GlaxoSmithKline
NEWS
While GlaxoSmithKline is anticipating a slower uptake of respiratory syncytial virus vaccine Arexvy, CEO Emma Walmsley said Wednesday the company is pinning much of its growth on the vaccine’s performance.
The infectious diseases market is expected to reach $150 billion in sales by 2029, with three pharma giants reaping most of its benefits, according to data analytics and consultancy GlobalData.
The FDA’s CBER approved nine novel therapies in the first half of 2023, with several more high-profile decisions on deck for the second half of the year.
Even at its highest dose, Vir Biotechnology’s investigational flu shot failed to significantly outperform placebo at preventing influenza A illness in a mid-stage study.
The company is handing back a multivalent Shigella vaccine candidate to LimmaTech Biologics, which spun out in 2015 after GSK’s acquisition of GlycoVaxyn for $190 million.
The FDA has four target action dates this week for three supplemental approvals and one New Drug Approval.
Preliminary trial results show the GSK five-in-one meningitis vaccine is immunologically effective against the most common strains, as the FDA decision date for Pfizer’s candidate looms.
As the COVID-19 market dries up, Moderna looks to FDA approval of its other vaccines including a 2024 commercial launch of its investigational RSV vaccine for older adults.
The regulatory decision marks a turning point in the RSV race in what’s expected to be a competitive space.
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