December 3, 2023

Positive results from DREAMM-7 head-to-head phase III trial for Blenrep (belantamab mafodotin) in relapsed/refractory multiple myeloma – GSK

GSK plc announced positive headline results from a planned interim efficacy analysis of the DREAMM-7 head-to-head phase III trial evaluating belantamab mafodotin as a second-line treatment for relapsed or refractory multiple myeloma The trial met its primary endpoint of progression-free survival (PFS) and showed that belantamab mafodotin when combined with bortezomib plus dexamethasone (BorDex) significantly extended the time to disease […]

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August 31, 2023

Results of phase IV trial (ZOSTER-076) of Shingrix shows efficacy and safety in Herpes Zoster – GSK

GSK announced positive results from the first-ever efficacy trial of Shingrix (Recombinant Zoster Vaccine or RZV) in China. These results come from the post-license phase IV trial (ZOSTER-076), which evaluated the efficacy and safety of RZV in preventing shingles in adults aged 50 and over. The trial included almost 6,000 participants randomised 1:1 to the RZV or placebo group and […]

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August 3, 2023

Jemperli + chemotherapy approved by the FDA as the first new frontline treatment option in decades for dMMR/MSI-H primary advanced or recurrent endometrial cancer – GSK

GSK plc announced that the FDA has approved Jemperli (dostarlimab) in combination with carboplatin and paclitaxel, followed by Jemperli as a single agent for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR), as determined by an FDA-approved test, or microsatellite instability-high (MSI-H). The supplemental Biologics License Application (sBLA) supporting this […]

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July 19, 2023

MHRA (UK) approves Arexvy for prevention of lower respiratory tract disease caused by respiratory syncytial virus in adults 60 years of age and older – GSK

GSK plc announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has authorised Arexvy (respiratory syncytial virus vaccine, adjuvanted) for active immunisation for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults 60 years of age and older. This is the first time an RSV vaccine for older adults has been authorised […]

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July 7, 2023

CHMP positive for Jesduvroq to treat symptomatic anemia in adults with chronic kidney disease who are on dialysis – GSK

Jesduvroq (daprodustat) from GSK received a positive opinion from the CHMP for the treatment of adult patients for for the treatment of symptomatic anaemia in adults with chronic kidney disease who are on chronic dialysis. The benefit of Jesduvroq is its ability to correct haemoglobin levels in dialysis-dependent patients, with effects comparable to those seen with erythropoiesis-stimulating agents. The most […]

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June 11, 2023

EU approves Arexvy for respiratory syncytial virus – GSK

GSK announced that the European Commission has authorised Arexvy (respiratory syncytial virus vaccine, adjuvanted) for active immunisation for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults 60 years of age and older. This is the first time an RSV vaccine for older adults has been granted European Marketing Authorisation. The first launches […]

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July 7, 2022

Positive results from phase III PRIME study of Zejula at Society of Gynecologic Oncology Meeting – Zai Lab + GSK

Zai Lab Limited presented data from the Phase III PRIME study of Zejula (niraparib) as maintenance therapy at the Society of Gynecologic Oncology annual meeting . Zejula demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) with a tolerable safety profile in Chinese patients with newly diagnosed advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer (collectively […]

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July 28, 2021

GSK announces positive headline results from five phase III studies of daprodustat for patients with anaemia due to chronic kidney disease

GlaxoSmithKline plc announced positive headline results from five studies of the Phase III ASCEND programme, evaluating the efficacy and safety profile of daprodustat, an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for patients with anaemia due to chronic kidney disease (CKD). The ASCEND programme showed that daprodustat met its primary efficacy endpoint in each study, demonstrating an improvement in […]

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May 13, 2021

European Commission approves Benlysta for adult patients with active lupus nephritis – GSK

Copyright © ICR (UK) Limited t/a International Medical Information (IMI). Registered in the UK Company no. 05894351 medicalupdateonline.com is brought to you by International Medical Information. For more details, visit http://www.medicalimi.com Disclaimer: All information on this site has been collated by healthcare professionals from around the globe. Where every possible step has been taken to ensure its accuracy, MedicalUpdateOnline cannot […]

admin Health 0 27 sec read
May 1, 2021

FDA grants accelerated approval for Jemperli in endometrial cancer – GSK

Copyright © ICR (UK) Limited t/a International Medical Information (IMI). Registered in the UK Company no. 05894351 medicalupdateonline.com is brought to you by International Medical Information. For more details, visit http://www.medicalimi.com Disclaimer: All information on this site has been collated by healthcare professionals from around the globe. Where every possible step has been taken to ensure its accuracy, MedicalUpdateOnline cannot […]

admin Health 0 27 sec read

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