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Thermo Fisher wins FDA nod for NGS companion test tied to Bayer lung drug
Thermo Fisher received FDA approval for a next-generation sequencing–based companion diagnostic that identifies patients eligible for Bayer’s newly approved HER2-directed lung cancer therapy. The...
Arrowhead wins FDA approval: RNAi reaches commercial stage
Arrowhead Pharmaceuticals secured FDA approval for its RNA interference therapy Redemplo (plozasiran) for familial chylomicronemia syndrome, marking the company’s transition into a...
J&J buys Halda for $3.05B: precision oncology expansion
Johnson & Johnson agreed to acquire Halda Therapeutics for $3.05 billion in cash to augment its oncology pipeline with Halda’s precision oncology candidates, led by clinical-stage HLD-0915 for...
Ex-Grail founders pitch cfDNA methylation test for liver disease
Hepta, founded by veterans of methylation-based liquid biopsy work, released proof-of-concept data indicating circulating cell-free DNA methylation signatures reflect liver disease biology and...
Profluent raises $106M: AI protein design scales toward therapeutics
Profluent closed a $106 million funding round led by Altimeter Capital and Bezos Expeditions to expand its large-scale AI models for protein design across therapeutics, agriculture and...
FDA to allow one post-meeting email clarification: small regulatory change, material impact
The FDA updated its meeting practices to permit companies to send a single follow-up email to clarify one question after official meetings. The agency said the measure aims to reduce ambiguity and...
Abbott to buy Exact Sciences: $21B deal reshapes cancer‑testing market
Abbott moved to acquire Exact Sciences in a roughly $21 billion cash deal that would fold Cologuard and emerging blood‑based screening assets into Abbott’s diagnostics footprint....
Novartis pays up for Avidity – doubles down on neuromuscular RNA bets
Novartis closed on a large acquisition of Avidity Biosciences, paying a multibillion‑dollar premium to secure Avidity’s antibody‑oligonucleotide conjugates and late‑stage pipeline. Management...
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...