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What’s in Today’s Brief? (February 18th Preview)
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AI decodes yeast DNA: manufacturers chase cheaper protein drugs
MIT chemical engineers published a study introducing an AI-driven method that programs industrial yeast to produce biopharmaceutical proteins faster and at lower cost. The team trained large language models on yeast genomic and regulatory sequences to predict DNA edits that improve expression and secretion of target proteins. The approach aims to shorten strain-engineering timelines and reduce reliance on iterative wet-lab screening. The research was led at MIT and validated on multiple industrial yeast strains and expression systems. By automating the design of regulatory sequences and production pathways, the method could compress early process development and improve yield for vaccines and biologics. Large language models (LLMs) are statistical models trained on extensive sequence or textual data to predict likely next elements—here repurposed to propose genetic edits for yeast optimization. A separate study echoed the same concept: modeling yeast DNA “language” to tune expression and scale protein output. Together, the papers show converging industry interest in AI-first strain design, signaling faster adoption of generative models in biologics manufacturing workflows.
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FDA backtracks: Moderna’s mRNA flu shot put back on review track
The FDA reversed an earlier refuse‑to‑file decision and agreed to review Moderna’s revised mRNA influenza vaccine submission after the company amended its filing and the agency held an internal senior‑leader meeting. The regulator will consider full approval for adults 50–64 and accelerated approval for those 65 and older, with a post‑marketing study required in older adults. Moderna and STAT reporting show the U‑turn followed high‑level discussions at the agency; the FDA set an August 5 target date for a decision. The split‑indication approach means Moderna may need additional data to win full approval in the oldest cohort, while accelerated approval would permit earlier access pending confirmatory evidence. The reversal highlights an unusual, high‑visibility deviation from prior FDA practice and leaves open questions about internal review processes and precedent for future mRNA vaccine filings.
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Compass nears FDA bid after second pivotal psilocybin victory
Compass Pathways reported a second positive Phase III trial for its synthetic psilocybin candidate COMP‑360 in treatment‑resistant depression, enabling the company to prepare a rolling NDA and pursue U.S. approval. The two successful pivotal trials showed statistically significant improvements versus control on depression scales at six weeks and maintained effects through later time points in at least one study. Compass said it will complete a rolling submission by year‑end and seek regulatory meetings; industry analysts note the data may meet approval thresholds but that detailed safety and remission figures will determine commercial and clinical uptake. The outcome would position COMP‑360 as the first classic psychedelic therapy to secure regulatory clearance in the U.S.
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Novartis bets on macrocycles: $100M now, $1.7B on the table
Novartis executed a strategic partnership to license Unnatural Products’ macrocyclic peptide platform, paying $100 million upfront with the deal carrying potential payments rising to roughly $1.7 billion for cardiovascular applications. The transaction gives Novartis exclusive access to a discovery engine for constrained peptides that can address challenging targets. The deal signals large pharma appetite for next‑generation modalities—macrocycles can combine peptide specificity with drug‑like properties—and underscores business development activity targeting modality expansion. Unnatural Products retains pre‑IND milestone rights and stands to benefit from development and sales milestones and royalties if lead programs advance.
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Merck and Mayo Clinic tie up to fuse clinical data with AI discovery
Merck signed a research and development collaboration with the Mayo Clinic to integrate Mayo Clinic Platform clinical and genomic datasets with Merck’s AI‑enabled virtual cell technologies. The initial focus areas are inflammatory bowel disease, atopic dermatitis, and multiple sclerosis, with the stated goal of accelerating target identification and improving candidate validation. Under the agreement, Merck gains access to Mayo’s clinical registries, biorepositories and computational tools to validate and translate AI‑driven hypotheses into drug discovery programs. Company leadership framed the deal as an effort to combine high‑quality clinical data with machine‑learned insights to raise program success probabilities and speed preclinical decisions.
...and 5 more selected Biotech stories in today’s full edition — or archive.
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