The U.S. FDA has approved Otarmeni (lunsotogene parvec-cwha), Regeneron Pharmaceuticals’ gene therapy for severe-to-profound sensorineural hearing loss caused by biallelic OTOF gene variants. Otarmeni is the first approved gene therapy for genetic hearing loss and the first dual-AAV vector-based gene therapy to reach approval. The decision is notable not only for rare disease innovation, but […]
UCB has announced an agreement to acquire U.S.-based Neurona Therapeutics for up to $1.15 billion, extending its long-established epilepsy franchise into regenerative medicine and advanced therapies. Neurona’s lead asset, NRTX-1001, is a neuronal cell therapy being developed in Phase I/II trials for drug-resistant mesial temporal lobe epilepsy. Designed as a single-dose approach aimed at restoring […]
Eli Lilly and Company has announced an agreement to acquire Houston-based biotech CrossBridge Bio in a deal valued at up to $300 million, adding an early-stage dual-payload ADC platform to its oncology pipeline. Founded in 2023, CrossBridge is a preclinical company built around technology originating from UTHealth Houston. Key points Total deal value of up […]
Gilead Sciences has announced an agreement to acquire Germany-based clinical-stage biotech Tubulis in a deal valued at up to $5 billion, expanding its oncology pipeline through next-generation antibody-drug conjugate, or ADC, technology. The acquisition adds Tubulis’ lead programme TUB-040, along with its proprietary Tubutecan linker-payload technology and broader ADC platform. The transaction also builds on […]
On March 27, the U.S. FDA approved Rocket Pharmaceuticals’ gene therapy Kresladi for severe Leukocyte Adhesion Deficiency-I (LAD-I). Kresladi is the first approved gene therapy for LAD-I. The decision marks an important step forward for gene therapy in ultra-rare diseases, where both clinical value and execution capability remain critical. Key points First approved gene therapy […]
Last week, Greenstaff Life Sciences attended BIOCHINA2026 in Suzhou, China. Hiroshi Yamaguchi, Head of Greenstaff Life Sciences, and Summer Wang, Director of Greenstaff Medical China, attended the conference and engaged in discussions and exchanges across the life sciences community. Across the event, strong discussions took place around innovation, collaboration, and the future of biotech in […]
In March 2026, Japan’s Ministry of Health, Labour and Welfare (MHLW) granted conditional marketing authorization to two regenerative medicine products derived from induced pluripotent stem cells (iPSCs). The decision represents a significant milestone for the regenerative medicine sector, as these therapies could become the first iPSC-based treatments to receive regulatory approval globally. Since induced pluripotent […]
Gilead Sciences has entered into a definitive agreement to acquire Arcellx for approximately $7.8 billion, securing full ownership of its next-generation CAR-T program. Transaction & Development Overview Total deal value: approximately $7.8B (upfront plus contingent value rights) Lead asset: anitocabtagene autoleucel (anito-cel) BCMA-directed CAR-T therapy Target indication: relapsed/refractory multiple myeloma Clinical studies indicate deep and […]
After a prolonged period of limited public market activity, the US biotech sector saw a notable shift last week. Several biotech companies completed IPOs or filed to go public, collectively raising more than $1 billion. Leading industry media have described this as a selective reopening of the IPO market, rather than a broad-based recovery. Recent […]
Monash University / Monash Health have announced that a patient with systemic lupus erythematosus (SLE) has achieved remission following treatment with CAR-T cell therapy.This represents the first clinical application of CAR-T therapy for an autoimmune disease in Australia, extending a modality long established in haematological oncology into a new therapeutic area. CAR-T cell therapy involves […]