Moderna has submitted a conditional marketing approval (CMA) with the European Medicines Agency (EMA) for the evaluation of a booster dose of the Moderna Covid-19 vaccine (mRNA-1273) at the 50 µg dose level. “We are pleased to submit for a conditional marketing approval with the EMA for our booster candidate at the 50… Read More
The latest DDW Sponsored Sitting Down With podcast features Bryan Jones, Senior Research Fellow, BioTechnology Discovery Research, Eli Lilly and Co and Dan Bedinger, Application Science Team Lead, Carterra. Bamlanivimab was the first neutralising monoclonal antibody to receive emergency use authorisation from the FDA as a treatment for mild… Read More
The National Institutes of Health (NIH) has begun a clinical trial to assess the antibody response to an extra dose of an authorised or approved Covid-19 vaccine in people with autoimmune disease who did not respond to an original Covid-19 vaccine regimen. The trial will also investigate whether pausing… Read More
Japan has suspended the use of around 1.63 million doses of the Moderna vaccine due to contamination, which the health ministry confirmed resulted from “foreign materials” in an unused batch of roughly 560,000 vials, according to BBC reports. According to the news site, Takeda Pharmaceutical, which sells and distributes… Read More
Moderna has completed the rolling submission process for its Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for the full licensure of the its Covid-19 vaccine for active immunisation to prevent Covid-19 in individuals 18 years of age and older. As part of the completed BLA submission, Moderna has requested Priority… Read More
The US Food and Drug Administration (FDA) has approved the Biologics License Application for the Pfizer-BioNTech Covid-19 vaccine. It will now be marketed as Comirnaty for the prevention of Covid-19 disease in individuals 16 years of age and older. It is the first COVID-19 vaccine to be granted approval by the FDA. The vaccine continues to… Read More
Valneva has begun a rolling submission for initial approval of its Covid-19 vaccine candidate, VLA2001, with the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. VLA2001 is a whole virus, inactivated, adjuvanted vaccine candidate and is the only vaccine candidate of this type currently in clinical trials in… Read More
New data has been published on the durability of the Moderna Covid-19 vaccine in generating neutralising antibodies against variants. The manuscript was published in Science. “We are pleased with these new data showing that people vaccinated with two doses of the Moderna Covid-19 vaccine maintained antibodies through six months, including against variants… Read More
Following a thorough review of evidence carried out by the Medicines and Healthcare products Regulatory Agency (MHRA) and recommendation by the Commission on Human Medicines (CHM), the UK government’s independent expert scientific advisory body, the MHRA has approved Ronapreve as the first monoclonal antibody combination product indicated for use in the… Read More
A pilot study has begun to assess the antibody response to a third dose of an authorised Covid-19 mRNA vaccine in kidney transplant recipients who did not respond to two doses of the Moderna or Pfizer-BioNTech Covid-19 vaccine. The Phase II trial is sponsored and funded by the National Institute of Allergy and… Read More
CureVac and GSK have published preclinical data investigating immune responses as well as the protective efficacy of CureVac’s first-generation vaccine candidate, CVnCoV, and second-generation vaccine candidate, CV2CoV, against SARS-CoV-2 challenge in non-human primates. The study, conducted in collaboration with Harvard Medical School, assessed cynomolgus macaques vaccinated… Read More
Moderna has announced that the U.S. Food and Drug Administration (FDA) has approved an update to the emergency use authorisation for the Moderna Covid-19 vaccine (mRNA-1273) to include a third dose for immunocompromised individuals. The third dose will available to people 18 years of age or older in the United… Read More
Mount Sinai researchers have made headway in treating a rare but serious aftereffect of Covid-19 in children, known as multisystem inflammatory syndrome in children or MIS-C. The study was published in Nature Communications. The researchers reported that RNA sequencing of blood samples from the Mount Sinai Covid-19 Biobank led to… Read More
A study led by the University of Birmingham (UK), Keele University (UK) and the San Raffaele Scientific Institute (Italy) has revealed that a licensed drug normally used to treat abnormal levels of fatty substances in the blood could reduce infection caused by the SARS-CoV-2 virus by up to 70%. The… Read More
The drug discovery sector is amazing, says Lu Rahman. And while we have witnessed that on a global scale throughout the pandemic, we should also recognise some of the equally-outstanding non-Covid related developments that have recently taken place. There is, in my opinion, no better industry to be part of at the… Read More
Listen to this article on the DDW Podcast: John Macdonald is Vice President, Venture & Financial Alliances at ICON. He examines the European biotech sector – its expertise and opportunities and potential for growth. By harnessing biological processes on a cellular and biomolecular level, biotech is benefitting industries as varied as… Read More
