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
Data to establish the safety profile and human dose of vaccine candidate
Blood contains a mixture of exosomes secreted from nearly all tissues and cells, and exosomes from other tissues can mask changes caused by disease, making it difficult to detect the presence of biomarkers that reflect disease
The guidance also urges companies to act quickly to initiate a recall when public health is at risk and to do so prior to completing an investigation into the cause of the problem
In this role, Jeffrey DeAlmeida takes responsibility for BASF’s global pharmaceutical solutions portfolio and the Nutrition & Health business in North and South America
This decision does not impact the ongoing AReSVi 006 phase III trial for RSV older adults.
The company will now be allowed to sell its proprietary and validated tinctures, gummies, and capsules across the UK
With ValGenesis VLMS, change control driven validation activities are reduced from weeks to mere hours, and the company gains faster access to detailed metrics that help reduce costs and cycle time
The partnership will help digitize and automate existing tasks traditionally managed on paper, significantly reducing costs and lead times while increasing compliance
The KRIVIDA Novus RT-PCR kit can detect the Omicron variant, its sub-lineages, and the Delta variant in 45 minutes
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