GSK plc reports developments across its global biopharma business, including vaccines, respiratory medicines, infectious disease, immunology and oncology programs. Recurring updates include regulatory decisions and clinical evidence for products such as AREXVY, GSK's RSV vaccine, and Exdensur for severe asthma, along with data presentations, product indications and therapeutic-area access initiatives.
GSK news also covers manufacturing and supply agreements, commercial collaborations, public-health grant programs and product partnerships tied to its medicine and vaccine portfolio. As an American Depositary Share issuer, company updates may reflect both parent-company announcements and ADR-related market disclosures.
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.
GSK Consumer Healthcare announced new findings regarding the effects of osteoarthritis (OA) on morning routines, revealing that 67% of Americans with OA struggle to get out of bed due to pain. The study shows that OA significantly impacts daily life, with 56% of those employed reporting lateness to work and over half changing jobs because of pain. To support OA patients, GSK promotes Voltaren Arthritis Pain Gel, a topical NSAID alternative to oral pain relief, and is partnering with the Arthritis Foundation to match donations up to $100,000 this May for Arthritis Awareness Month.
GlaxoSmithKline (GSK) announced FDA approval for JEMPERLI (dostarlimab-gxly), a PD-1 blocking antibody, for treating adult patients with mismatch repair-deficient recurrent or advanced endometrial cancer post-platinum therapy. The approval, based on the GARNET trial, showed an overall response rate of 42.3% among 71 patients, with a durable response in 93.3% of responders for at least 6 months. The treatment is part of GSK's commitment to improving options for patients with this challenging cancer type.
GSK Consumer Healthcare has announced its commitment to reduce plastic in over 80 million Advil bottles by 20%, eliminating nearly 500,000 pounds of plastic waste. By 2022, nearly all Advil bottles will adopt this new sustainable barrier resin technology. This initiative aligns with GSK's broader sustainability goal of making all consumer product packaging recyclable or reusable by 2025. GSK also aims for net-zero climate impact by 2030, having joined the Ellen MacArthur Network to promote a circular economy for plastics.
Viome has appointed Dr. Emmanuel Hanon as Global Head of Research and Development, effective July 1. Dr. Hanon previously served over 20 years at GSK, including senior vice president of vaccine research. He oversaw 3,500 employees across 50 countries, contributing to various vaccine developments. Viome aims to leverage Hanon's expertise in therapeutics to enhance its precision medicine initiatives, focusing on chronic disease prevention through advanced data analytics. CEO Naveen Jain emphasized the importance of understanding root causes of diseases for healthcare transformation.