Business Trends– category –
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Business Trends
PMDA’s 2026 Strategy: Streamlining Approvals for Next-Gen Regenerative Medicine, Including iPSCs
独立行政法人 医薬品医療機器総合機構 (PMDA) Japan Overview Japan's Pharmaceuticals and Medical Devices Agency (PMDA) has detailed its 2026 operational strategy for approving novel pharmaceuticals, medical devices, and regenerative medicin... -
Business Trends
Vertex’s Zimislecel Cell Therapy Achieves Insulin Independence in 10 of 12 Type 1 Diabetes Patients
Breakthrough T1D Australia Overview Vertex Pharmaceuticals announced highly promising results from its FORWARD-101 trial of Zimislecel (formerly VX-880), an iPSC-derived cell therapy for Type 1 Diabetes (T1D). Ten of 12 participants achi... -
Business Trends
Axtria Acquires Conexus Solutions: Forging an End-to-End AI-Native Commercialization Stack in Life Sciences
PrivSource USA Overview Axtria has acquired Conexus Solutions, a strategic move highlighting 2026's active AI/ML buyout landscape. This acquisition integrates Axtria's agentic AI platform with Conexus's CRM execution expertise to build a... -
Business Trends
SuperMeat Secures $6M in Funding, Accelerating Commercialization of Cultivated Chicken for Swiss Market Entry
PPTI News - Protein Production Technology International UK Overview SuperMeat has raised $6 million in Series A-4 funding, part of a targeted $10 million round, to accelerate the commercialization of its cultivated chicken technology and... -
Business Trends
ProBio and Curocell Achieve BLA Approval for Next-Gen CD19-Targeted CAR-T Therapy, Initiating Commercial Production in South Korea
ProBio CDMO South Korea Overview ProBio CDMO and Curocell have secured Biologics License Application (BLA) approval for anbalcabtagene autoleucel (Anbal-cel; CRC01), their next-generation CD19-targeted CAR-T cell therapy for relapsed or ... -
Business Trends
Terumo BCT and Steminent Partner to Automate Mesenchymal Stem Cell Manufacturing for Late-Stage Clinical Commercialization
Terumo Blood and Cell Technologies Taiwan Overview Terumo Blood and Cell Technologies (Terumo BCT) and Taipei-based Steminent Biotherapeutics Inc. have announced a strategic collaboration to accelerate late-stage manufacturing readiness ... -
Business Trends
Helios Advances ARDS Therapy Approval, Bolstering Regenerative Medicine CDMO with New Kobe Manufacturing Hub
FISCO Japan Overview Helios is progressing towards regulatory approval for its Acute Respiratory Distress Syndrome (ARDS) therapeutic, HLCM051, while simultaneously enhancing its Contract Development and Manufacturing Organization (CDMO)... -
Business Trends
Aldevron and Minaris Renew Lentiviral Plasmid Agreement, Bolstering Critical Supply for Advanced Cell and Gene Therapies
BioBuzz USA Overview Aldevron and Minaris have renewed their lentiviral plasmid licensing agreement, significantly expanding access to scalable plasmid solutions essential for advanced cell and gene therapy (CGT) developers. This collabo... -
Business Trends
Meatly Secures $14M Series A to Build Europe’s Largest Cultivated Meat Facility in London
Green Queen Media UK Overview British food tech firm Meatly has raised £10 million ($14.1 million) in Series A funding to construct a 20,000-liter cultivated meat pilot plant in London, set to become Europe's largest. The company, which ... -
Business Trends
FDA Finalizes Guidance on CMC Flexibility for Cell and Gene Therapies, Expediting Access to Advanced Treatments
Regulatory Focus USA Overview The U.S. FDA has issued final guidance outlining flexible Chemistry, Manufacturing, and Controls (CMC) requirements for cell and gene therapy (CGT) products, recognizing their inherent complexities compared ...