Welcome to our dedicated page for GSK PLC news (Ticker: GSK), a resource for investors and traders seeking the latest updates and insights on GSK PLC stock.
News and regulatory disclosures for GSK plc (GSK) highlight the company’s ongoing activity across medicines, vaccines and strategic collaborations. As a global biopharma company, GSK regularly reports clinical trial milestones, product approvals, public health initiatives and agreements with partners and governments.
Recent news includes multiple regulatory approvals and data readouts in respiratory medicine. GSK has announced approvals for Exdensur (depemokimab) in markets such as Japan for severe asthma and chronic rhinosinusitis with nasal polyps, based on the SWIFT and ANCHOR phase III trials. The company has also reported that Nucala (mepolizumab) was approved in China as an add-on maintenance treatment for adults with COPD characterized by raised blood eosinophils, supported by the MATINEE and METREX studies.
In vaccines, GSK issues updates on Shingrix, including US FDA and European Commission approvals of a prefilled syringe presentation designed to simplify administration, and on its seasonal influenza vaccines FLULAVAL and FLUARIX, which are shipped ahead of each US flu season following FDA lot-release. News about Vaccine Track, GSK’s public data tool for US adult immunization trends, provides additional context on the company’s role in vaccination and public health analytics.
Oncology and specialty medicine updates feature prominently in GSK news. The company has reported US FDA approval of Blenrep in combination regimens for relapsed or refractory multiple myeloma, as well as positive phase III results for bepirovirsen in chronic hepatitis B with plans for global regulatory submissions. Additional releases describe collaborations with partners such as Hengrui Pharma and Summit Therapeutics to develop new respiratory, immunology & inflammation and oncology programs.
Investors and observers following GSK news can expect coverage of clinical trial outcomes, regulatory decisions, pricing and access agreements, and community initiatives such as the Linked by Lupus: Optimal Care Initiative. Bookmarking this page provides a centralized view of GSK’s latest announcements and SEC-reported developments.
ViiV Healthcare launched a report in collaboration with Economist Impact, outlining actions to eliminate health disparities related to HIV, STIs, mental health, and COVID-19 in the US and UK over the next 20 years. The study highlights that current healthcare inequities are both avoidable and costly, urging stakeholders to adopt a cohesive approach towards health equity. Key recommendations include restructuring healthcare systems for prevention, reimagining investments, enhancing collaboration, and better targeting of interventions aimed at vulnerable populations.
ViiV Healthcare presented three-year findings from the Phase III TANGO study, demonstrating that the 2-drug regimen Dovato (dolutegravir/lamivudine) is non-inferior to the three-drug TAF-based regimens for HIV-1 patients. No virologic failures occurred in the Dovato group (0% vs <1% with TAF), reinforcing its viability as a treatment option. Notably, patients on Dovato displayed better management of fasting lipids. Overall adverse event rates were similar, with Dovato showing marginally higher drug-related AEs. This study was crucial in establishing Dovato's long-term effectiveness.
GSK Consumer Healthcare has launched Sensodyne Repair and Protect with Deep Repair, just in time for National Coffee Day on September 29, 2021. This new toothpaste is specially formulated for individuals with tooth sensitivity, allowing them to enjoy their favorite hot beverages without discomfort. According to a survey, 43% of people prefer hot coffee. Sensodyne's new product offers clinically significant sensitivity relief and additional benefits including cavity protection and whitening. The product is available at major retailers and online.
ViiV Healthcare announced that the FDA has accepted and granted Priority Review for its New Drug Application (NDA) for cabotegravir long-acting, intended for HIV pre-exposure prophylaxis (PrEP). If approved by the target date of
ViiV Healthcare has announced a collaboration with Shionogi for S-365598, a third-generation HIV treatment aimed at ultra long-acting regimens. The agreement includes an upfront payment of £20 million and additional milestone payments totaling £15 million, alongside royalties on sales. Preliminary data suggest S-365598 could offer a distinct resistance profile and longer dosing intervals, enhancing patient adherence. Clinical studies are expected to start by 2023. This partnership aims to strengthen ViiV's pipeline for innovative therapies beyond 2030.
GlaxoSmithKline (GSK) has received FDA approval for Nucala (mepolizumab) as an add-on treatment for chronic rhinosinusitis with nasal polyps (CRSwNP) in adults over 18. This biologic is now the first anti-IL-5 option available for this condition, which affects over 5 million people in the US. The approval is based on the SYNAPSE study, which showed a 57% reduction in surgery rates for patients treated with mepolizumab versus placebo. The drug is already approved for other eosinophilic diseases, reinforcing GSK's commitment to managing eosinophilic inflammation.
On July 26, 2021, GlaxoSmithKline announced FDA approval for Shingrix to prevent shingles in adults aged 18+ at increased risk due to immunodeficiency. This approval expands its use beyond those 50 and older, targeting immunocompromised patients, including transplant recipients and those with hematological malignancies. The clinical development program assessed Shingrix's safety and efficacy in these populations. The CDC's Advisory Committee on Immunization Practices is reviewing usage recommendations for this group. GSK aims to remind adults over 50 of missed vaccinations during the pandemic, as over 100 million are recommended for Shingrix.
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ViiV Healthcare and Halozyme Therapeutics have formed a collaboration to utilize Halozyme's ENHANZE® drug delivery technology for HIV treatment and prevention. ViiV will pay Halozyme $40 million upfront, with potential future payments totaling $175 million based on development milestones. This partnership aims to develop ultra-long acting HIV medicines, reducing the treatment burden for patients. Halozyme's enzyme technology enables rapid delivery of large volumes of medication, potentially extending dosing intervals beyond current standards. The collaboration could lead to innovative options in HIV therapies.
GSK Consumer Healthcare announced a partnership with actor Anthony Anderson for the #AfterMyShot campaign, aimed at helping individuals manage post-COVID-19 vaccine side effects. Advil, a leading OTC pain reliever, will support those experiencing common side effects like aches or fever after vaccination. Anderson shares his personal experience using Advil post-vaccine and encourages others to share their stories. GSK emphasizes its commitment to pain relief with trusted brands like Advil, Panadol, and Voltaren, helping people enjoy life fully after vaccination.