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GSK plc today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted for review the regulatory application of Shingrix (Recombinant Zoster Vaccine or RZV) for the prevention of shingles (herpes zoster) in adults aged 18 years and over at increased risk.
GSK plc today announced results from an interim analysis of the DREAMM-7 phase III head-to-head trial evaluating Blenrep (belantamab mafodotin) combined with bortezomib plus dexamethasone (BorDex) versus daratumumab plus BorDex in second-line and later treatment of relapsed or refractory multiple myeloma. These data will be presented at the American Society of Clinical Oncology (ASCO) Plenary Series on 6 February 2024.
GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has accepted under priority review an application to extend the indication of GSK's adjuvanted respiratory syncytial virus (RSV) vaccine to adults aged 50-59 who are at increased risk for RSV disease. If approved, GSK's RSV vaccine would be the first vaccine available to help protect this population. Arexvy is currently approved in the US in adults aged 60 and over for the prevention of lower respiratory tract disease (LRTD) caused by RSV.
GSK plc (LSE/NYSE: GSK) announced today that the US Food and Drug Administration (FDA) has granted Fast Track designation for bepirovirsen, an investigational antisense oligonucleotide (ASO) for the treatment of chronic hepatitis B (CHB). Fast track designation is intended to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
The designation was requested based on the potential for bepirovirsen to address an unmet medical need for CHB, a serious and life-threatening condition. Data from the phase IIb trials B-Clear and B-Sure, which evaluated the efficacy, safety and durability of response of bepirovirsen in people with CHB, were submitted in support of the application. A confirmatory phase III programme, B-Well, is ongoing.
GSK plc (LSE/NYSE: GSK) today announced that it has completed the acquisition of Aiolos Bio (Aiolos), a clinical-stage biopharmaceutical company focused on addressing the unmet treatment needs of patients with respiratory and inflammatory conditions.
As previously announced,[1] the acquisition of Aiolos includes AIO-001, a potentially best-in-class, long-acting anti-thymic stromal lymphopoietin (TSLP) monoclonal antibody ready to enter phase II clinical development for the treatment of adult patients with asthma. AIO-001 could expand GSK's respiratory biologics portfolio to potentially reach the 40% of severe asthma patients with low T2 inflammation (a type of overactive immune response associated with asthma).[2] AIO-001 has the potential to be administered every six months due to its high potency and long half-life, which could redefine the standard-of-care.
Tony Wood, Chief Scientific Officer, GSK, said: "Given the limited treatment options for asthma patients with low T2 inflammation, we look forward to using our deep respiratory expertise to potentially offer a long-acting biologic to a broader portion of the 315 million patients living with asthma."
ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced results from an interim analysis of the LATITUDE phase III trial, indicating their long-acting injectable antiretroviral treatment (ART) for HIV, Cabenuva (cabotegravir + rilpivirine), demonstrated superior efficacy in maintaining viral load suppression compared to daily oral therapy in individuals with a history of ART adherence challenges.
GSK today announced positive headline results from the pivotal EAGLE-1 phase III trial for gepotidacin, a potential first-in-class oral antibiotic with a novel mechanism of action for uncomplicated urogenital gonorrhoea in adolescents and adults. The trial met its primary efficacy endpoint, with gepotidacin (oral, two doses of 3,000mg) demonstrating non-inferiority to intramuscular (IM) ceftriaxone (500mg) plus oral azithromycin (1,000mg), a leading combination treatment regimen for gonorrhoea. The result is based on a primary endpoint of microbiological response (success or failure) at the Test-of-Cure (ToC) visit 3-7 days after treatment.
GSK plc ) today confirmed it has reached a confidential settlement with Boyd/Steenvoord, resolving the case filed in California state court. The case, which was set to begin trial on 2 April 2024, will be dismissed. The settlement reflects the Company's desire to avoid the distraction related to protracted litigation in this case. GSK does not admit any liability in this settlement and will continue to vigorously defend itself based on the facts and the science in all other Zantac cases.
GSK plc (LSE/NYSE: GSK) announced that ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, today announced positive findings from its phase I study showing that an investigational formulation of cabotegravir, known as cabotegravir ultra long-acting (CAB-ULA), can be dosed at intervals of at least four months. This is the company's first step towards delivering ultra long-acting injectable HIV treatment and prevention medicines that would potentially enable people to have at least four months between visits to the clinic.
GSK plc (LSE/NYSE: GSK) today announced positive headline results from an interim analysis of the DREAMM-8 phase III head-to-head trial evaluating Blenrep (belantamab mafodotin), in combination with pomalidomide plus dexamethasone (PomDex), versus a standard of care, bortezomib plus PomDex, as a second line and later treatment for relapsed or refractory multiple myeloma. The trial met its primary endpoint of progression-free survival (PFS) at a pre-specified interim analysis and was unblinded early based on the recommendation by an Independent Data Monitoring Committee (IDMC).
GSK plc (LSE/NYSE: GSK) today announced statistically significant and clinically meaningful overall survival (OS) results from Part 1 and progression-free survival (PFS) results from Part 2 of the RUBY/ENGOT-EN6/GOG3031/NSGO phase III trial in adult patients with primary advanced or recurrent endometrial cancer. These data were presented today in a late-breaking plenary session at the Society of Gynecologic Oncology 2024 Annual Meeting on Women's Cancer (16-18 March).
The Company's AGM will be held on Wednesday 8 May 2024 at 2.30pm at Royal Lancaster London, Lancaster Terrace, London W2 2TY and will also be broadcast live for shareholders to join electronically. Full details of how to join the meeting either in person or electronically are contained in the 2024 AGM Notice and AGM Guide.
GSK plc today announced that the US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for its 5-in-1 meningococcal ABCWY (MenABCWY) vaccine candidate. The Prescription Drug User Fee Act (PDUFA) action date for a regulatory decision by the US FDA on this application is 14 February 2025.
GSK plc today announced positive data from the ZOSTER-049 long-term follow-up phase III trial which followed participants for up to approximately 11 years following initial vaccination with Shingrix (Recombinant Zoster Vaccine or RZV). The final trial data demonstrate that RZV maintains efficacy against shingles for more than a decade in adults over 50. The data will be presented at ESCMID Global (European Society of Clinical Microbiology and Infectious Diseases) 2024, formerly known as ECCMID in Barcelona, Spain (27-30 April 2024).
GSK plc ( today announced positive results from the pivotal EAGLE-1 phase III trial for gepotidacin, a potential first-in-class oral antibiotic with a novel mechanism of action for uncomplicated urogenital gonorrhoea (GC) in adolescents and adults. These results will be presented on 30 April 2024 at the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Global in Barcelona, Spain.
US FDA accepts for priority review GSK's application for an expanded indication of Jemperli (dostarlimab) plus chemotherapy to include all adult patients with primary advanced or recurrent endometrial cancer.
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