US FDA's EUA allows lower doses of the two antibodies than were tested in BLAZE-1, which should extend current supply. With Amgen, Lilly hopes to manufacture 1 million doses by mid-year.
Eli Lilly and Company obtained emergency use authorization in the US on 9 February for its combination of neutralizing antibodies for COVID-19-infected patients, with a reduced infusion time that may make the therapy more suitable for clinician use.
The company said it has 100,000 doses available now of bamlanivimab (LY-CoV555) 700mg and etesevimab (LY-CoV016) 1400mg, with plans to manufacture up to 250,000 doses this quarter with partner
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.
