The FDA is set to make a decision on Emergency Use Authorization (EUA) in the coming days for the mRNA COVID-19 vaccine candidate, BNT162b2, from drug makers, Pfizer and BioNTech.
UK company, Spirea, a spin-out from the University of Cambridge, which was founded to deliver the next generation of antibody drug conjugate (ADC) cancer therapeutics, has secured financing from o2h Ventures and Syndicate Room.
The UK’s MHRA says anyone with a history of anaphylaxis should not receive the Pfizer/BioNTech COVID-19 vaccine: following two reports of anaphylaxis and one report of a possible allergic reaction in the first immunizations carried out this week.
Rani Therapeutics, a clinical-stage biopharma company and developer of the RaniPill robotic pill, today announced that it has raised US$69m in a Series E financing round, bringing total funding to date to US$211.
AstraZeneca and the University of Oxford's COVID-19 vaccine candidate threw up a surprise last month when a lower initial dose of the two-dose vaccine showed higher efficacy. More detailed results from this interim analysis, now peer-reviewed and...
As the US FDA advisory committee meets to discuss the merits and risks of Pfizer/BioNTech’s application for emergency use of their COVID-19 vaccine candidate, we talk to two US legal experts to get their perspective on vaccine distribution stateside....
The interim analysis of AZD1222's Phase III trials has been peer-reviewed and published in The Lancet today, demonstrating the vaccine is ‘safe and effective at preventing symptomatic COVID-19 and that it protects against severe disease and hospitalisation’.
The US Food and Drug Administration (FDA) said there are ‘no specific safety concerns that would preclude issuance of an EUA’ for the investigational COVID-19 vaccine (BNT162b2) from US pharma giant, Pfizer, and its German partner BioNTech.
Three studies, which are being presented during the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition, report promising results in the use of cutting-edge genome editing and cellular therapies for hard-to-treat blood disorders and...
UnitedHealth Group is partnering with Eli Lilly and Co to test the efficacy of the Indianapolis-based pharma giant’s COVID-19 monoclonal antibody treatment, bamlanivimab, with patients at the highest risk of adverse outcomes.
New data shows a move towards commercialization and a 48% increase in GMP cell and gene therapy (CGT) manufacturing space in the UK this year despite the COVID-19 pandemic.
