Rates of vaccination in the U.S. have dropped in recent years, with the COVID-19 pandemic hitting uptake. GSK, with a new vaccine to market, is looking to help turn this around.GSK is running a new “COiMMUNITY Initiative” that will add new funds, deeper data transparency and collaboration for all vaccine uptake across the country. On the money side, GSK said in a press release that it is “committing” up to $1 million in grant funding to support groups focused on adult immunization and health equity. On the data and collaboration side, GSK said it will continue to make adult vaccination claims data available through Vaccine Track platform, which publishes on a quarterly basis. The company also said it will “enhance the platform’s capabilities.” GSK is also looking to open the platform up to public and private stakeholders “to potentially integrate and host additional data and viewpoints on adult vaccination trends,” ...
About a month after GSK won the world’s first approval for a respiratory syncytial virus (RSV) vaccine, rival Pfizer has followed suit. Late Wednesday, the New York drugmaker said its Abrysvo won FDA approval to prevent against lower respiratory tract disease caused by RSV in adults 60 and older. Both companies are looking to launch their offerings ahead of the upcoming RSV season, which typically starts in the late fall. Before the launch, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) will meet later this month to discuss recommendations for the newly approved RSV shots. Pfizer expects to make the vaccine available in the third quarter, should ACIP members put their support behind the vaccine. The FDA approved Abrysvo based on data from a phase 3 trial called RENOIR, which enrolled about 37,000 participants. In the study, the vaccine achieved 66.7% protection against RSV-associated lower ...
As GSK’s July court date nears for a key Zantac trial in California, the company can wipe its hands of at least one Canadian class action suit. The company said in a Friday statement that it “welcomes the decision” of the British Columbia Supreme Court to dismiss a proposed class action suit on behalf of Canadian Zantac users. A Vancouver man filed the lawsuit in 2020, alleging that his use of the heartburn med from 2018 to 2019 caused him to develop cancer. His complaint named more than a dozen companies as defendants, including Sandoz Canada and GSK. But the court dismissed the case due to “the uncontroverted evidence that neither ranitidine nor NDMA are reliably associated with increased cancer risk,” GSK said in its statement. Zantac is ranitidine’s brand name and much of the Zantac cases revolve around reports of N-nitrosodimethylamine (NDMA) contamination in the products. Health Canada started investigating the potential impurity in ...
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 ...
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 ...
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 ...
[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 ...
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 ...
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 ...
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
Go to Page Go
your submission has already been received.
OK
Please enter a valid Email address!
Submit
The most relevant industry news & insight will be sent to you every two weeks.