Search Results for “GSK ” – Page 5 – media

GSK’s RSV vaccine approved by FDA for older adults

GSK’s respiratory syncytial virus (RSV) vaccine has been approved in the US for the prevention of RSV-caused lower respiratory tract disease (LRTD) in adults aged 60 years and older. The US Food and Drug Administration’s (FDA) decision makes Arexvy the first RSV vaccine for older adults to be approved anywhere in the world. RSV is a common contagious virus characterised by several mild, cold-like symptoms. Although most people can recover within a week or two, older adults are at a high risk for severe disease. This is partly due to age-related decline in immunity. RSV can also exacerbate other conditions, including chronic obstructive pulmonary disease, asthma and chronic heart failure. Overall, RSV infections in older adults account for over 170,000 hospitalisations and approximately 14,000 deaths each year in the US. The company’s application was supported by positive results from its phase 3 AReSVi-006 trial, in which the vaccine showed ...
- Source: drugdu
- 143
- May 12, 2023
GSK to buy Bellus Health and its chronic cough drug for $2B

GSK on Tuesday said it will pay $2 billion to acquire Bellus Health, a Canada-based developer of an experimental drug for chronic cough that’s in late-stage clinical trials. Deal terms value each Bellus share at $14.75, roughly double their closing price on Monday. The companies expect the acquisition will close in the third quarter, and Bellus’ board has unanimously voted in its favor. Bellus’ drug, called camlipixant, is currently being tested in two Phase 3 studies of people with persistent cough that either doesn’t have a clear cause or can’t be relieved by treatment for an underlying condition. Results are expected in late 2024 and in 2025, respectively. With the Bellus deal, GSK will gain a drug that could compete with a similar treatment being developed by Merck & Co. Both medicines are designed to work by targeting a receptor known as P2X3, and could become the first ...
- Source: drugdu
- 350
- April 20, 2023
GSK outlines deal to send cell therapies back to Adaptimmune

The pharma is handing back two experimental cancer medicines amid a retreat from cell therapy research. GSK has outlined a deal to send two cancer immunotherapies back to biotechnology company Adaptimmune Therapeutics, a move that follows the larger drugmaker’s recent decision to stop investing in cell and gene therapy research. Adaptimmune announced last October that it would regain rights to the two programs, each of which are in development for solid tumors. On Tuesday, the biotech revealed terms of the agreement. It will get about $37 million in cash from GSK, and receive all materials, data and trial sponsorship responsibilities related to the drugs later this year. The agreement will formally end a partnership between GSK and Adaptimmune that dates back to 2014. That year, the two began working on a program called lete-cel, which works by genetically modifying cells to detect NY-ESO, a protein expressed on several ...
- Source: drugdu
- 262
- April 12, 2023
GSK will have to pay additional royalties to AstraZeneca on cancer drug Zejula

[GSK already has concerns with cancer drug Zejula, which is under scrutiny as a member of the PARP inhibitor class. Not the company has taken a loss in court as it will have to surrender added royalties to AstraZeneca for the drug which rolled up sales of 463 pound sterling ($571 million) last year. (GSK)] When Emma Walmsley took over as CEO at GSK in 2017, one of her first moves was to beef up the company’s oncology portfolio with a $5.1 billion acquisition of cancer specialist Tesaro and its newly approved drug Zejula. The ovarian cancer treatment generated 463 pound sterling ($571 million) in 2022, representing a 17% increase from the previous year. So far, so good, right? Well, not exactly. After losing a patent case in court on Wednesday, GSK will have to surrender a portion of its sales of Zejula to Tesaro’s partner on ...
- Source: drugdu
- 157
- April 6, 2023
GSK reports positive phase 3 results for five-in-one meningococcal vaccine candidate There are currently no licensed vaccines offering simultaneous protection against all five serogroups

GSK has reported positive top-line results from a phase 3 study of its five-in-one meningococcal vaccine candidate, MenABCWY, in healthy individuals aged ten to 25 years. Invasive meningococcal disease (IMD) is an uncommon but serious illness that can cause life-threatening complications or even death, with the highest incidence occurring in children and adolescents. Five Neisseria meningitides serogroups – A, B, C, W, and Y – account for nearly all IMD cases, but there are currently no licensed vaccines that offer simultaneous protection against all of them. In the US, two separate vaccines needing four injections are required to protect against all five serogroups. This regimen, together with low awareness of the disease, can lead to poor immunisation rates, with an estimated coverage of only 31% of adolescents in the US. It is hoped that GSK’s MenABCWY, which combines the antigenic components of its licensed Bexsero (MenB) and Menveo (MenACWY) meningococcal ...
- Source: drugdu
- 154
- March 27, 2023
China’s NMPA accepts GSK’s drug application review for Nucala to treat SEA

