News & Analysis on the Clinical Development and Manufacture of Large Molecule Drugs
Biotech company, Vaxxas, has secured a partnership agreement with the Coalition for Epidemic Preparedness Innovations (CEPI) to advance the development of its needle-free vaccine-patch delivery technology for mRNA vaccines.
The unprecedented rise in approvals for new cell and gene therapies, and the increasing industry need for cell lines to support the production of therapeutics, has spurred US CDMO, the Center for Breakthrough Medicines (CBM), to act
Janssen’s experimental HIV vaccine regimen was found to be safe but ineffective in the Phase 3 Mosaico clinical trial: and as a result the company is discontinuing the study.
An agreement between the two countries means they can use each other’s good manufacturing practice inspections of pharmaceutical manufacturing facilities and avoid the need for duplicate inspections.
The candidate reported efficacy of 83.7% against RSV-associated lower respiratory tract disease: with Moderna set to file for regulatory approval for the vaccine within the first half of this year.