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Current events
Stay ahead of biotech and pharma developments with F2i Partners’ Current Events — timely analysis linking FDA updates, clinical news, and manufacturing trends to validation, quality, and commercialization strategy.


From statistics to AI: the next leap in biotech
In biotech, we live in the age of data, but data alone isn’t intelligence. The real breakthrough happens when statistical rigor meets artificial intelligence (AI). So, how are they connected and why does this relationship matter for the future of biotech? 🔹 1. Statistics vs. AI: Not Competitors, but Collaborators Statistical models are about understanding why something happens. They’re interpretable, grounded in theory, and help us make inferences. AI models (think machine
Admin Biz
Oct 132 min read


From Promise to Proof: Arcturus Therapeutics and the Next Frontier of mRNA Medicine
Industry Insights by F2i Partners The biotechnology industry often celebrates breakthroughs in the lab, but real value is realized when those discoveries can be manufactured, validated, and delivered at scale. Few examples illustrate this tension between innovation potential and execution reality better than Arcturus Therapeutics (NASDAQ: ARCT) — a company quietly advancing next-generation mRNA medicines while navigating a turbulent investor landscape. --- 1. The Market Narra
Admin Biz
Oct 114 min read


Monopar’s Wilson Disease Bet: When a “Math Error” Becomes a Pipeline
A rare sight in biotech: a late-stage asset abandoned by a big pharma is being revived—not because the biology changed, but because the...
Admin Biz
Oct 104 min read


🔬 Regeneron’s “Incremental Win.” What It Reveals About Biopharma Resilience
When BioPharma Dive reported this week that Regeneron’s Libtayo gained a new FDA approval in the adjuvant setting for cutaneous squamous...
Admin Biz
Oct 102 min read


Fortress Biotech FDA Complete Response Letter: What It Means for the Future of Biotech Manufacturing and Validation
In a development that sent shockwaves through the biotech sector, Fortress Biotech recently received a Complete Response Letter (CRL) from the FDA for its promising gene therapy candidate CUTX-101 . The news caused shares to plummet and raised critical questions about the industry’s ability to consistently deliver therapies that meet both clinical and manufacturing standards. While the FDA did not cite clinical efficacy concerns, the decision underscores a reality that biote
Admin Biz
Oct 13 min read
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