Astellas Pharma
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Astellas’s CAR Tech Deals Speed Up Its Pursuit of In Vivo Cancer Cell Therapies
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.
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Manufacturing Issues Block Astellas From a First-in-Class Cancer Drug Approval
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.
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Astellas Drug Acquired in $5.9B Deal Wins FDA Approval in Vision-Loss Disorder
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.
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Astellas Strikes Another Deal to Expand in Cancer, Partnering With PeptiDream
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.
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FDA Approves First-Of-Its Kind Drug to Ease Menopause Symptoms
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.
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Eyeing Its Next Blockbuster, Astellas Lines Up $5.9B Iveric Bio Acquisition
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.
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Digital transformation: Reimagining clinical trial management
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.
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Astellas pays Sutro Bio $90M to partner on cancer drugs that make cold tumors hot
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.
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Astellas Pharma reports fourth patient death in gene therapy clinical trial
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.
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Trayt Health Seeks to Increase Access to Diagnoses and Treatments
CEO Malekeh Amini explains how Trayt Health can bridge the gap for patients seeking neurological care.
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Astellas’ Audentes Therapeutics discloses third patient death in gene therapy trial
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.
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Audentes – bought by Astellas for $3B – discloses new patient death, gene therapy trial hold
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.
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Astellas partners with Adaptimmune in latest move into cell therapy
The companies will work to develop allogeneic CAR-T and T-cell receptor therapies. Astellas has made multiple moves into cell and gene therapy in the past month.
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Astellas buys Xyphos – and its cell therapy platform – for $665M
The deal comes less than a month after the Japanese drugmaker said it would spend $3 billion to acquire gene therapy developer Audentes Therapeutics.
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Astellas dives into gene therapy with $3B acquisition of Audentes Therapeutics
Shares of Audentes rose more than 100% following news that the Japanese drugmaker would acquire it. The company’s lead candidate is a gene therapy for a rare muscular weakness disorder, currently in a Phase I/II study for which it presented data in October.
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Artificial Intelligence, BioPharma
Concerto HealthAI, Astellas partner on RWE in acute myeloid leukemia
The partnership will focus on using real-world evidence to improve understanding of responses among patients with acute myeloid leukemia whose disease carries mutations in the FLT3 gene. Astellas markets a drug for FLT3-positive AML, Xospata, approved in November.