Iovance Biotherapeutics is facing a three-month delay in the review of its lifileucel cell therapy for melanoma in the US, held up by “insufficient resources” at the FDA. The new data has been extended from 25th November to 24th February next…
Further clinical success for Anteris Technologies’ biomimetic heart valve
Anteris Technologies has revealed that a successful procedure of its DurAVR transcatheter aortic valve (THV) took place in a Canadian study as the company continues to build up positive clinical evidence for the device. Implanted in patients as part of…
QiLu’s ALK inhibitor meets Phase III primary endpoint in NSCLC
China-based QiLu Pharmaceutical has announced positive data from a Phase III trial investigating iruplinalkib in patients with non-small cell lung cancer (NSCLC). The data analysis showed that the primary endpoint of progression-free survival (PFS) met the pre-defined criteria. Additionally, PFS…
Verily and OneOncology establish partnership for clinical trials
Alphabet precision health technology company Verily and OneOncology have announced a strategic collaboration for clinical trials. Under the partnership, community OneOncology Research Network sites will get access to new tools for expediting trials and improving their cancer care delivery. Verily’s…
Ocugen plans two Phase I/II trials in macular disease
Phase I/II trials for Ocugen’s gene therapies, OCU410 and OCU410ST, are planned for initiation by the end of 2023 in geographic atrophy and Stargardt disease. The plans follow the US Food and Drug Administration’s (FDA) approval of the Investigational New…
BioMarin’s Roctavian becomes first FDA-approved gene therapy for severe haemophilia A
The FDA has approved BioMarin’s Roctavian (valoctogene roxaparvovec) for adults with severe haemophilia A. Currently, around half of the patients who have the most severe form of haemophilia A undergo intravenous Factor VIII (FVIII) infusions two to three times per…
FDA grants Priority Review of Astellas’ zolbetuximab BLA
Astellas Pharma Inc has announced that the US Food and Drug Administration (FDA) has accepted and granted Priority Review of its zolbetuximab Biologics License Application (BLA). If approved, the first-in-class investigational Claudin 18.2 (CLDN18.2)-targeted monoclonal antibody would be the first…
AI-based heart disease tool wins Future NHS Award
A digital tool developed by researchers in the NHS that is being used to speed up the diagnosis of heart disease has won this year’s Future NHS Award, which recognises outstanding contributions from the health service workforce. The artificial intelligence-powered…
FDA approves first progression-slowing Alzheimer’s drug
Yesterday the US Food and Drug Administration granted full approval to Eisai and Biogen’s Leqembi (lecanemab-irmb), making it the first approved Alzheimer’s treatment clinically shown to slow disease progression and cognitive and functional decline. Though these benefits are modest –…
Boehringer and Zealand step into obesity market with positive Phase II data
Boehringer and Zealand released Phase II data with the investigational drug survodutide, while Novo Nordisk presented new Ozempic data. At the American Diabetes Association’s 83rd Scientific Sessions, Boehringer Ingelheim and Novo Nordisk took another step in the obesity arena with…
