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Celaid Therapeutics Secures Additional Funding for U.S. Clinical Trials of CLD-001

Celaid Therapeutics Secures Additional Funding for U.S. Clinical Trials of CLD-001

Celaid Therapeutics Inc., a biotechnology startup, has completed the second close of its Series B financing round, raising an additional JPY 400 million (approximately USD 2.6 million). New investors, including Shionogi & Co., Ltd. and Teikoku Ventures, Inc., joined this round. This funding, combined with support from AMED's 'Strengthening Program for Pharmaceutical Startup Ecosystem,' brings Celaid's total cumulative funding to approximately JPY 3.42 billion (approximately USD 22.1 million). The proceeds are primarily earmarked for manufacturing, safety assessment, clinical development, and regulatory activities to support the Investigational New Drug (IND) application and the initiation of clinical trials in the United States for CLD-001. CLD-001 is a novel ex vivo-expanded hematopoietic stem cell (HSC) therapy product designed for severe pediatric non-malignant diseases.
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HHS Unveils AI Initiatives to Accelerate U.S. Clinical Trials

HHS Unveils AI Initiatives to Accelerate U.S. Clinical Trials

The U.S. Department of Health and Human Services (HHS) has announced a new program and three complementary projects aimed at significantly speeding up clinical trials through the integration of artificial intelligence (AI), advanced computational models, and real-time analysis. The core initiative, named SURPASS (Simulation-augmented, Real-time Platform Adaptive Seamless Trials), seeks to develop AI-powered platforms that will continuously and adaptively support clinical trial designs. This program includes the creation of a phaseless design engine to simulate trials for faster results with fewer patients, a continuous inference engine for real-time data analysis and trial adaptations, and an agentic AI operations layer to automate startup activities and data collection. These efforts are part of a broader strategy by HHS to transform U.S. clinical trials, building on previous initiatives like Operation TrialBlazer and the FDA's pilot program using AI for real-time clinical trial data monitoring. The goal ...
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CSL Licenses Anti-Claudin-1 Antibody from Alentis Therapeutics in $1.55 Billion Deal for Kidney and Liver Diseases

CSL Licenses Anti-Claudin-1 Antibody from Alentis Therapeutics in $1.55 Billion Deal for Kidney and Liver Diseases

CSL Licenses Anti-Claudin-1 Antibody from Alentis Therapeutics in $1.55 Billion Deal for Kidney and Liver Diseases
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AstraZeneca and Daiichi Sankyo Collaborate on Clinical Trials for Datopotamab Deruxtecan in Cancer Treatment

AstraZeneca and Daiichi Sankyo Collaborate on Clinical Trials for Datopotamab Deruxtecan in Cancer Treatment

AstraZeneca and Daiichi Sankyo Collaborate on Clinical Trials for Datopotamab Deruxtecan in Cancer Treatment
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FDA and SEC Enhance Coordination on Telehealth Prescribing Models, Increasing Scrutiny on Companies

FDA and SEC Enhance Coordination on Telehealth Prescribing Models, Increasing Scrutiny on Companies

FDA and SEC Enhance Coordination on Telehealth Prescribing Models, Increasing Scrutiny on Companies
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Regeneron Expands Global Immunology Alliance with Sanofi, Securing $1 Billion Upfront

Regeneron Expands Global Immunology Alliance with Sanofi, Securing $1 Billion Upfront

Regeneron Expands Global Immunology Alliance with Sanofi, Securing $1 Billion Upfront
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Soda Steel Gummies Marketed for Male Vitality Lack Clinical Trial Evidence

Soda Steel Gummies Marketed for Male Vitality Lack Clinical Trial Evidence

Soda Steel Gummies Marketed for Male Vitality Lack Clinical Trial Evidence
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ProMIS Neurosciences Appoints Ivana Rubino as Chief Commercial Officer Amidst Ongoing Alzheimer's Drug Trial

ProMIS Neurosciences Appoints Ivana Rubino as Chief Commercial Officer Amidst Ongoing Alzheimer's Drug Trial

ProMIS Neurosciences Appoints Ivana Rubino as Chief Commercial Officer Amidst Ongoing Alzheimer's Drug Trial
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Black Eye Coffee: A High-Caffeine Functional Beverage Gaining Popularity for Productivity

Black Eye Coffee: A High-Caffeine Functional Beverage Gaining Popularity for Productivity

Black Eye Coffee: A High-Caffeine Functional Beverage Gaining Popularity for Productivity
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FDA Launches Expedited IND Pilot Program and Updates Non-Animal Testing Regulations

FDA Launches Expedited IND Pilot Program and Updates Non-Animal Testing Regulations

The U.S. Food and Drug Administration (FDA) has initiated an Expedited Investigational New Drug (IND) Pilot program, now accepting applications. This program aims to accelerate the drug development process by pairing drug sponsors with Qualified Research Institutions (QRIs) to support IND application preparation. The pilot allows for a rolling review of individual IND components during the pre-IND phase, rather than requiring a complete package upfront, with the goal of reducing clinical holds and shortening the drug-to-first-dose timeline. Applications for this pilot are due by October 30, and the FDA anticipates selecting 8–10 sponsor–QRI pairs for the initial cohort. Concurrently, the FDA has issued a direct final rule replacing 'animal tests' with 'nonclinical tests' in its drug and biologics regulations, explicitly allowing non-animal methods like human cell cultures, organs-on-chips, and computer models for pre-human safety assessment. This change does not eliminate animal studies but clarifies that ...
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DHHS Releases 2026 Unified Agenda, Proposing Five Clinical Research Rule Changes

DHHS Releases 2026 Unified Agenda, Proposing Five Clinical Research Rule Changes

The Department of Health and Human Services (DHHS) has released its 2026 Unified Agenda, outlining five proposed regulatory shifts in clinical research. These changes represent the most concentrated set of proposed modifications to clinical research rules in years. Among the key proposals, the Office for Human Research Protections (OHRP) is considering revisions to 45 CFR 46 (RIN 0937-AA16). These revisions aim to introduce exemptions for low-risk research, provide flexibility for de minimis protocol changes, and reduce the burden on learning health systems. The overarching goal is to concentrate oversight on higher-risk activities. Additionally, the Food and Drug Administration (FDA) is targeting July 2026 for an expedited Phase 1 IND reform (RIN 0910-AJ30), which could revise sponsor responsibilities, risk-based exemptions, and Institutional Review Board (IRB) requirements in early development, with the explicit goal of reducing disproportionate burden. The FDA also lists a single IRB rule for cooperativ...
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SGS Offers Comprehensive Services for mRNA Therapeutics and Vaccines Development

SGS Offers Comprehensive Services for mRNA Therapeutics and Vaccines Development

SGS Offers Comprehensive Services for mRNA Therapeutics and Vaccines Development