Valneva SE commenced rolling submission for initial approval of the company’s COVID-19 vaccine candidate VLA2001 with the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom.
Europe’s drug regulator started a real-time review of the Covid-19 vaccine developed by French drugmaker Sanofi and Britain’s GlaxoSmithKline, the fifth shot currently under such a review as of July 20.
The European Union’s drug regulator said on May 21 a Covid-19 antibody treatment developed by GlaxoSmithKline and Vir Biotechnology can be used to treat patients who are at risk of severe disease and do not need supplemental oxygen.
Europe’s drug regulator said on March 11 it had initiated a rolling review of U.S.-based Eli Lilly’s antibodies to treat Covid-19, days after saying their combination could be used in patients at high risk of progressing to severe illness.
Europe’s drug regulator is evaluating South Korean drugmaker Celltrion’s Covid-19 antibody treatment, the third such drug against the disease to go under real-time review in the region.
CureVac N.V. – a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid – announced initiation of a rolling submission with the European Medicines Agency (EMA) for CVnCoV, an mRNA-based COVID-19 vaccine candidate in late-stage clinical testing.
Moderna and Pfizer-BioNTech are in a tight race to launch their Covid-19 vaccines in Europe after the companies applied for emergency EU approval on Dec. 1, though there was uncertainty over whether a rollout could begin in 2020.
Genentech’s influenza treatment Xofluza (baloxavir marboxil) was granted approval by the U.S. Food and Drug Administration for use in people 12 years and older, making it the first single-dose post-exposure prophylaxis strategy approved by the regulatory agency.
Moderna Inc.’s experimental vaccine is 94.5% effective in preventing Covid-19 based on interim data from a late-stage trial, the company said, becoming the second U.S. drugmaker to report results that far exceed expectations.
Moderna Inc. will soon apply for real-time reviews of the experimental Covid-19 vaccine MRNA-1273 in Europe, the drug developer said, days after the EU health regulator launched rolling reviews of shots from the biotechnology company’s rivals.