The Technical Advisory Group of WHO, which met today, has recommended the Emergency Use Listing status for Bharat Biotech’s Covaxin – a decision that will ease international travel and the export of the indigenous vaccine. The World Health Organisation’s panel…
Inovio and AstraZeneca Terminate Six-Year-Old DNA Cancer Vaccine Program
Shares of Inovio are down about 2% in premarket trading after reports surfaced of the cancellation of a six-year-old development agreement for a DNA cancer vaccine collaboration related to human papillomavirus with AstraZeneca. In a U.S. Securities and Exchange filing, Inovio…
FDA clears Roche’s Susvimo implant for eye disease wet AMD
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…
