Revamped Manufacturing Process Yields Fast-Track Ryplazim Approval Three Years Later
Executive Summary
Plasminogen therapy for unmet need licensed after Prometic took the time to develop a manufacturing process it could validate.
You may also be interested in...
Keeping Track: US FDA Approval Binge Includes Brexafemme, Wegovy, Ryplazim, Truseltiq, Lybalvi, Tembexa
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
FDA Warning Letter Brings Another High-Flying Emergent CDMO Plant Down To Earth
Warning letter reveals agency found quality problems at Emergent BioSolutions’ Camden fill/finish plant during COVID-19 pandemic even as firm’s Bayview plant came under heightened scrutiny. Metal particulates appeared in vials as Camden plant and rest of Emergent’s CDMO network experienced sharp demand growth.
Challenges And Opportunities As mRNA Manufacturing Spreads Its Wings Beyond COVID-19 Vaccines
In the second part of In Vivo's series on mRNA manufacturing, we look at the technology behind the Moderna and Pfizer/BioNTech COVID-19 vaccines. Experts in the field are working on a variety of improvements that will enable quicker, cheaper, surer development and production of what could turn out to be a wide array of vaccines and therapeutics to be churned out by emerging mRNA platforms.