News & Analysis on the Clinical Development and Manufacture of Large Molecule Drugs
Akston Biosciences has announced a strategic partnership with LakePharma to manufacture commercial quantities of its COVID-19 vaccine candidate, as the room temperature stable vaccine gears up to begin Phase 1/2 clinical trials this month.
The US FDA has emphasized it will not make any changes to the recommended dosing of authorized COVID-19 vaccines: saying any modifications would create a ‘significant risk’ of undermining vaccination efforts.
Israel’s Ministry of Health (MOH) has authorized the use of Moderna’s COVID-19 vaccine in that country.
Preclinical contract research organization (CRO), Charles River Laboratories International, has announced the acquisition of an antibody discovery company, Distributed Bio, for US$83m in cash.