EU non-dilutive funding, FDA and CMC readiness, and capital, licensing and M&A.
What the Clinical Overview (Module 2.5) must cover in an EU hybrid application under Article 10(3), how to justify differences from the reference product, and where assessors push back.
How to build the Clinical Overview for an EU well-established use application under Article 10a: the ten-year test, literature selection, and how to bridge your product to the published evidence.
What Article 12 of Directive 2001/83/EC requires from the Clinical and Nonclinical Expert, what to look for when you appoint one, and the questions to ask before they sign.
What the FDA national priority voucher (CNPV) offers in 2026, how it compares to other expedited programs, and what EU sponsors need ready first.
What a Delaware flip is, when a European biotech should do one, and what US VCs check in diligence. Includes a US-VC readiness checklist.
Biotech M&A targets in 2026: oncology and immunology lead, CVRM fades, China licensing surges. Where buyers are spending and the red flags to check.
Horizon Europe health call 2027: EUR 528M, 14 topics, opens Oct 29 2026, closes Feb 17 2027. Topics, consortium rules and a prep timeline for biotechs.
IHI Call 13 closes Oct 8. The last EIC Accelerator 2026 cut-off is Nov 4. Who can still make it, and what biotech teams should prepare now.
Bluebird Bio almost didn't survive the road to FDA approval — not because the science wasn't there, but because of CMC comparability gaps and pediatric safety signals that weren't built into the development plan. The same patterns are stalling programs today.
Brexit has fundamentally reshaped the regulatory and commercial landscape for UK biotech companies. Navigating parallel pathways across the MHRA, EMA, and FDA requires a new level of strategic coordination — and the companies that adapt fastest will capture the greatest opportunity.
The UK is one of the world's strongest life science ecosystems — but for British biotech companies with global ambitions, moving from a UK-centric operation to a commercially successful international business requires deliberate strategy across regulatory, commercial, and partnership dimensions.
Too many biotech companies treat commercialization as a post-approval problem. The most successful teams start building their commercial strategy years before launch — and it shapes everything from clinical trial design to fundraising.
Launching a drug in Europe and the United States requires fundamentally different strategies. Understanding the regulatory, pricing, and reimbursement landscape in each market is critical for biotech and pharma companies planning cross-border commercialization.
Advances in AI-driven protein design and antibody engineering have dramatically expanded what is possible in biologics discovery. But designing a better antibody is only the first step.
Many biotech teams focus heavily on discovery and clinical data. But regulators are increasingly asking a different question: Can you manufacture your therapy consistently and at scale?
The FDA's recent announcement signals a meaningful shift in how biologics and ultra-rare disease therapies may be evaluated — including openness to smaller, well-justified data packages.
After several recent conversations with biotech and digital health teams, a pattern keeps repeating. Not around the science — that's usually strong. It's around regulation.
Common chemistry, manufacturing, and controls pitfalls that quietly derail small biotech IND timelines, and the practical fixes that keep programs on track.
A 2026 guide to EU and UK non-dilutive funding for biotech, including EIC Accelerator, Horizon Europe, Bpifrance i-Lab, and Innovate UK, with real deadlines and what regulatory-ready applications actually need.
A pre-IND meeting is the cheapest regulatory advice a biotech will ever get, and the most commonly wasted. What to ask, what to include in the briefing book, and where teams lose the value.
What IND-enabling studies are, which ones the FDA expects before first-in-human, how long the package takes, and the sequencing decisions that quietly determine your filing date.
Choosing a CDMO is a regulatory decision, not a procurement one. The criteria that matter, the questions to ask before signing, and the contract terms teams regret leaving out.
The BIOSECURE Act is law and the FDA's PreCheck pilot has named its first participants. Both change how EU biotechs should screen, select, and oversee US CDMOs and CROs.
Practical guidance on FDA and EMA strategy, CMC readiness, and non-dilutive funding — sent only when there is something worth reading.