Regulatory Affairs
The Pill That Promised a Revolution: Why Eli Lilly's Foundayo Is Launching Slower Than Wall Street Expected
Jefferies has revised its debut-quarter US sales estimate for Eli Lilly's oral GLP-1 drug Foundayo (orforglipron) down to $71 million — well below the Wall Street consensus of $130 million and sharply below its own prior estimate of $85 million. With weekly prescriptions hovering around 20,000 and Novo Nordisk's oral Wegovy outpacing it on trajectory, the first oral non-peptide GLP-1 for obesity is generating a very different story than the hype suggested.

Regulatory Affairs
Speed Over Scrutiny? The High-Stakes Gamble Behind the NHS's New Fast-Track Drug Pilots
The UK government and the pharmaceutical industry have launched a series of pilot schemes designed to accelerate NHS patient access to innovative medicines — a direct consequence of the US-UK pharmaceutical trade arrangement that has already rewritten the terms of how Britain prices, approves, and funds new drugs. But with a BMJ analysis warning of £45 billion in diverted NHS resources and up to 229,000 excess deaths by 2036, the pilots are arriving in the middle of one of the most contested healthcare policy disputes in a generation.

MedTech
Cork MedTech Innovator NeuroBell Secures $5.5M to Accelerate Launch of AI Neonatal Seizure Monitor Luna
NeuroBell, a spin-out from University College UCC, has closed a $5.5 million (€4.8 million) funding round led by Elkstone to secure US regulatory clearance and commercialize its AI-powered neonatal seizure detection device, Luna.

Industry
Tapestry VC Closes $80M Fund III Backed by British Business Bank to Target Repeat Founders
Co-founded by Patrick Murphy and David Kelly, Tapestry VC has announced the closing of its $80 million Fund III, tripling its capital base with support from OpenAI CFO Sarah Friar and the British Business Bank.

MedTech
AI Real Estate Pioneer Build Raises $8.5M Seed Round to Automate Infrastructure Workflows
Build, a startup co-founded by James Stirrat-Ellis and Ben McClusky, has secured $8.5 million in seed funding led by Index Ventures to expand Dougie, its AI platform for real estate infrastructure workflows.

Industry
GovTech Startup Xylo Raises £2.8M Led by CapitalT to Solve Local Council Planning Bottlenecks
Co-founded by Habs Isabelle Kim and Dermot O'Riordan, government technology startup Xylo has raised £2.8 million in pre-seed funding to deploy AI agents that speed up local planning departments.

Regulatory Affairs
Data Integrity and Quality Oversight: Analyzing the FDA Warning Letter for Sanofi's Waterford Site
Following a January 2026 inspection, the FDA has issued a formal warning letter to Genzyme Ireland Limited in Waterford, citing data integrity concerns, uncontrolled checklists, and quality unit oversight gaps in the manufacturing of Thymoglobulin and Altuviiio.

Regulatory Affairs
A Global Milestone for Wellness: Chanelle McCoy Health Secures Historic Dual SFDA and European Novel Food Regulatory Approvals
In a landmark world-first, Irish-founded Chanelle McCoy Health has received official regulatory approvals from the Saudi Food and Drug Authority and confirmation of safety under EU Novel Food guidelines for its Pureis® Ultra Pure CBD range.

Regulatory Affairs
The Digital and Regulatory Frontier: Top 10 Technical and GMP Trends Shaping Pharma in 2026
A comprehensive technical report detailing the top 10 trends in Good Manufacturing Practice (GMP), sterile manufacturing, GAMP 5, Quality 4.0, and continuous manufacturing currently reshaping the global pharmaceutical landscape.

Industry
Funding the Future: Inside the €75k Women TechEU and £10M Createch Grants for Startups and SMEs
An in-depth analysis of two newly opened funding opportunities—Women TechEU and Innovate UK's Next Wave Createch—designed to support early-stage deep tech and creative technology innovators across Europe and the UK.

Regulatory Affairs
FDA Fires Warning Shot at Sanofi's Irish Plant Over Data Cover-Up and Altuviiio Quality Failings
The FDA has issued a formal warning letter to Sanofi's Waterford facility, Genzyme Ireland Limited, citing data integrity breaches, discarded quality records, and botched deviation investigations in the production of haemophilia drug Altuviiio and transplant therapy Thymoglobulin.

Pharmaceutical
Cold Chain Management and Good Distribution Practice (GDP) for Biologics and Vaccines
An academic analysis of temperature-sensitive supply chains, GDP compliance, distribution monitoring, and shipping deviation management.
