News | February 23, 2023
Research underscores Beyfortus’ potential to prevent RSV disease in infants
The new Beyfortus data are consistent with all data accumulated to date and confirm its strong profile
The new Beyfortus data are consistent with all data accumulated to date and confirm its strong profile
The company remains committed to maintain the highest standards of compliance and will work closely with the agency to comprehensively address all the observations
Nirsevimab is the first investigational immunization designed to protect all infants across the RSV season with a single dose
The companies are now preparing to initiate a Phase 1 trial to assess the safety and immunogenicity of BLB-201 in healthy volunteers
The FDA decision is primarily informed by the positive results of a proof-of-concept, Phase 2a study evaluating the safety, immunogenicity, and efficacy of a single dose of 120µg RSVpreF in a human viral challenge model in healthy adults 18 to 50 years of age
This decision does not impact the ongoing AReSVi 006 phase III trial for RSV older adults.
Market data indicates that more than twenty percent of the new chemical entities being developed use roller compaction technology in their development and commercialization
RSV is a common and pervasive cause of severe acute respiratory illness in older adults with no vaccine currently available
Data highlight ambition to transform prevention and treatment for serious bacterial infections and develop novel preventative strategies for respiratory viral infections
Groundbreaking collaboration harnesses AI-driven insights and advanced manufacturing to create next-generation adjuvants for emerging biological threats
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