As the clock ticks down to the US election day on 3 November, President Trump maintains that the first COVID-19 vaccine emergency use approval is imminent. Meanwhile, Fujifilm Toyama's Avigan is near to Japanese approval.
New US guidelines that would raise the efficacy and safety standards required for COVID-19 vaccines to gain emergency use approval are being blocked by the White House.
A report in the New York Times on 5 October backed up earlier reports that the federal government would step in to overrule the US Food and Drug Administration, as the stricter new guidelines would also rule out any
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.
Neurocrine, Madrigal and Vanda updated investors on new drug launches, while Cytokinetics talked to investors about an FDA extension for aficamten.
Vaccine and accelerated approvals are expected to face greater scrutiny under new CBER leader Vinay Prasad, but he has promised “no light switch change” to policy, giving some reassurance to companies whose share prices have been battered.
Workforce development will be essential to meeting president Trump’s goal to return biopharma manufacturing to the US.
