OR WAIT null SECS
February 10, 2021
Lessons learned from the pandemic can advance future biologic drug development and manufacturing.
The agency is developing guidance to help manufacturers make changes to existing COVID-19 vaccines to treat new variants in the coronavirus.
February 05, 2021
FDA’s Vaccines and Related Biological Products Advisory Committee will meet on Feb. 26, 2021 to discuss the request for emergency use authorization for Janssen Biotech’s COVID-19 vaccine candidate.
February 04, 2021
The CGMP manufacturing agreement will expand production of lenzilumab, a candidate for COVID-19 therapy, to support a potential emergency use authorization filing.
February 03, 2021
Both companies will provide resources and expertise to research, develop, and manufacture multiple mRNA vaccine candidates, including multi-valent and monovalent approaches.
Plasma-based proteins and cell-based therapies have significant potential to address unmet medical needs.
Rapid growth in biologics and increasing complexity of new compounds are some of the factors driving development of innovative delivery solutions.
Advanced manufacturing technologies are available, but challenges need to be addressed.
Viewpoint: Continued dialogue among pharma stakeholders is needed to achieve consensus regarding excipient composition.
February 02, 2021
The EC intends to get tougher on issues such as reliability of drug supplies, particularly essential medicines.
