Search Results for “GSK ” – Page 4 – media

GSK Returns Shigella Vaccine Candidate to LimmaTech as Drug-Resistant Cases Rise

Pictured: GSK headquarters office in Poland/iStock, Wirestock GSK has licensed out its Shigella vaccine candidate to LimmaTech Biologics, giving the Swiss biotech rights to further develop and eventually commercialize the quadrivalent bioconjugate investigational vaccine, the companies announced Thursday. LimmaTech is aiming to complete the Phase I/II clinical trial for this quadrivalent candidate and post data from this study within the year. The investigational Shigella shot joined GSK’s portfolio in 2015, when the pharma giant bought Swiss vaccine specialist GlycoVaxyn for $190 million. Aside from shigellosis, the disease caused by Shigella bacteria, GlycoVaxyn also handed over early-stage vaccines for pneumonia and infectious conditions caused by Pseudomonas bacteria and Staphylococcus aureus. LimmaTech spun out of this acquisition and started its operations in August of the same year. The clinical-stage biotech is focused on engineering complex carbohydrate molecules to come up with next-generation vaccine candidates. It has since signed partnerships with GSK for its Shigella and Klebsiella development programs. ...
- Source: drugdu
- 106
- July 24, 2023
GSK-Funded Report on Adult Vaccination Rates Finds Major Global Declines in Recent Years

While vaccines for COVID-19 have certainly enjoyed the spotlight in recent years, rates of uptake for other shots have sharply declined.That’s the finding of a new analysis funded by GSK in collaboration with the IQVIA Institute for Human Data Science and the Global Coalition on Aging (GCOA). All told, about 100 million fewer doses than anticipated of some adult vaccines, other than those targeting COVID-19, were administered between 2021 and 2022, the team found. To reach this number, the group weighed vaccine use in the last two years versus trends in global vaccine adoption from 2013 to 2020. In fact, just 16.2 doses of some vaccines were doled out globally per 100 adults in 2022. Meanwhile, COVID-19 vaccines saw overwhelming success with 132 doses delivered for every 100 adults in the same year, according to the report. “While significant strides in vaccine development have delivered vaccines to ...
- Source: drugdu
- 205
- July 21, 2023
GSK’s Jemperli Made Available to Endometrial Cancer Patients via UK’s Early Access Scheme

GSK has announced that eligible endometrial cancer patients in the UK will be granted early access to its anti-PD-1 therapy Jemperli (dostarlimab) in combination with platinum-containing chemotherapy via the Early Access to Medicines Scheme (EAMS). The EAMS aims to give patients with life threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorisation when there is a clear unmet medical need. The combination has been specifically indicated to treat adults with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer who are candidates for systemic therapy. Endometrial cancer is the most common gynaecological cancer in the UK, with approximately 10,000 new cases reported each year. While it often has a better prognosis than other womb cancers if diagnosed early, patients with advanced or recurrent disease face limited treatment options and a poor prognosis. The positive scientific opinion from the Medicines and ...
- Source: drugdu
- 116
- July 13, 2023
GSK’s ViiV explores novel pathway to bring long-acting HIV med Cabenuva to tough-to-treat patients

GSK’s Cabenuva made history in 2020 as the world’s first complete, long-acting HIV regimen. But the injectable drug is approved in various countries only as a switch therapy for patients who already have undetectable HIV levels in the blood. Trying to reach tough-to-treat patients who have difficulty controlling the virus with existing daily oral therapies, GSK’s ViiV Healthcare is getting creative. To seek an approval for Cabenuva in patients who aren’t virologically suppressed while on oral drugs, GSK’s ViiV is exploring running a clinical trial using a historical control group. This would replace the standard practice of randomizing some patients in the study to receive standard-of-care oral meds, ViiV’s R&D head Kimberly Smith, M.D., said during a recent interview. The FDA in February unveiled draft guidance laying out the considerations for the use of external control groups in clinical trials to prove a drug’s safety and efficacy. The gist is, ...
- Source: drugdu
- 102
- July 9, 2023
CDC recommends RSV vaccines from Pfizer, GSK for adults 60 and older

The Centers for Disease Control and Prevention on Thursday recommended that adults ages 60 and above receive a single dose of RSV vaccines from Pfizer and GSK after consulting their doctors. Outgoing CDC Director Rochelle Walensky signed off on the recommendation, which an advisory panel of outside experts made last week. That endorsement says seniors should work with their health-care providers to decide if taking a shot is right for them. The CDC said the shots are expected to be available to the public this fall, when respiratory syncytial virus – along with Covid and the flu – typically begins to spread at higher levels. “These vaccines provide an opportunity to help protect older adults against severe RSV illness at a time when multiple respiratory infections are likely to circulate,” the CDC said in a statement. The virus is a common respiratory infection that usually causes mild, cold-like symptoms, but ...
- Source: drugdu
- 109
- July 2, 2023
GSK Awaits Approval for Myelofibrosis Hopeful

The FDA’s final action date this week is for GSK’s investigational drug, momelotinib, which the company is proposing to treat myelofibrosis patients with anemia. The decision is set to be released by June 16. According to GSK, momelotinib works through a differentiated mechanism of action that involves the inhibition of three signaling pathways: the JAK1 and JAK2 cascades, as well as the activin receptor type I (ACVR1) pathway. By disrupting JAK1 and JAK2 signaling, momelotinib induces improvements in patient constitution and symptoms of splenomegaly. Meanwhile, its ACVR1 activity could decrease levels of hepcidin, which contribute to anemia in myelofibrosis. Data from the pivotal Phase III MOMENTUM trial supported momelotinib’s FDA bid. In December 2022, GSK reported 48-week results from MOMENTUM at the 64th American Society of Hematology (ASH) Annual Meeting. Momelotinib achieved its primary efficacy endpoint of an at-least 50% reduction in Total Symptom Score after 24 weeks. GSK’s myelofibrosis ...
- Source: drugdu
- 107
- June 14, 2023
GSK’s RSV vaccine approved by EC for older adults

GSK’s respiratory syncytial virus (RSV) vaccine has been approved by the European Commission (EC) for the prevention of RSV-caused lower respiratory tract disease (LRTD) in adults aged 60 years and older. The EC’s decision, which follows a recent recommendation from the European Medicines Agency’s human medicines committee, makes Arexvy the first RSV vaccine for older adults to be granted European Marketing Authorisation. 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 270,000 hospitalisations and approximately 20,000 in-hospital deaths each year in Europe. GSK’s EU application was supported by positive results from its phase ...
- Source: drugdu
- 114
- June 9, 2023
After nabbing historic RSV shot approval, GSK looks to boost US vaccination rates

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,” ...
- Source: drugdu
- 127
- June 6, 2023
Look out, GSK. Pfizer has its adult RSV vaccine approval and is raring to launch

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 ...
- Source: drugdu
- 125
- June 5, 2023
Ahead of high-stakes California trial, GSK notches Zantac win in Canada

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 ...
- Source: drugdu
- 118
- May 16, 2023

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