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Biotech chiefs press FDA for stability as agency rolls out new review hires
Hundreds of biotech CEOs and leaders sent a formal letter to FDA Director Marty Makary urging regulatory predictability and warning that agency volatility threatens U.S. innovation. The industry...
MS setback at Contineum – PIPE‑307 misses primary endpoint
Contineum Therapeutics reported topline Phase II VISTA data showing PIPE‑307 failed to meet its primary and secondary efficacy endpoints in relapsing‑remitting multiple sclerosis, driving a sharp...
New obesity axis: ASO targets miR‑22 while payers and employers probe access
Resalis Therapeutics presented preclinical and early translational data for an antisense oligonucleotide targeting miR‑22 that the company says produces precision, durable weight loss by...
Ginkgo Datapoints launches VCPI: open‑source drive for virtual cell pharmacology
Ginkgo Bioworks’ Datapoints unit unveiled the Virtual Cell Pharmacology Initiative (VCPI), an open‑source effort to standardize virtual cell modeling by generating high‑quality pharmacology data...
Quantum‑Si targets 2026 for Proteus protein sequencer launch
Quantum‑Si announced plans to ship its Proteus protein sequencing platform in late 2026, positioning the instrument as a high‑throughput, single‑molecule protein analysis system that could reshape...
Rapid infectious diagnostics race: Ocean Dx sepsis test and a one‑pot CRISPR assay
Ocean Diagnostics completed a 110‑patient pilot showing its rapid sepsis identification test matched conventional blood culture results at 100% and detected additional pathogens missed by culture;...
GSK and AnaptysBio legal fight escalates – disputes over Jemperli revenue
GSK (Tesaro) and AnaptysBio traded lawsuits over a decade‑old license tied to the cancer immunotherapy Jemperli, with GSK seeking termination or modification of the agreement and Anaptys...
MJFF backs LRRK2 ASO: Scineuro wins $5M to advance Parkinson’s antisense program
Scineuro Pharmaceuticals secured a $5 million Michael J. Fox Foundation grant to accelerate preclinical development of SNP‑614, an LRRK2‑targeting antisense oligonucleotide for Parkinson’s...
Abbott to buy Exact Sciences for $21 billion – Diagnostic play
Abbott announced a definitive agreement to acquire Exact Sciences in a cash deal valued at about $21 billion, marking a major move into cancer screening and precision oncology diagnostics. Exact...
Bayer’s HER2 drug cleared for lung cancer – Companion NGS test also approved
The U.S. FDA approved Bayer’s oral HER2‑directed therapy Hyrnuo (sevabertinib) for adults with advanced HER2‑mutant non‑small‑cell lung cancer after prior systemic therapy. The approval relies on...
Contineum’s MS candidate misses endpoints – Pipeline hit
Contineum Therapeutics reported topline results from its Phase 2 VISTA trial of PIPE‑307 in relapsing‑remitting multiple sclerosis and missed the trial's primary and key secondary endpoints. The...
Ocean Diagnostics’ rapid sepsis test nails pilot results... Plans CE and FDA filings
France‑based Ocean Diagnostics completed a pilot clinical evaluation showing its rapid blood test for sepsis pathogen ID matched conventional blood cultures at 100% and correlated strongly with...
Ginkgo launches Virtual Cell Pharmacology Initiative – 12 billion datapoints target
Ginkgo Datapoints announced the Virtual Cell Pharmacology Initiative (VCPI), an open‑source effort to create standardized virtual cell models for drug discovery. The platform will center on a...
Iambic claims two‑year chemistry‑to‑clinic cycle – AI and automation in action
San Diego‑based Iambic described a physics‑informed AI and automation platform that has accelerated small‑molecule discovery timelines to roughly two years from chemistry to clinic. The company’s...
ASO approach targets obesity at its source – Resalis reveals miR‑22 program
Resalis Therapeutics presented preclinical data on an antisense oligonucleotide (ASO) targeting miR‑22 that the company says induces durable, tissue‑level metabolic changes and healthier weight...
Nurix trims staff as pivotal BTK degrader study launches
Nurix Therapeutics implemented a targeted workforce reduction while initiating the DAYBreak pivotal Phase 2 trial of its BTK degrader bexobrutideg in relapsed/refractory chronic lymphocytic...
GSK and AnaptysBio in court fight over Jemperli revenue and rights
Legal disputes escalated between AnaptysBio and Tesaro (a GSK subsidiary) as both parties filed competing lawsuits over licensing rights and revenue tied to Jemperli. GSK/Tesaro moved to terminate...
Biotech warns of FDA volatility as agency hires staff and pilots new comms
Biotech industry leaders urged FDA Director Marty Makary for regulatory stability in a letter citing survey data that shows broad concern over agency predictability; signatories warned that...
Bayer’s HER2 lung drug cleared: Thermo Fisher companion test OK
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, and Thermo Fisher’s Ion Torrent...
Abbott snaps up Exact Sciences: $21B cancer‑diagnostics push
Abbott agreed to acquire Exact Sciences in a cash deal valuing the diagnostics company at roughly $21–23 billion, moving Abbott decisively into cancer screening and precision oncology. Exact’s...