Regeneron’s casirivimab and imdevimab antibody cocktail (formerly known as REGN-COV2 or REGEN-COV2), has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA).
Eli Lilly and Company's neutralizing antibody bamlanivimab (LY-CoV555) has received interim authorization from Health Canada as a treatment for COVID-19.
AstraZeneca says interim analysis of clinical trials in the UK and Brazil of its candidate COVID-19 vaccine being developed in partnership with the University of Oxford - AZD1222 - showed the vaccine was highly effective in preventing COVID-19, the primary...
The European Commission has granted a marketing authorization for Sanofi’s Supemtek, a quadrivalent (four-strain) recombinant influenza vaccine: representing the first and only recombinant influenza vaccine approved in the European Union.
It’s been a big week for mRNA-based COVID-19 vaccines: with both Pfizer/BioNTech and Moderna reporting impressive efficacy for their COVID-19 vaccine candidates. Here's five key takeaways from this week's developments.
How prepared is the existing global cold chain, and especially refrigerated transport, to cope with the full temperature ranges required for the multiple COVID-19 vaccine candidates? A cold chain expert responds.
The COVID-19 pandemic is expected to continue to impose enormous burdens on societies and economies globally. While governments are now getting ready to ensure large-scale distribution of a vaccine, concern about vaccine hesitancy is growing worldwide....
Pfizer has revised the efficacy figures for its COVID-19 vaccine candidate – now stating the vaccine is 95% effective – with its Phase 3 study meeting all primary efficacy endpoints.
Vibalogics has announced it is expanding its global footprint with a late phase clinical and commercial manufacturing facility near Boston, Massachusetts, a major milestone as it looks to advance its services to drug developers across the globe.
The European Commission has reached an agreement with CureVac for up to 405 million doses of its mRNA-based COVID-19 vaccine candidate: representing the biggest COVID-19 vaccine deal the Commission has inked so far.
Johnson & Johnson has launched a second global Phase 3 trial for its Janssen COVID-19 vaccine candidate: this time exploring a 2-dose regimen (its existing Phase 3 trial is for a 1-dose regimen).
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published three new Official Control Authority Batch Release (OCABR) guidelines in preparation for the first three vaccines likely to be launched in Europe.
The clear evidence of increased risk of COVID-19 infection amongst ethnic minority groups, people from Black and Asian backgrounds, is of urgent public health importance, according to the authors of a paper published today by The Lancet.
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,...
The European Directorate for the Quality of Medicines and Healthcare (EDQM) has published a text on analytical strategy options for the control of COVID-19 recombinant viral vectored vaccines.
Sanofi is eying up the European biopharmaceutical company’s proprietary next generation natural killer (K-NK) cell platform and pipeline of cell-based cancer immune-therapeutics and infectious disease therapies.
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.
Novavax’s Phase 3 COVID-19 vaccine trial in the UK has been expanded to 15,000 participants; while a 30,000 strong Phase 3 clinical trial is due to start in the US and Mexico next month.
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.
