The FDA has released detailed guidance to COVID-19 vaccine manufacturers setting out the safety and efficacy standards required, and pledged to not cut corners.
The US Food and Drug Administration commissioner Stephen Hahn has pledged that the agency will not lower its safety and efficacy standards in order to approve quickly any COVID-19 vaccine.
Hahn was giving testimony to the Senate Health, Education, Labor and Pensions Committee in Washington DC at a hearing on 30 June, and made a point of
Kostaive is the first self-amplifying mRNA COVID-19 vaccine to receive approval from the European Commission and could provide serious competition to Pfizer/BioNTech's Comirnaty and Moderna's Spikevax.
A week after a downbeat forecast at J.P. Morgan Healthcare Conference, the US mRNA specialist has pocketed another sizeable sum from the US Department of Health and Human Services to accelerate development of an H5N1 mRNA pandemic influenza vaccine.
Pfizer’s and Moderna’s quarterly pandemic-related product sales could not mask other weaknesses while GSK’s quarter was marred by unimpressive non-pandemic vaccines sales.
Japanese distributor Meiji Seika Pharma is considering possible legal action against what it views as online slander around COVID-19 vaccine Kostaive, which received its global-first approval in Japan last year and has now been launched for regular vaccination in the country.
Company surprises investors with Jørgensen's exit but insists its strategy will not change.
The US regulator’s decision has taken Biohaven and investors by surprise, with the reason for a ‘major amendment’ status not clear.
Recent moves in the industry include changes at the top at Akamis Bio, Innospera Pharma & Ispen, plus Astellas Korea appoints an ex-Novartis Korea executive.
