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GSK Presents Positive Phase II Data for mRNA Influenza Vaccine
GSK presented positive phase II data for its mRNA seasonal influenza vaccine candidate at the OPTIONS XIII Conference for the Control of Influenza. GSK's vaccine candidate showed higher immune responses against all influenza strains tested compared to licensed standard dose and high dose inactivated flu vaccines in younger and older adults respectively, and was generally well tolerated. Based on these results, GSK intends to start a phase III efficacy trial in September 2026. This will be the first phase III trial of an mRNA flu vaccine designed to target both haemagglutinin and neuraminidase, the primary surface antigens that cause the flu virus to bind and spread. While licensed flu vaccines primarily target HA, GSK's vaccine candidate is specifically designed to also target NA. Growing evidence suggests this could help improve protection, illness severity and transmission.
ViiV Healthcare Receives FDA Approval for Tivicay PD for Pediatric Use
ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Shionogi as a shareholder, announced that the U.S. FDA has approved Tivicay PD, for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in paediatric patients weighing at least 2 kg. The FDA approval follows Priority Review for this population and is supported by data from the National Institutes of Health-funded IMPAACT 2023 study and pharmacokinetic modelling incorporating additional paediatric data. These data showed that DTG, a second-generation INSTI with a higher barrier to resistance than previous generations, reached therapeutic drug levels in term neonates with a safety profile consistent with that established in older paediatric and adult populations.
GSK Receives Approval for Hibsago as Functional Cure for Chronic Hepatitis B in Japan
GSK announced that Japan's Ministry of Health, Labour and Welfare, MHLW, has approved Hibsago, an antisense oligonucleotide, ASO, as a functional cure for chronic hepatitis B, CHB, virus infection in adult patients who have received at least 6 months of prior nucleos(t)ide analogue therapy and meet pre-defined viral markers. This is the first global approval for bepirovirsen, and the first and only functional cure treatment for CHB approved in Japan. Approval in Japan was supported by results from the B-Well phase III trials showing unprecedented functional cure rates of 19% in adults with less than or equal to 3000 IU/ml HBsAg, compared to current standard of care alone which typically only achieves a 1% functional cure rate after one year of treatment.
GSK's Jemperli Receives FDA Priority Review
GSK announced the US Food and Drug Administration, FDA, has accepted for priority review a supplemental Biologics License Application, sBLA, for Jemperli for patients with previously untreated stage II and III mismatch repair deficient/microsatellite instability-high locally advanced rectal cancer. The FDA has assigned a PDUFA action date of February 2027. The application is also eligible for expedited review through the National Priority Voucher program, which could result in an earlier FDA decision. The application is based on positive data from the registrational phase II, single-arm AZUR-1 trial, which met its primary objective by demonstrating a meaningful and sustained clinical complete response rate for 12 months with no detectable signs of cancer for at least one year.
Trump Signs Vaccine Executive Order Impacting Multiple Companies
Catch up on the top industries and stocks that were impacted, or were predicted to be impacted, by the comments, actions and policies of President Donald Trump with this daily recap compiled by The Fly.VACCINE EO:President Donald Trump signed an executive order proposing to split the MMR vaccine into separate shots, require separate vaccination visits, and overhaul national childhood immunization recommendations into three categories, Bloomberg's Rachel Cohrs Zhang, Jessica Nix, and Josh Wingrove. "There's a reason for such epidemic rates of autism, and we're going to bring it back to much closer to where it was," the president said. "While we do not know exactly what the cause is with respect to autism, it is essential to our research efforts that we have the very best vaccine recommendations in the entire world." Scientific evidence has shown no link between autism and childhood vaccines, and decades of research have failed to identify a singular cause of autism, Bloomberg notes. Publicly traded companies that make vaccines include Johnson & Johnson, Pfizer, BioNTech, Moderna, Novavax, GSK, AstraZeneca, and Emergent BioSolutions.OPENAI, WHITE HOUSE RELATIONSHIP:OpenAI executive Dean Ball's public clash with Trump administration officials over AI regulation has strained the company's relationship with the White House, with officials warning that his hiring could further damage ties, The New York Post's Thomas Barrabi.JONES ACT WAIVER:President Donald Trump has extended a waiver of the Jones Act and narrowed the scope, allowing foreign ships to transport oil and other commodities around the U.S. for 90 more days with new limits, according to Bloomberg, citing a White House official.FUNDING AWARD:Stratasyshas been awarded $7.8M of funding through The 2026 America Makes and the Department of War Organic Industrial Base Modernization Challenge that focuses on advancing additive manufacturing and related technologies to support defense manufacturing modernization. The 24-month award will support development of on-site quality assurance capabilities for Stratasys' F3300 and F900 industrial FDM platforms. This will enable manufacturers to generate the real-time process data needed to scale additive manufacturing production, expand capacity and reduce reliance on costly post-build inspection and qualification.
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