The US Food and Drug Administration (FDA) has approved AstraZeneca’s osimertinib (Tagrisso) as a treatment for locally advanced or metastatic non-small cell lung cancer (la/mNSCLC). It is approved in combination with platinum-based chemotherapy for patients with la/mNSCLC whose tumours have EGFR exon 19 deletions or exon… Read More
UCB has revealed new data demonstrating a 55% improvement in adults with moderate to severe hidradenitis suppurativa (HS) treated with monoclonal antibody bimekizumab. The data were presented at the 13th Conference of the European Hidradenitis Suppurativa Foundation (EHSF) in Lyon, France (7-9 February). Emmanuel… Read More
AstraZeneca and Ionis’ Wainua (eplontersen) has been approved in the US for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults (hATTR-PN or ATTRv-PN). The approval by the US Food and Drug Administration (FDA) was based on the positive 35-week interim analysis from the… Read More
Takeda’s Livtencity (maribavir) has been approved in China for the treatment of adult patients with post-hematopoietic stem cell transplant (HSCT) or solid organ transplant (SOT) cytomegalovirus (CMV) infection/disease. It has been licensed by the National Medical Products Administration (NMPA) in cases where the infection is resistant… Read More
The US Food and Drug Administration (FDA) has approved antibody-drug conjugate (ADC) enfortumab vedotin-ejfv (Padcev) in combination with pembrolizumab (Keytruda) for patients with locally advanced or metastatic urothelial cancer (la/mUC). The approval is based on clinical data which found that Padcev plus pembrolizumab nearly doubled median… Read More
The first patient has been dosed in a Phase III study evaluating a paediatric granulated formulation of leniolisib in children with activated phosphoinositide 3-kinase delta syndrome (APDS). Pharming’s investigational drug leniolisib is an oral, selective phosphoinositide 3-kinase delta (PI3Kδ) inhibitor. At sites in the… Read More
New trial evidence has shown that Kite’s CAR-T cell therapy Yescarta (axicabtagene ciloleucel: axi-cel) reduces the risk of death by 27.4% in patients with relapsed or refractory large B-cell lymphoma (R/R LBCL), corresponding to a 38% improvement in overall survival (OS). It is the only treatment… Read More
Semaglutide 2.4mg (Wegovy), a drug approved for weight loss, can reduce the risk of major adverse cardiovascular events (MACE) by 20%, according to new data released by Novo Nordisk. SELECT is a Phase III cardiovascular outcomes trial investigating the effects of once-weekly semaglutide 2.4mg in adults… Read More
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has revealed plans to reduce the time taken to approve the lowest-risk clinical trials by more than 50%. According to the plans, initial applications for the lowest-risk Phase III and IV trials will be processed by the… Read More
The US Food and Drug Administration (FDA) has granted clearance to Transcenta to proceed with its TranStar 301 global Phase III pivotal trial of Osemitamab (TST001) for gastric cancer. The trial will investigate the drug in combination with Nivolumab and chemotherapy as a first-line treatment in… Read More
In the Phase III innovaTV 301 trial in recurrent or metastatic cervical cancer patients with disease progression on or after front-line therapy, Tivdak (tisotumab vedotin-tftv), compared with chemotherapy alone, met its primary endpoint of overall survival (OS). An independent data monitoring committee determined that OS crossed… Read More
The US Food and Drug Administration (FDA) has expanded the use of Bristol Myers Squibb’s Reblozyl (luspatercept-aamt) to include first-line treatment of anaemia in adults with lower-risk myelodysplastic syndromes (MDS). The approval is for the treatment of anaemia without previous erythropoiesis stimulating agent use (ESA-naïve) in adult… Read More
AstraZeneca’s Forxiga (dapagliflozin) has been approved in China to reduce the risk of cardiovascular death, hospitalisation for heart failure (HF), or urgent HF visits in adults with symptomatic chronic HF. The drug was previously approved in China but was limited to HF patients with reduced ejection… Read More
Ipsen’s Sohonos (palovarotene) has become the first drug approved for patients with fibrodysplasia ossificans progressiva (FOP) in the US, following the granting of a marketing authorisation by the Food and Drug Administration (FDA). The capsules are approved for reduction in the volume of new heterotopic ossification… Read More
Janssen’s Akeega (niraparib and abiraterone acetate) is now available in the US for adult patients with deleterious or suspected deleterious BRCA-positive metastatic castration-resistant prostate cancer (mCRPC) following FDA approval. It is the first dual action tablet combining a PARP inhibitor with abiraterone acetate, given with prednisone,… Read More
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation to Eli Lilly’s mirikizumab for moderately to severely active ulcerative colitis. The drug is approved in adult patients who have had an inadequate response with, lost response to, or were intolerant to either… Read More
