The FDA approved Astellas’s Vyloy as a treatment for advanced cases of gastric or gastroesophageal junction (GEJ) adenocarcinoma positive for a protein called claudin 18.2. It’s the first FDA-approved therapy for this target.
Astellas secured an exclusive option to license global rights to an AviadoBio gene therapy in development as a one-time treatment for a certain type of frontotemporal dementia. A Phase 1/2 test of the AviadoBio gene therapy is ongoing.
Closing cancer health equity gaps require medical breakthroughs made possible by new funding approaches.
A Q&A with Naoki Okamura revealed that when it comes to cell and gene therapies, the CEO of Astellas Pharma believes risk-taking is a must for eventual success.
Two Japanese pharmaceutical companies and a bank are teaming up to form a joint venture to advance therapeutic discoveries from academia. The focus will be innovation from universities in Japan.
Astellas Pharma is working with Kelonia Therapeutics, a startup that develops in vivo CAR T-therapies with technology that precisely delivers genetic cargo to cells. The collaboration combines this tech with a platform from Xyphos Biosciences, a cell therapy developer that Astellas acquired in 2019.
Astellas Pharma’s zolbetuximab was on track to become the first gastric cancer drug that targets claudin 18.2, a protein found on cancerous stomach cells. Others with clinical-stage programs addressing this target include AstraZeneca and Bristol Myers Squibb.
Hear executives from Quantum Health, Surescripts, EY, Clinical Architecture and Personify Health share their views on digital transformation in healthcare.
Izervay, a drug developed by Astellas Pharma subsidiary Iveric Bio, is now the second approved therapy for the degenerative vision-loss disorder geographic atrophy. The regulatory decision comes as safety concerns emerge around the first therapy for the disease, an Apellis Pharmaceuticals product.
Astellas Pharma has identified targeted protein degradation as one of the key areas for growth. The PeptiDream alliance is the latest one Astellas has struck in this particular area of drug research as it aims to find new ways to go after difficult cancer targets.
Astellas Pharma won FDA approval for Veozah, a new menopause drug. The once-daily pill offers a new non-hormonal treatment option for addressing menopausal symptoms.
Astellas Pharma is acquiring Iveric Bio in a deal that brings a vision loss-disorder drug on track for an FDA decision this summer. Iveric’s pipeline also includes genetic medicines that fit Astellas’s gene therapy strategy.
As technology advances, AI-powered tools will increasingly reduce the administrative burdens on healthcare providers.
Decentralized clinical trial approaches helped the pharma industry navigate through Covid-19. Now it is becoming increasingly clear that there’s a need for a hybrid approach to decentralized clinical trials that considers the perspectives of patients and the impact to clinical trial sites.
Astellas Pharma has a new partner in the R&D of a type of cancer drug called an antibody drug conjugate (ADC). The Japanese pharma company reached across the Pacific Ocean to collaborate with Sutro Biopharma in a bet that Bay Area-based firm’s technology can deliver more powerful ADCs.
The death occurred less than two weeks after Astellas Pharma reported that the patient developed liver problems after being dosed with the experimental gene therapy for a rare neuromuscular disorder. Astellas said the cause of death is still under investigation, and the FDA has placed a clinical hold on the study.
The clinical trial had already been placed on hold in connection with the two prior patient deaths, which were linked to the higher dose of 300 trillion viral vectors per kilogram, while no deaths have been reported among those receiving the lower dose of 100 trillion vectors.
The company disclosed in a letter to the X-linked myotubular myopathy patient community that a second child in its Phase I/II study had died. A formal clinical hold has been placed on the trial.