including the seemingly fast spreading Delta variant, first identified in India.
The University of Oxford in partnership with AstraZeneca began vaccinations yesterday for a new phase in human trials to test a COVID-19 vaccine ‘AZD2816’ in volunteers against the Beta [South African] variant.
Augmenta Bioworks and TFF Pharmaceuticals Inc have selected their first lead monoclonal antibody (mAb) for clinical development against COVID-19 as part of their collaborative alliance.
A judgement has been issued in the legal dispute between the European Commission and AstraZeneca over a shortfall of delivery of the company’s COVID-19 vaccine doses to the EU-27.
In recent years, it has become clear that RNA molecules are an emerging as a class of therapeutics of relevance to multiple diseases, most recently including COVID-19 vaccines.
New analysis by PHE shows for the first time that two doses of the COVID-19 vaccines produced by Pfizer and AstraZeneca offer are highly effective against hospitalization from the Delta variant.
