News and Trends 3 Jan 2023 Sensorion announces first patient enrolled in cisplatin-induced ototoxicity trial Sensorion has announced that the first patient has been enrolled in its phase 2a proof of concept clinical trial of SENS-401 (Arazasetron) in patients suffering from cisplatin-induced ototoxicity. Cisplatin and other platinum-based compounds are essential chemotherapeutic agents for many cancers. A serious side effect of these therapies is ototoxicity, or permanent and irreversible hearing loss, […] January 3, 2023 - 3 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 22 Dec 2022 First CAR-T technology trial for patients with T-cell leukemia subtype authorized The Spanish Agency of Medicines and Medical Products (AEMPS) has approved the CARxALL clinical trial led by the company OneChain Immunotherapeutics (OCI). It will be the world’s first trial with CAR-T technology for patients with a subtype of T-cell leukemia. The CARxALL trial will evaluate, for the first time, the CAR-T CD1a (OC-1) therapy. This […] December 22, 2022 - 4 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 22 Dec 2022 Positive Dupixent eosinophilic esophagitis phase 3 results The New England Journal of Medicine has published results from a positive phase 3 trial showing adults and adolescents treated with Dupixent (dupilumab) 300 mg weekly experienced significant improvements in signs and symptoms of eosinophilic esophagitis (EoE), which were sustained for up to one year. EoE is a chronic, progressive inflammatory disease that damages the […] December 22, 2022 - 4 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 21 Dec 2022 Watch: Mauritius – clinical trials and emerging biotech hub The Economic Development Board (EDB) in Mauritius commenced its operations as a statutory body in 2018 following the merger between the Board of Investment, Enterprise Mauritius and the Financial Services Promotion Agency. The overarching objective of the EDB is to ensure greater coherence and effectiveness in implementing policies and draw the vision for the economic […] December 21, 2022 - 2 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 21 Dec 2022 Pfizer diabetes and obesity study triggers Sosei Heptares windfall Sosei Group Corporation has been notified by Pfizer that the first subject in a phase 2 clinical trial has been dosed with Pfizer’s candidate PF-07081532. This triggers a $10 million payment to Sosei Heptares. PF-07081532 is a once-daily, next-generation oral small molecule GLP-1 receptor agonist in development for the treatment of type 2 diabetes and obesity. […] December 21, 2022 - 3 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 20 Dec 2022 Verona Pharma drug meets COPD phase 3 trial endpoints Verona Pharma plc has announced positive results of its phase 3 ENHANCE-1 trial evaluating nebulized ensifentrine for the maintenance treatment of chronic obstructive pulmonary disease (COPD). The ENHANCE-1 trial successfully met its primary and key secondary endpoints demonstrating significant improvements in lung function, symptoms and quality of life measures. In addition, ensifentrine substantially reduced the […] December 20, 2022 - 2 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 19 Dec 2022 UroGen completes bladder cancer phase 3 trial enrollment UroGen Pharma Ltd. says its phase 3 ENVISION study of investigational agent UGN-102 (mitomycin) for intravesical solution in development for the treatment of LG-IR-NMIBC is fully enrolled. The study targeted enrollment of 220 patients across 90 sites and, assuming positive findings, UroGen anticipates submitting a New Drug Application (NDA) for UGN-102 in 2024. “Completing enrollment […] December 19, 2022 - 3 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 19 Dec 2022 SoftOx receives chronic wound study report Norwegian company SoftOx Solutions AS says it has received the final report and analysis of its phase 1 study evaluating the safety and tolerability of SoftOx Biofilm Eradicator (SBE-01). SBE-01 is SoftOx’s antimicrobial solution for the treatment of chronic wounds. The study is a first-in-human investigation of the safety, tolerability, and antimicrobial efficacy of single […] December 19, 2022 - 2 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 16 Dec 2022 Astellas gastric cancer drug meets phase 3 primary endpoint Astellas Pharma Inc. has announced positive topline results from the phase 3 GLOW clinical trial evaluating the efficacy and safety of zolbetuximab in combination with CAPOX (a combination chemotherapy regimen that includes capecitabine and oxaliplatin). Zolbetuximab is an investigational first-in-class claudin-18.2 (CLDN18.2) targeted monoclonal antibody, for the first-line treatment of patients with CLDN18.2-positive, HER2-negative, locally […] December 16, 2022 - 3 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 14 Dec 2022 NMD Pharma cleared for spinal muscular atrophy trial NMD Pharma A/S has received clearance for its investigational new drug (IND) application from the US Food and Drug Administration (FDA) to advance NMD670 into a phase II clinical study in patients of spinal muscular atrophy (SMA) type 3. NMD Pharma is a Danish clinical stage biotech company developing first-in-class, small molecule ClC-1 inhibitors for […] December 14, 2022 - 2 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 14 Dec 2022 ImaginAb launches trial to study neoadjuvant immunotherapy ImaginAb Inc., in collaboration with Memorial Sloan Kettering Cancer Center (MSK) and Melanoma Research Alliance (MRA), has launched an investigator-initiated phase II trial. It will explore the efficacy and safety of neoadjuvant immune checkpoint inhibitor treatment of stage III surgically resectable melanoma through use of CD8 ImmunoPET. ImaginAb is a global biotechnology company focused on […] December 14, 2022 - 2 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 14 Dec 2022 Asieris doses first patient in bladder cancer diagnostic trial Asieris Pharmaceuticals has announced that Hexvix, a drug used for bladder cancer diagnosis, completed dosing for the first patient in its real-world clinical study at Hainan General Hospital Lecheng Branch. Hexvix has been approved in the U.S. and many European countries. The combined use of Hexvix and blue light cystoscopy (BLC) for the management of […] December 14, 2022 - 2 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email