Japan Conditionally Approves World’s First iPS-Derived Therapies
Summary:
Japan has granted conditional approval for the world’s first commercial drugs derived from induced pluripotent stem (iPS) cells: ReHeart for severe heart failure caused by ischemic cardiomyopathy and Amchepry for Parkinson’s disease. Developed by Cuorips Inc., Sumitomo Pharma Co., and Racthera Inc., the therapies received early approval based on safety data and must confirm efficacy within seven years while treatments could begin as early as summer.
FDA Lifts Clinical Hold on Intellia’s CRISPR Gene Therapy Trials
Summary:
The U.S. Food and Drug Administration has lifted the clinical hold on Intellia Therapeutics’ phase 3 Magnitude trial of the CRISPR gene therapy nexiguran ziclumeran (nex-z) for transthyretin amyloidosis after implementing new safety monitoring and patient eligibility restrictions following a fatal liver toxicity case.
Roche Invests $480M to Expand South Korea’s Global Clinical Trial Ecosystem
Summary:
Roche will invest about $480 million in South Korea’s biopharma sector through a partnership with the South Korea Ministry of Health and Welfare to strengthen the country’s clinical trial ecosystem, R&D capabilities, and biotech talent.
Moderna Settles mRNA Vaccine Patent Dispute for Up to $2.25B
Summary:
Moderna agreed to pay up to $2.25 billion to Arbutus Biopharma and Genevant Sciences to settle a patent dispute over lipid nanoparticle (LNP) technology used in its mRNA vaccines, avoiding a major trial and larger potential damages.
Servier to Acquire Day One Biopharma for $2.5B to Expand Rare Cancer Portfolio
Summary:
Servier will acquire Day One Biopharmaceuticals for about $2.5 billion, gaining the pediatric brain cancer drug Ojemda (tovorafenib) and expanding its rare oncology pipeline. The deal strengthens Servier’s position in glioma treatments alongside Voranigo and supports the company’s broader strategy to lead in rare cancers and reach €10 billion in annual sales by 2030.
