GSK Bio

NEWS
GSK scored a pivotal Priority Review from the FDA for its RSV vaccine candidate for older adults, which will expedite regulatory evaluation of its clinical data.
GSK is pulling the plug on an experimental monoclonal antibody therapy for rheumatoid arthritis following a significant miss in one of three Phase III trials.
FDA
An FDA adcomm that met Wednesday to vote on GlaxoSmithKline’s daprodustat for adult patients with anemia due to chronic kidney disease (CKD) produced mixed results.
GSK terminated its cell therapy pact with Lyell Immunopharma. It’s opting to advance its own programs without use of Lyell’s T-cell modulating technologies that were at the center of the partnership.
Genetic engineering company Empyrean Neurosciences stepped into the CNS arena with $22 million and a small molecule platform derived from plants and fungi.
GlaxoSmithKline (GSK) announced Tuesday morning it has struck a $70 million deal with Tempus in exchange for expanded access to Tempus’ AI-based patient data platform.
Novartis, GlaxoSmithKline and Sanofi have announced plans for significant cutbacks and changes in their labor force overseas for financial, operational and logistical reasons.
The FDA has numerous activities and interactions with Phanes, Prestige Biopharma, Reata, Pfizer and more, providing clearance, approving clinical trials and other regulatory actions.
GSK’s RSV vaccine candidate met its primary endpoint in a pivotal Phase III trial, proving to be highly effective against RSV-associated lower respiratory tract disease.
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