COVID-19
The regulator’s restrictions come as the U.S. is experiencing a surge in cases. Invivyd also announced updated Phase III data for Pemgarda, touting an 84% relative reduction in symptomatic COVID-19.
The company joins Eli Lilly in offering its own digital platform to more directly connect to patients, allowing them easier access to healthcare providers and prescription drugs.
The vaccine maker is competing with well-established rivals in markets that have a mix of demand issues as well as commercial and structural headwinds, as the biotech looks to establish new growth drivers.
The regulator on Thursday said the mRNA vaccines, Pfizer-BioNTech’s Comirnaty and Moderna’s Spikevax, will better protect against currently circulating variants as COVID continues to surge in many parts of the U.S.
The companies’ late-stage stumble could allow Moderna to widen its lead, with its mRNA-based combination vaccine eliciting superior immune responses against COVID-19 and three influenza strains.
While some biopharma companies beat expectations, others fell short for various reasons, with some deciding to return or axe assets.
The vaccine maker on Thursday reported $415.5 million in total revenue in the second quarter, lower than the analyst consensus of $458.6 million.
BioNTech on Monday reported nearly $885 million in losses in the second quarter of 2024, compared to $208.5 million during the same period last year.
GSK, Moderna and Pfizer are all looking at potential respiratory syncytial virus vaccine sales slumps thanks to recently updated CDC guidelines regarding the use of RSV shots in seniors.
As part of a major reorganization, Vir Biotechnology has discontinued the bulk of its virology work and pivoted to cancer in an exclusive licensing deal with Sanofi.
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