All articles tagged with #gsk
GSK's Exdensur (depemokimab) has been approved by the US FDA as a twice-yearly treatment for severe eosinophilic asthma in patients aged 12 and older, based on phase III trial data showing significant reduction in exacerbations and hospitalizations, with a favorable safety profile.
GSK's blood cancer drug Blenrep received a narrower FDA approval than expected, leading to a more than 5% drop in GSK stock; despite showing some survival benefits in studies, concerns over ocular side effects and a panel's risk assessment limited its approval prospects.
The US FDA has approved GSK's Blenrep in combination with bortezomib and dexamethasone for treating relapsed/refractory multiple myeloma in patients who have received at least two prior therapies, based on positive results from the DREAMM-7 trial showing significant survival benefits. Blenrep is notable for its community accessibility and ongoing development in earlier treatment lines.
The FDA approved GSK's blood cancer drug Blenrep for use in one combination regimen but rejected another, marking a complex decision in the drug's regulatory history.
GSK's stock rose after CEO Emma Walmsley announced her departure, with Luke Miels set to succeed her. Walmsley's leadership saw strategic shifts including the Haleon demerger and a focus on R&D, leading to a 16% stock increase this year. The company aims for a smooth leadership transition as it prepares for future growth.
GSK's CEO Emma Walmsley will step down at the end of the year and be replaced by insider Luke Miels, as the company aims to accelerate its pipeline and navigate a challenging global environment. The leadership change has been well received by investors, with Miels expected to focus on delivering GSK's growth targets amid geopolitical and market uncertainties.
GSK's CEO Emma Walmsley will step down in December after nine years, with Luke Miels, the company's chief commercial officer, named as her successor to lead the company into its next growth phase and meet future sales targets amid a challenging economic environment.
Emma Walmsley, the first woman to lead a major pharmaceutical company, will step down as CEO of GSK on December 31 after over eight years, with Luke Miels set to succeed her. Despite strategic successes like spinning off Haleon, GSK's share performance has been underwhelming, with only modest growth and a significant decline since Walmsley's appointment.
The FDA has reapproved GSK's leucovorin for treating cerebral folate deficiency, a condition affecting many children with autism, which may lead to increased use of leucovorin-based supplements despite limited evidence of effectiveness for autism treatment.
The FDA has reapproved GSK's leucovorin, a drug previously discontinued over 25 years ago, as part of a broader initiative by the Trump administration to explore potential autism treatments, with RFK Jr. promoting its use for autism.
The FDA approved leucovorin, a form of folic acid, which was suggested by President Trump as a potential treatment for autism symptoms, based on data indicating it may improve symptoms related to cerebral folate deficiency, a condition associated with neuropsychiatric symptoms including autistic features.
GSK announced a $30 billion investment in U.S. research, development, and manufacturing over five years, including $1.2 billion for advanced manufacturing and digital tech, amid President Trump's UK visit, reflecting increased U.S. pharma investments.
A review presented at the European Society of Cardiology suggests that the shingles vaccine not only prevents shingles but may also reduce the risk of heart attack and stroke, with vaccinated individuals showing an 18% lower risk of cardiovascular events, though more research is needed to confirm causality.
Jiangsu Hengrui Pharmaceuticals shares surged after GSK agreed to pay up to $12 billion in a licensing deal for multiple drug candidates, including a potential COPD treatment, marking the largest deal for Chinese drug innovators and highlighting the growing international recognition of Chinese pharmaceutical innovations.
GSK and Hengrui Pharma have entered into agreements to develop up to 12 innovative medicines, including a potential best-in-class PDE3/4 inhibitor for COPD, with GSK paying $500 million upfront and the potential for up to $12 billion in milestone payments, aiming to expand their pipelines in respiratory, immunology, inflammation, and oncology.