NEW YORK, Dec. 02, 2020 (GLOBE NEWSWIRE) — Mesoblast Limited(Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that the United States Food and Drug Administration (FDA) has granted Fast Track designation for remestemcel-L in the…
UK approves Pfizer-BioNTech COVID-19 vaccine; rollout to begin next week
The United Kingdom has become the first country to authorise the Pfizer-BioNTech COVID-19 vaccine for use. Britain on December 2 said that the COVID-19 vaccine will be rolled out for use from next week. The emergency authorization clears the way for the deployment…
Creating a Compliant eCTD: Avoiding Frequent Regulatory and Technical Pitfalls
The Electronic Common Technical Document (eCTD) is the standard format for submitting applications, amendments, supplements, and reports to the U.S. Food & Drug Administration (FDA). The eCTD harmonizes the regulatory review process for global drug development, as its structure is…
COVAXX Announces $2.8 Billion in Advance Purchase Commitments to Deliver More Than 140 Million Vaccine Doses to Emerging Countries
HAUPPAUGE, N.Y.–(BUSINESS WIRE)– COVAXX, a U.S. company developing a multitope peptide-based vaccine to fight COVID-19, announces advanced purchase commitments of more than 140 million doses of its UB-612 vaccine, totaling over $2.8 billion, to deliver vaccines in multiple countries, including…
EU secures 160 million doses of Moderna’s COVID-19 vaccine
BRUSSELS (Reuters) -The European Union has struck a deal for up to 160 million doses of U.S. firm Moderna’s COVID-19 vaccine candidate, the head of the European Commission said on Tuesday, taking the EU’s potential stock of COVID-19 shots to…
FDA issues 34 new and revised product-specific guidances
In its latest quarterly release of product-specific guidances meant to promote the development of generic drugs, the US Food and Drug Administration (FDA) on Wednesday posted 13 new and 21 revised draft guidances, bringing the total number of such guidances…
Oxford-AstraZeneca Covid vaccine shows robust immune response among older adults
KEY POINTS The study of 560 healthy adults, including 240 over the age of 70-years-old, found the vaccine to be safe and produced a similar immune response among people aged over 56-years-old and those aged between 18 and 55. British…
WHO advises against use of remdesivir to treat hospitalised Covid patients
The World Health Organization recommended against using Gilead Sciences Inc.’s remdesivir to treat hospitalized Covid-19 patients less than a month after U.S. regulators granted the drug a speedy approval. “There is currently no evidence that it improves survival or the…
Anti-COVID-19 nasal spray ‘ready for use in humans’
A nasal spray that can provide effective protection against the COVID-19 virus has been developed by researchers at the University of Birmingham, using materials already cleared for use in humans, the varsity said on Thursday. A team in the University’s…
Moderna: Covid vaccine shows nearly 95% protection
A new vaccine that protects against Covid-19 is nearly 95% effective, early data from US company Moderna shows. The results come hot on the heels of similar results from Pfizer, and add to growing confidence that vaccines can help end…
