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FDA clears menin inhibitor Komzifti — early approval for NPM1 AML
The FDA approved ziftomenib (Komzifti), an oral selective menin inhibitor developed by Kura Oncology and Kyowa Kirin, for treatment of relapsed or refractory (r/r) NPM1‑mutant acute myeloid...
Novo Nordisk readies Alzheimer verdict — semaglutide results due
Novo Nordisk is expected to announce key readouts from ambitious semaglutide studies testing whether the GLP‑1 agonist can slow Alzheimer’s disease progression. The company has flagged these...
White House vaccine shakeup — manufacturers warn of supply and schedule risk
U.S. vaccine manufacturers have privately warned federal officials that proposed changes under Health Secretary Robert F. Kennedy Jr.’s leadership—such as discouraging or banning certain adjuvants...
Nordic Capital buys Evosep — proteomics scales toward clinical markets
Private equity firm Nordic Capital acquired an 80% stake in Danish proteomics company Evosep to accelerate the company’s shift from research workflows into translational and clinical markets....
Nvidia, Sheba, Mount Sinai partner on genomic AI engine — gFM push
Nvidia, Sheba Medical Center’s ARC Innovation, and Mount Sinai’s Icahn School formed a three‑year collaboration to build a Genomic Foundation Model (gFM) — an LLM‑based platform designed to map...
J&J buys Halda for $3.05B — gains RIPTAC prostate drug and platform
Johnson & Johnson agreed to acquire Halda Therapeutics for $3.05 billion in cash, adding Halda’s clinical‑stage RIPTAC platform and lead candidate HLD‑0915 to J&J’s oncology roster. Halda reported...
Arrowhead wins FDA OK for RNAi drug — rivals brace for price fight
Arrowhead Pharmaceuticals secured FDA approval for its RNA‑interference therapy plozasiran (Redemplo) for familial chylomicronemia syndrome, making Arrowhead a commercial‑stage RNAi company after...
Roche’s oral SERD hits primary goal — adjuvant breast‑cancer stakes rise
Roche reported positive Phase III results for giredestrant in the adjuvant setting, showing a statistically significant improvement in invasive disease‑free survival versus standard endocrine...
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...