Microsoft and DISG announced the Agentic AI Accelerator program as part of Singapore's Enterprise Compute Initiative. The program will offer up to 300 Singapore businesses baseline support of up to S$250,000 in Azure cloud credits, AI training tools, and potential funding up to S$700,000 in services for select businesses to co-develop agentic AI roadmaps.
NTT has developed the world's first AI technology capable of visualizing expert decision-making processes with approximately 90% accuracy. The system analyzes dialogue data from areas such as security incident response and call center operations, offering unprecedented insights into expert knowledge systems.
University Hospitals of Leicester NHS Trust and University Hospitals of Northamptonshire NHS Group signed a Memorandum of Understanding with Microsoft to develop AI healthcare solutions. The partnership includes ambient AI scribes for consultations, AI-assisted clinical coding, and corporate service automation potentially worth £6 million annually.
AI Scribes Show Promise: A randomized clinical trial of ambient AI scribes (Microsoft DAX vs. Nabla) demonstrated that Nabla users experienced a 9.5% decrease in time-in-note versus control group, with both systems showing modest improvements in physician burnout and work exhaustion[1].
FDA AI Device Approvals: The FDA has authorized over 1,200 AI-enabled medical devices, with 956 (77%) focused on radiology applications. Approvals continue to accelerate with 148 new authorizations from January to May 2025[185].
The FDA recommended that Sarepta Therapeutics remove its voluntary hold on United States shipments of Duchenne muscular dystrophy gene therapy delandistrogene moxeparvovec-rokl (Elevidys) for ambulatory patients. This follows safety reviews and protocol modifications.
FDA accepted Abeona Therapeutics' resubmitted Biologics License Application for Pz-cel (prademagene zamikeracel), a potential first cell-based gene therapy for Recessive Dystrophic Epidermolysis Bullosa (RDEB). Decision expected by April 29, 2025.
| Gene Therapy | Company | Indication | Current Status | Key Update |
|---|---|---|---|---|
| Elevidys (delandistrogene moxeparvovec-rokl) | Sarepta Therapeutics | Duchenne Muscular Dystrophy | FDA-approved; shipments resumed | Voluntary hold lifted for ambulatory patients |
| Pz-cel (prademagene zamikeracel) | Abeona Therapeutics | Recessive Dystrophic Epidermolysis Bullosa | FDA review | BLA accepted; decision by April 29, 2025 |
| NGN-401 | Neurogene | Rett Syndrome | Phase 1/2 ongoing | Registrational trial design announced for EMBOLDEN study |
Accelerated Approvals Expected: The FDA's accelerated approval pathway is becoming the "new norm" for gene therapy, with 6+ companies potentially receiving approvals in 2025-2026 after alignment with FDA on surrogate endpoints[70].
Investment Growth: Over 30 cell and gene therapies have been FDA-approved as of early 2025, with industry experts anticipating 30-50 additional approvals by 2030[70].
FDA granted fast track designation to TRE-515 in combination with radioligand therapy for treating PSMA-positive metastatic castration-resistant prostate cancer. This combination approach seeks to accelerate precision medicine beyond current standards of care.
Randomized phase 2 trial evaluating flexible and extended dosing of ¹⁷⁷Lu-PSMA-617 up to 12 cycles versus standard 6 cycles in metastatic castration-resistant prostate cancer. The study aims to assess 2-year survival rates with response-based flexible dosing.
| Radioligand Agent | Target | Indication | Development Stage | Recent Development |
|---|---|---|---|---|
| ¹⁷⁷Lu-PSMA-617 (Pluvicto) | PSMA | mCRPC | FDA-approved | Indication expanded to pre-chemotherapy setting |
| TRE-515 + radioligand | PSMA | PSMA+ mCRPC | Phase 1 | FDA Fast Track designation granted |
| ¹⁶¹Tb-PSMA-617 | PSMA | mCRPC | Pilot studies | Superior tumor-absorbed doses vs ¹⁷⁷Lu-PSMA-617 |
| ¹⁷⁷Lu-PNT2002 | PSMA | mCRPC | Phase 3 (SPLASH) | Lead-in cohort shows median rPFS 11.5 months |
Re-treatment Efficacy: Mayo Clinic data showed that re-treatment with Lu-177 PSMA-617 after initial course completion resulted in 45% PSA decline ≥50% and median overall survival of 14.5 months from re-treatment[117].
Extended Dosing Rationale: The FLEX-MRT trial hypothesizes 2-year survival rates of 55% with flexible dosing (up to 12 cycles) versus 30% with standard 6-cycle protocol, potentially optimizing treatment efficacy.
| Development | Category | Impact | Link |
|---|---|---|---|
| FDA AI Device List Updated - Over 1,000 Authorizations | AI Regulatory | Milestone in AI medical device adoption | FDA AI Device List |
| Microsoft AI Diagnostic Tool (MAI-DxO) Outperforms Doctors | AI Clinical | 85% accuracy vs average physician performance | Healthcare Leader News |
| FDA Expands Pluvicto Indication to Pre-Chemotherapy Setting | Radioligand | Earlier treatment access for mCRPC patients | Targeted Oncology |
| CRISPR Clinical Trials Reach ~250 Active Studies | Gene Therapy | Expanding therapeutic applications beyond blood disorders | CRISPR Medicine News |
August 27, 2025: FDA decision expected for zopapogene imadenovec (PRGN-2012), an adenovirus vector-based gene therapy for recurrent respiratory papillomatosis. If approved, this would be the first FDA-approved pharmacologic treatment addressing the underlying HPV cause of RRP[146].
The convergence of AI with traditional therapeutics is evident in Microsoft's NHS partnership and Singapore's national AI acceleration program. These initiatives suggest 2025 will be pivotal for clinical AI deployment at institutional scale.
Beyond Lu-177 PSMA, next-generation agents like ¹⁶¹Tb-PSMA-617 show promise for improved dosimetry. The field is expanding from prostate cancer to broader solid tumor applications, with combination strategies like TRE-515 representing the future of precision radioligand therapy.