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Zanidatamab posts Phase III win in gastroesophageal cancer — filing plans begin
Zymeworks’ HER2‑targeted bispecific zanidatamab (Ziihera) achieved its primary endpoint in the Phase III HERIZON‑GEA‑01 trial, demonstrating significant progression‑free survival (PFS) gains...
Administration mulls sweeping vaccine changes — industry issues private warnings
Reporting shows the Trump administration, guided by Health Secretary Robert F. Kennedy Jr., is considering policy changes that could restrict adjuvant use and reformulate multi‑disease combination...
Iambic, Terray land AI bets — models fuel discovery and candidate selection
Iambic closed a $100 million financing round to advance its Enchant and NeuralPLexer AI platforms, which the company says predict clinical endpoints and protein‑ligand structures to accelerate...
FDA clears ziftomenib (Komzifti) — menin inhibitor approved for NPM1‑mutant AML
The U.S. FDA approved ziftomenib (Komzifti), a selective oral menin inhibitor developed by Kura Oncology and Kyowa Kirin, for relapsed or refractory NPM1‑mutant acute myeloid leukemia (AML) ahead...
DNAe and Ocean Dx push same‑day infectious diagnostics toward clinic use
UK‑based DNA Electronics presented data advancing its LiDia‑SEQ cartridge sequencing platform as a rapid, automated diagnostic for bloodstream infections and cancer, targeting same‑day results...
Big venture vehicles close — fresh capital for early biotech in Europe and US
Sofinnova Partners closed a €750 million (reported $750M) fund to support early‑stage therapeutics, and European investors launched additional sizable vehicles to replenish venture capital for...
Thermo Fisher, Purdue and partners expand hands‑on biomanufacturing capacity and training
Thermo Fisher Scientific opened its East Coast Advanced Therapies Collaboration Center in Philadelphia to support cell and gene therapy development, expanding its national network of ATxCC sites....
J&J pays $3.05B for Halda — adds RIPTAC prostate asset
Johnson & Johnson agreed to acquire Halda Therapeutics for $3.05 billion in cash, securing Halda’s precision oncology pipeline led by the clinical-stage oral candidate HLD-0915. Halda’s lead...
Arrowhead wins FDA approval — prices undercut Ionis
The FDA cleared Arrowhead Pharmaceuticals’ RNA interference therapy Redemplo (plozasiran) for familial chylomicronemia syndrome, marking the company’s first commercial product and the second RNAi...
Roche oral SERD delays recurrence — adjuvant phase III win
Roche reported positive Phase III results for its oral selective estrogen receptor degrader (SERD) giredestrant in the adjuvant setting for estrogen-receptor–positive, HER2-negative early breast...
Xenotransplant ‘encyclopedia’: 61-day pig kidney maps rejection
Researchers published the most comprehensive physiological and multiomic dataset to date from a pig-to-human kidney transplant conducted in a brain-dead recipient, tracking the graft and host...
Trump, RFK Jr. mull vaccine rule changes — manufacturers warn
U.S. health officials under Health Secretary Robert F. Kennedy Jr. have discussed sweeping changes to vaccine policy, including discouraging adjuvants used to boost shot effectiveness and...
Roche, Freenome tie-up and new sequencer — diagnostics push abroad
Roche agreed to a collaboration and licensing deal with Freenome worth potentially more than $200 million to commercialize Freenome’s blood-based cancer screening tests outside the U.S.; Roche...
Nvidia, Sheba, Mount Sinai to build genomic foundation model
Nvidia, Sheba Medical Center’s ARC Innovation and the Icahn School of Medicine at Mount Sinai launched a three‑year collaboration to develop a large language model (genomic Foundation Model, gFM)...
DNAe readies rapid sequencing platform — LiDia‑SEQ commercialization set for 2027
UK diagnostics firm DNA Electronics presented data supporting its LiDia‑SEQ rapid sequencing platform and said it plans commercialization in 2027, targeting same‑day infectious-disease and cancer...
Venture capital surge: Iambic $100M; Solve nets $120M for ADCs
Iambic closed a $100 million financing to accelerate AI drug‑discovery platforms (Enchant and NeuralPLexer) and move cancer candidates toward the clinic; investors include Abingworth and...
NIH cuts halted 383 trials — 74,000 participants affected
A JAMA Internal Medicine analysis found that federal funding cuts led to termination of 383 NIH‑funded clinical trials between late February and mid‑August, disrupting more than 74,000 enrolled...
Administration probes vaccine reform: makers warn of supply shock
U.S. health-policy proposals under the Trump administration and Health Secretary Robert F. Kennedy Jr. are prompting vaccine manufacturers to raise concerns about rapid, wide-ranging changes to...
Roche’s SERD wins in early breast cancer – adjuvant data positive
Roche reported positive Phase 3 data for its oral selective estrogen receptor degrader (SERD) giredestrant in the adjuvant setting for ER-positive, HER2-negative early breast cancer. At a...
Zanidatamab cuts progression in Phase 3 — partners set regulatory push
Zymeworks and Jazz Pharmaceuticals announced positive topline results from the Phase 3 HERIZON-GEA-01 trial evaluating zanidatamab (Ziihera) in first-line HER2-positive gastroesophageal...