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.
Valneva SE was awarded Breakthrough Therapy Designation for the company’s single-shot chikungunya vaccine candidate, VLA1553, by the U.S. Food and Drug Administration.
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.
The U.S. Food and Drug Administration issued a Complete Response Letter (CRL) to Merck for the company’s supplemental Biologics License Application for Keytruda (pembrolizumab) in high-risk early-stage triple-negative breast cancer.
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.
The United States Department of Defense (DOD) awarded Moderna a contract valued at $1,966,598,000 for an additional 100 million doses of the company’s Covid-19 vaccine.
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.
