Touting what’s been so far the “cleanest safety profile that’s been presented with genetic medicine in the eye,” deemed “a game changer for this field,” 4D Molecular Therapeutics Inc. CEO David Kirn said phase III planning will begin in later this year to test gene therapy 4D-150 in wet age-related macular degeneration (AMD).
Positive phase III results from Surmount-2 of Eli Lilly and Co.’s Mounjaro (tirzepatide) showed overweight and obese type 2 diabetes patients receiving the highest dose lost up to 34.4 pounds, with the majority achieving at least a 5% decrease in overall body weight. The results will help the Indianapolis-based company complete its rolling supplemental NDA with the U.S. FDA targeting an approval for obese and overweight adults with weight-related co-morbidities.
The Memed BV test, developed by Memed Diagnostics Ltd. to distinguish between bacterial and viral infections, offers an accurate diagnosis of the infection in children, and reduces the unnecessary prescription of antibiotics by physicians, according to a study published in the journal, PLOS One.
The 10-year update to Medtronic plc’s ENGAGE registry for its Endurant abdominal aortic aneurysm (AAA) stent graft system demonstrated high degrees of protection from aneurysm and sac regression in a real-world setting. The results were presented at the 2023 Charing Cross Symposium in London on April 26.
The long-anticipated top-line phase IIa study results for Morphic Therapeutic Inc.’s oral alpha 4 beta 7 integrin inhibitor, MORF-057, have surpassed even the company’s own expectations, with a significant decline in disease activity seen in moderate to severe ulcerative colitis (UC) patients combined with a safety profile consistent with phase I findings.
Shanghai Junshi Biosciences Co. Ltd.’s anti-PD-1 monoclonal antibody toripalimab showed positive interim event-free survival (EFS) results in a phase III study to treat patients with resectable non-small-cell lung cancer (NSCLC). This is the world’s first phase III trial that shows perioperative treatment with an anti-PD-1 monoclonal antibody significantly extends EFS of patients with resectable NSCLC, according to Shanghai-based Junshi Biosciences.
The data are early and from only seven evaluable patients, but results from In8bio Inc.’s phase I study of gamma-delta T-cell therapy INB-100 in leukemia patients who have undergone haploidentical hematopoietic stem cell transplant, presented at the European Society for Blood and Marrow Transplantation meeting, were compelling enough to drive the company’s shares (NASDAQ:INAB) up 183% April 24.
Shanghai Junshi Biosciences Co. Ltd.’s anti-PD-1 monoclonal antibody toripalimab showed positive interim event-free survival (EFS) results in a phase III study to treat patients with resectable non-small-cell lung cancer (NSCLC). This is the world’s first phase III trial that shows perioperative treatment with an anti-PD-1 monoclonal antibody significantly extends EFS of patients with resectable NSCLC, according to Shanghai-based Junshi Biosciences.
Moderna Inc.’s mixed results in mid-February from a trial with its mRNA influenza vaccine served to emphasize the need for a more comprehensive preventer of the still problematic-for-many seasonal bug – a space where Vir Biotechnology Inc. has been busy and is slated to report closely watched phase II data from the study called Peninsula in late spring or early summer of this year.
The U.S. FDA’s green light April 17 for Abbvie Inc. to expand the label of Qulipta (atogepant) – the first and only oral calcitonin gene-related peptide (CGRP) receptor antagonist for migraine, with language that includes prevention of such headaches chronically in adults – provided a welcome addition to the arsenal, but sufferers are still waiting for an improved remedy. Vaxxinity Inc. just might have it. And with a vaccine, no less.