GSK pledges $800M to add biologics production capabilities in Pennsylvania

The FDA approved Hibsago, a new hepatitis B treatment developed by GSK and Ionis. In trials, 19% of patients maintained virus control for 24 weeks post-treatment. It's for adults without cirrhosis, with specific viral load and antigen levels. The FDA warned of potential severe side effects, including hepatic reactions and low platelet counts.

The FDA approved dolutegravir, an HIV treatment, for newborns based on an international study. The study, involving UC San Diego and Boston Medical Center, found a safe dosing regimen for infants. The approval expands treatment options for HIV-infected newborns, according to the researchers.

GSK and Ionis' Hibsago (bepirovirsen) received FDA approval for chronic hepatitis B, offering a functional cure. Analysts at H.C. Wainwright see this as a significant milestone, opening the market for competitors like Gilead, Arrowhead, and Aligos. The drug is approved for a specific patient population, leaving opportunities for other therapies. Several companies will present data at the AASLD meeting in November.

The FDA approved GSK's Hibsago (bepirovirsen) for chronic hepatitis B, the first antisense oligonucleotide for this use. It's for adults without cirrhosis who meet specific criteria. In trials, 19% of patients controlled the virus 24 weeks post-treatment. The drug carries a boxed warning for serious liver reactions and low platelet counts, requiring regular monitoring. Pricing and coverage details are not yet available.

GSK's Hibsago received FDA approval for chronic hepatitis B in adults. Phase III trial showed 19% functional cure rate. Jemperli approved for rectal cancer. GSK plc Sponsored ADR (GSK) benefits from these regulatory wins.

Ionis Pharmaceuticals' partner GSK received FDA approval for HIBSAGO (bepirovirsen), showing a 19% functional cure rate in Phase 3 trials for chronic hepatitis B. The approval was granted under priority review and Breakthrough Therapy Designation. Ionis is eligible for milestones and royalties. The label includes safety warnings.