China National Medical Products Administration has accepted the review of GSK’s drug application for Nucala (mepolizumab) as an add-on maintenance treatment for severe eosinophilic asthma (SEA). If given approval, Nucala will become the first targeted anti-Interleukin-5 (IL-5) treatment in the country for adult and adolescent patients with SEA. A first-in-class monoclonal antibody to target IL-5, Nucala was first approved in 2015 for SEA in the US. It prevents IL-5 from binding to its receptor on the surface of eosinophils, lowering blood eosinophils and maintains them under normal levels. The application to China National Medical Products Administration has been submitted based on positive data from Phase III trial undertaken on patients in China and the global SEA development programme, which included three important clinical trials – DREAM 2, MENSA3 and SIRIUS4. These trials established the efficacy and safety profile of mepolizumab for SEA patients. The Phase III trial for 52 weeks studied the ...
- Source: drugdu
- 131
- March 16, 2023
Chasing Pfizer, GSK’s 5-in-1 meningococcal vaccine delivers phase 3 trial win

Nearly three years after dosing the first patient in a phase 3 trial, GSK has now reported positive results from the trial of its much-anticipated combination meningitis vaccine. The shot, a combination of GSK’s approved vaccines Bexsero and Menveo, targets meningitis and blood poisoning caused by the A, B, C, W, and Y groups of meningococcal bacteria. The serogroups A, B, C, W and Y cause nearly all invasive meningococcal disease (IMD) cases globally, GSK said in a statement. As it stands now in the U.S., protection from all five groups requires four injections from two separate vaccines. But GSK is looking to change that with its two-dose shot, which is administered six months apart. GSK said that the vaccine candidate met endpoints in the trial, which enrolled healthy people between 10 and 25 years of age. The vaccine matched up to Bexsero and Menveo, eliciting a “clinically meaningful immune response.” https://www.fiercepharma.com/pharma/gsks-combination-menabcwy-vaccine-holds-its-own-against-gsks-approved-meningitis-jabs
- Source: drugdu
- 128
- March 16, 2023
GSK’s PD-1 inhibitor Jemperli approved in the UK

GlaxoSmithKline’s (GSK) PD-1 inhibitor Jemperli has been authorised by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of recurrent or advanced endometrial cancer. Specifically, Jemperli (dostarlimab) has been granted a conditional marketing authorisation for use in adult patients with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) recurrent or advanced endometrial cancer, who have progressed on or following prior treatment with a platinum containing regimen. The authorisation is based on results from the open-label GARNET study, which included women with recurrent or advanced dMMR/MSI-H endometrial cancer who progressed on or after a platinum-based chemotherapy regimen. Jemperli treatment led to an objective response rate of 44.8% and a disease control rate of 57.1%, while a median duration of response (DoR) had not been reached in these patients. However, the probability of maintaining a response at six months and 12 months was 97.9% and 90.9% respectively, according to ...
- Source: drugdu
- 287
- June 7, 2021
Jemperli
NICE turns down GSK’s IV Benlysta for systemic lupus

The National Institute for Health and Care Excellence (NICE) has rejected NHS funding for an intravenous formulation of GlaxoSmithKline’s Benlysta (belimumab) as an add-on therapy for certain patients with active autoantibody-positive systemic lupus. The preliminary decision, outlined in an appraisal consultation document, relates to use of the drug in people aged five years and older when there is a high degree of disease activity (for example, positive anti-double-stranded DNA, low complement) and despite standard therapy, as per its marketing authorisation. According to NICE, while clinical trial evidence suggests that after a year of treatment Benlysta plus standard therapy reduces disease activity more than standard therapy alone, “the results are uncertain because the trials were short”. Also, it noted that the long-term benefit of Benlysta compared with standard therapy or rituximab is unknown, as long-term extension studies did not have comparator arms. Cost-effectiveness estimates are also uncertain, and are most likely ...
- Source: drugdu
- 326
- June 4, 2021
GSK
EC clears GSK’s Benlysta for lupus nephritis

The European Commission approved expanded use of GlaxoSmithKline’s intravenous and subcutaneous Benlysta (belimumab) in combination with background immunosuppressive therapies for adults with active lupus nephritis (LN). The drug is already on the market to treat systemic lupus erythematosus (SLE); this latest approval now provides physicians and patients in Europe with the first and only biologic treatment specifically designed to work in lupus and LN. “Active lupus nephritis, which causes inflammation in the kidneys, is one of the most serious consequences of systemic lupus erythematosus and occurs in more than 1 million patients worldwide,” noted Dr Hal Barron, GSK’s chief scientific officer and president R&D. “Benlysta is the first biologic approved to treat lupus and lupus nephritis, representing a significant new treatment option for patients and physicians across Europe dealing with this complex autoimmune disease.” The drug’s marketing submission was based on data from the BLISS-LN (Efficacy and Safety of Belimumab ...
- Source: drugdu
- 498
- May 10, 2021
GSK

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