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Bayer’s HER2 lung pill wins FDA: rapid approval to meet recent competitor
The FDA granted accelerated approval to Bayer’s oral HER2‑targeted therapy for advanced non‑small cell lung cancer with specific HER2 mutations, moving to preserve competitiveness after a recent...
Arrowhead’s RNAi drug wins FDA — price war looms with Ionis
Arrowhead Pharmaceuticals secured FDA approval for plozasiran (Redemplo) to treat familial chylomicronemia syndrome, marking the RNAi company’s transition to commercial stage and setting up direct...
Prime editing variant: one‑agent, many diseases – suppressor tRNAs advance
Researchers at the Broad Institute published a prime‑editing strategy that converts endogenous tRNAs into suppressor RNAs (PERT), enabling a single editing agent to rescue premature termination...
Profluent raises $106M: AI protein design hits commercial stride
Profluent closed a $106 million financing led by Altimeter Capital and Bezos Expeditions to scale large‑model protein design for therapeutics, enzymes and biomanufacturing. The company said its...
Function Health hits $2.5B valuation after $298M Series B
Function Health secured a $298 million Series B led by Redpoint, driving a $2.5 billion valuation for the consumer lab‑testing platform. The Austin startup provides subscriptions for hundreds of...
Aspen raises $115M: personalized Parkinson’s cell therapy pushes toward Phase III
Aspen Neuroscience closed a $115 million Series C to advance its autologous cell therapy programs for Parkinson’s disease and accelerate an expected Phase III start next year. The financing, which...
Tessera to start first human trial: gene‑writing moves into the clinic
Tessera Therapeutics confirmed it will begin its first‑in‑human trial next month for an in‑vivo gene‑writing platform targeting a rare genetic disease, marking a milestone for a new class of...
Congress moves on biomanufacturing: bill to create National Biopharma Manufacturing COE
Bipartisan lawmakers introduced legislation to establish a National Biopharmaceutical Manufacturing Center of Excellence as a public‑private partnership to advance domestic biomanufacturing,...
Novartis pays $12B for Avidity – neuromuscular push
Novartis completed a $12 billion acquisition of Avidity Biosciences to secure late‑stage antibody‑oligonucleotide conjugates and accelerate its neuromuscular disease strategy. The deal transfers...
J&J pays $3.05B for Halda – adds precision oncology arm
Johnson & Johnson agreed to buy Halda Therapeutics for $3.05 billion in cash to expand its oncology pipeline with Halda’s precision oncology candidates, led by HLD‑0915 for metastatic...
Abbott eyes Exact Sciences... diagnostics bet
Bloomberg and other outlets reported that Abbott Laboratories is in acquisition talks to buy Exact Sciences, the diagnostics company behind Cologuard and newly launched multi‑cancer and monitoring...
Tessera to begin first human gene‑writing trial – Flagship unit moves to clinic
Tessera Therapeutics, backed by Flagship Pioneering, confirmed plans to start the first human trial of its in vivo gene‑writing platform next month in adults with a rare genetic disease. The Phase...
Prime editing: one platform for many diseases – suppressor tRNAs and PERT
Two breakthrough reports expanded prime editing’s therapeutic toolbox. David Liu’s Broad Institute team described a prime editing‑mediated readthrough approach (PERT) that converts an endogenous...
Genomic AI scales gene design and interpretation – semantic models and Genos
Researchers reported two advances in AI for genomics. One team used large genomic language models to design entirely new functional genes by leveraging patterns learned from hundreds of billions...
AI protein design draws capital—Profluent and Iambic scale platforms
Two AI‑focused protein design firms announced major financings to accelerate therapeutics and enzyme development. Profluent raised $106 million to expand large‑scale models for protein design and...
Genetic elements stabilize ecDNA; tumor‑reactive CD8 clusters mapped
A Nature study identified specific genetic elements that promote retention of extrachromosomal DNA (ecDNA) in cancer cells, clarifying a key mechanism behind oncogene amplification and rapid tumor...
FDA clears targeted oncology drugs – Komzifti and Bayer’s Hyrnuo
Regulators advanced two targeted oncology approvals. The U.S. FDA approved ziftomenib (Komzifti), a selective oral menin inhibitor from Kura Oncology/Kyowa Kirin, for relapsed/refractory...
U.S. biomanufacturing push gains momentum – COE bill and Thermo Fisher centers
U.S. lawmakers introduced bipartisan legislation to create a National Biopharmaceutical Manufacturing Center of Excellence (COE) to accelerate domestic manufacturing methods, regulatory...
Abbott in talks — Exact Sciences acquisition could reshape cancer testing
Bloomberg reported that Abbott Laboratories is in talks to acquire cancer-diagnostics company Exact Sciences, potentially within days. Exact Sciences sells the stool-based colorectal-screening...
Prime editing... one platform to treat many genetic diseases
David Liu’s Broad Institute team published a prime-editing approach called PERT that permanently converts an endogenous tRNA into a suppressor tRNA, enabling one editing agent to rescue diverse...