Roche’s Genentech unit has won FDA approval for Susvimo, an implant for eyesight-robbing disease wet age-related macular degeneration (AMD) that gives patients an alternative to regular injections into the eye. Susvimo has the same active ingredient as Roche’s big-selling therapy…
Lilly files Alzheimer’s drug donanemab as Cortexyme rival fails trial
Eli Lilly has followed through on its plan to file for approval of its Alzheimer’s disease candidate donanemab, and is planning to take on Biogen and Eisai with a head-to-head trial against their recently-approved Aduhelm drug. Lilly has also picked…
Ocugen Hopes to Launch Phase III Trial of Covaxin in U.S.
Malvern, Pa.-based Ocugen has submitted an Investigational New Drug (IND) to the U.S. Food and Drug Administration (FDA) to run a Phase III trial of India’s BBV152 (Covaxin), a vaccine against COVID-19. Part of the trial’s goal is to determine if the vaccine’s…
UCB licenses AI tech for spinal fracture detection to ImageBiopsy
An artificial intelligence-based tool for identifying hard-to-detect spinal fractures, developed by Belgian drugmaker UCB, has been licensed out to ImageBiopsy Lab for further development. The digital health tool, known as BoneBot, applies machine learning to X-rays to detect ‘silent’ or…
FDA clears AI-powered digital test for early dementia
The FDA has approved an artificial intelligence-based test for early detection of dementia that can be carried out on an iPad in five minutes. The CognICA Integrated Cognitive Assessment (ICA) test developed by London, UK-based company Cognetivity Neurosciences has been…
Asia-Pacific has seen the largest growth in cardiovascular trials over the past decade
We’ve analysed 10 years’ worth of clinical trials data from GlobalData to pick out key geographic trends. The Asia-Pacific region has seen a 38% increase in the number of cardiovascular trials taking place over the past decade, the largest increase…
Innovent’s sintilimab meets primary goal of Phase III lung cancer trial
The safety profile in the trial was consistent with already observed data from trials of sintilimab and Byvasda. Innovent Biologics has reported that its sintilimab met the prespecified primary goal in the ORIENT-31 clinical trial in epidermal growth factor receptor…
Valneva’s Covid-19 vaccine meets co-primary goals in Phase III trial
Valneva has reported that its inactivated, adjuvanted Covid-19 vaccine candidate, VLA2001, met the co-primary goals of the Phase III Cov-Compare clinical trial in adolescent and adult subjects. VLA2001 comprises inactivated whole SARS-CoV-2 virus particles with high S-protein density, along with…
SOM’s AI-discovered drug shows promise in Huntington’s disease
A drug originally developed for high blood pressure could find a new use in the treatment of Huntington’s disease, thanks to an artificial intelligence-based drug discovery programme at Spain’s SOM Biotech. SOM3355 (bevantolol hydrochloride) hit its objectives in a phase…
Pfizer agrees $630m deal to harness Voyager’s gene therapy tech
Voyager Therapeutics has just landed a new gene therapy alliance with Pfizer that could go some way towards easing the pain of losing three other partners in the space of a couple of years. Pfizer is paying Voyager $30 million…
