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FDA rolls out rapid‑response program — hiring surge meets review controversy
The FDA said it is hiring more than 1,000 new staffers and piloting an email 'quick clarification' program to speed sponsor interactions and reduce review uncertainty. Commissioner Marty Makary...
Lilly becomes first $1T drugmaker — employers cut direct obesity‑drug deals
Eli Lilly’s market capitalization briefly exceeded $1 trillion as sales of GLP‑1 obesity and diabetes medicines propelled the company to a new valuation milestone. The surge underscores the...
Ginkgo Datapoints opens Virtual Cell: standard for AI‑driven pharmacology
Ginkgo Bioworks launched the Virtual Cell Pharmacology Initiative (VCPI) through Ginkgo Datapoints to create a standardized, open dataset for virtual cell modeling in drug discovery. VCPI will...
Iambic: two‑year chemistry‑to‑clinic — AI and automation deliver leads
San Diego‑based Iambic is advancing a physics‑informed, automation‑driven platform aimed at compressing the small‑molecule discovery timeline to roughly two years from chemistry to clinic. The...
Ocean Diagnostics vows 3.5‑hour sepsis ID — pilot matched culture at 100%
France‑based Ocean Diagnostics completed a pilot clinical evaluation of a rapid blood test that identified sepsis pathogens and matched gold‑standard blood culture results at 100% while detecting...
Hepta’s cfDNA methylation mirrors liver biology — liquid biopsy for fibrosis
Hepta released proof‑of‑concept data showing cell‑free DNA methylation patterns in plasma reflect liver tissue biology and fibrosis states. The company built a multiomic liver atlas with...
Contineum’s J&J‑partnered MS drug misses key vision endpoint — shares fall
Contineum Therapeutics reported topline results from its Phase II VISTA study of PIPE‑307, an M1 receptor agonist developed with Janssen, and the trial missed its primary and key secondary...
Taiho and Cullinan file rolling NDA: zipalertinib targets EGFR exon‑20 NSCLC
Taiho Pharmaceutical and Cullinan Therapeutics began a rolling New Drug Application filing with the FDA seeking accelerated approval of zipalertinib for patients with locally advanced or...
Abbott to buy Exact Sciences: $23B play for cancer diagnostics
Abbott Laboratories announced a definitive agreement to acquire Exact Sciences for roughly $21–23 billion in cash, moving the med-tech giant directly into cancer screening and precision oncology....
Lilly crosses $1 trillion mark — obesity drugs drive value
Eli Lilly became the first drugmaker to reach a $1 trillion market valuation, a milestone the company attributed to blockbuster revenue from its obesity and metabolic medicines. The firm’s market...
CDC website changes: language suggests vaccines-autism link
The Centers for Disease Control and Prevention revised wording on a vaccine-safety webpage to state that a causal link between childhood vaccines and autism cannot be ruled out. The update follows...
Ginkgo launches Virtual Cell: open pharmacology dataset for AI drug discovery
Ginkgo Bioworks’ Datapoints unit launched the Virtual Cell Pharmacology Initiative (VCPI), an open-source project to generate standardized pharmacology datasets and a reference engineered cell...
Ocean Dx test matches cultures 100% in pilot — sepsis ID in hours
France-based Ocean Diagnostics completed a 110‑patient pilot showing its rapid bloodstream pathogen ID test matched conventional blood culture results at 100% and detected additional pathogens...
Contineum’s PIPE‑307 misses phase 2 endpoints — shares tumble
Contineum Therapeutics reported topline data from its Phase 2 VISTA trial of PIPE-307 in relapsing‑remitting multiple sclerosis and said the study failed to meet primary and key secondary...
GSK and Anaptys in court — billion‑dollar royalties and rights at stake
A legal fight escalated between GSK (via Tesaro) and AnaptysBio over licensing terms tied to the cancer immunotherapy Jemperli. Tesaro filed suit alleging Anaptys breached the 2014 collaboration...
Moderna restructures: $1.5B lifeline and pipeline pruning
Moderna secured a $1.5 billion financing package as part of a plan to reach break‑even by 2028 and to redirect revenue from its seasonal vaccine franchise into oncology and rare disease. At the...
FDA ramps hiring and starts email clarifications to speed reviews
The U.S. Food and Drug Administration announced hiring more than 1,000 staffers to bolster review capacity and launched a pilot communications program letting sponsors send one 'quick...
AI accelerates early drug discovery: Iambic and AI Proteins scale up
Two AI‑driven discovery firms highlighted rapid chemistry‑to‑clinic timelines and fresh capital for protein therapeutics. Iambic reported that physics‑informed algorithms and automation have...
Abbott to buy Exact Sciences: $23 billion diagnostic push
Abbott agreed to acquire Exact Sciences in a cash deal that values the cancer-diagnostics company at roughly $21–23 billion. The transaction combines Abbott’s global diagnostics footprint with...
Bayer’s HER2 drug cleared — Thermo Fisher test approved
The FDA approved Bayer’s oral HER2-directed therapy Hyrnuo (sevabertinib) for adults with locally advanced or metastatic HER2-mutant non-small-cell lung cancer, granting the drug priority review...