The companies said in first-quarter earnings calls that they want to restructure R&D, cut costs and shift away from high-risk drug development to focus areas.
Moderna Inc. said on Tuesday its closely watched flu vaccine did not meet the criteria for early success in a late-stage trial, sending its shares down nearly 5% premarket.
This exclusive licence agreement gives GSK rights to commercialize Brexafemme for vulvovaginal candidiasis and recurrent VVC while continuing to develop ibrexafungerp, which is in phase III clinical trials for the potential treatment of invasive candidiasis (IC), a life-threatening fungal infection.
Elon Musk’s brain implant company Neuralink has approached one of the biggest U.S. neurosurgery centers as a potential clinical trials partner as it prepares to test its devices on humans once regulators allow for it, according to six people familiar with the matter.
The accelerated approval pathway is commonly used for approval of oncology drugs in part due to the serious and life-threatening nature of cancer and because of available intermediate clinical endpoints likely to predict clinical benefit.
Unlearn.AI, which has built a machine learning platform that creates “digital twin” profiles of patients in clinical trials, has raised $15 million to expand partnerships and accelerate regulatory approval.
Q4 and full-year 2022 financial statements have revealed several companies slashing I-O pipelines. Here are just some of the factors at play.
There’s no shortage of information dedicated to reconciling the rewards and risks of cell and gene therapies, and how payers and employers can best provide access to potentially transformative treatments while factoring in price and affordability. We believe that the classical game theory paradox, the “prisoner’s dilemma,” may provide useful insights in helping the various stakeholders develop solutions for how best to cover CGTs.
Clinical trials for BioNTech’s cancer vaccines should start this year in Britain, marking an important step towards their possible sale on the open market, the German company’s top executive Ugur Sahin told magazine Der Spiegel.
Over the past decade, mobile devices, sensors, and wearables have become more common in clinical trials, improving patient-centricity and accessibility. However, despite improving patient recruitment, retention, and satisfaction in research, these innovations have also imposed an increased burden on on-site staff – as well as patients.