GSK Bio
NEWS
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.
On Friday, the FDA approved Boostrix, a vaccine administered during the third trimester of pregnancy to prevent pertussis in infants under 2 months of age.
GSK reported Wednesday its checkpoint inhibitor Jemperli yielded positive data in non-small cell lung cancer, moving the monoclonal antibody potentially closer to the market in this indication.
The announcement follows a subgroup analysis of the Phase III SOLO3 trial which showed patients treated with Lynparza saw a 33% greater risk of death than controls who received standard chemotherapy.
The FDA will meet Friday to discuss the future of Secura Bio’s Copiktra (duvelisib), which has been approved as a third-line treatment for relapsed or refractory CLL/SLL.
Shares of Spero Therapeutics soared in premarket trading following GlaxoSmithKline’s announcement that it will license the company’s late-stage antibiotic asset, tebipenem HBr.
Several biotech companies backed by billions are working on different approaches to developing the next big anti-aging therapy - from blood experiments to cell reprogramming.
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