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Medicare expands coverage: Personalis MRD test cleared for lung‑cancer surveillance
CMS granted coverage for Personalis’ NeXT Personal MRD assay to monitor stages I–III non‑small cell lung cancer in the surveillance setting, the company announced. The decision follows clinical...
Takeda taps Iambic AI: $1.7B pact to accelerate small‑molecule discovery
Takeda signed a multiyear, up‑to‑$1.7 billion collaboration with Iambic Therapeutics to deploy Iambic’s AI discovery platform across oncology, GI and inflammation targets. The deal pairs Takeda’s...
Generate Biomedicines files IPO as Phase III asthma program advances
Generate Biomedicines filed for an initial public offering days after dosing its first patient in Phase III studies for GB‑0895, an AI‑designed anti‑TSLP antibody for severe asthma. The company...
NIH director Bhattacharya outlines grant and funding overhaul
NIH Director Jay Bhattacharya announced plans to reform grant review and institutional funding, emphasizing streamlined peer review with fewer key questions, a push to fund higher‑risk research,...
Atopic dermatitis... New biologics dent Dupixent's lead
Evommune and Nektar released clinical data showing prolonged and meaningful skin improvements in patients with moderate-to-severe atopic dermatitis. Evommune reported that EVO301, an IL-18–binding...
Lilly buys Orna – in vivo CAR‑T race accelerates
Eli Lilly agreed to acquire Orna Therapeutics in a deal worth up to $2.4 billion to secure Orna’s circular RNA platform and an in‑vivo CAR‑T candidate, ORN‑252. Orna’s technology pairs engineered...
FDA issues CRL to Regenxbio – gene therapy setback deepens
Regenxbio received a complete response letter (CRL) from the U.S. Food and Drug Administration for RGX‑121, its gene therapy for Hunter syndrome (MPS II), and the agency has placed related...
Moderna’s flu shot spat with FDA: review refused
Moderna said the FDA refused to file (refuse‑to‑file) its application for an mRNA influenza vaccine, citing trial design issues centered on the comparator used in the pivotal study rather than...
Regulatory tug‑of‑war: accelerated approvals collide with CRLs
Industry and clinicians are contesting a sharper FDA posture on accelerated approvals and post‑market expectations. BioCentury flagged tensions between the agency’s accelerated approval messaging...
Takeda bets big on AI: $1.7B pact with Iambic
Takeda signed a multiyear, high‑value discovery pact with Iambic Therapeutics to apply AI tools to small‑molecule drug discovery across oncology, GI and inflammation targets. The agreement, valued...
Money flow: record January financings and AI‑designed drug IPO
Biopharma financings surged to $10.79 billion in January 2026, nearly matching the January 2024 record and signaling investor appetite at the start of the year. The monthly haul reflected a mix of...
AI agents and VerifAI... regulators and sites adopt automation
Regulatory agencies and trial‑tech vendors demonstrated pilot programs using AI to automate repetitive checks and surface critical issues. European regulator BfArM and LORENZ showcased VerifAI...
Spatial omics: quality control tools and national platforms emerge
Researchers released ovrlpy, a quality‑control software that detects overlapping cell signals and tissue folds in spatial transcriptomics datasets, addressing a previously underrecognized source...
Oral MS drugs... fenebrutinib posts wins at phase III and ACTRIMS
Two late‑stage reads sharpen competition in multiple sclerosis. Genentech signaled plans to file an NDA after fenebrutinib produced a phase III noninferiority win against ocrelizumab (Ocrevus) in...
FDA refuses to file Moderna’s mRNA flu shot: agency flags trial control
The FDA issued a refusal-to-file letter for Moderna’s mRNA influenza application, citing concerns over the vaccine’s pivotal trial design rather than explicit safety or efficacy problems. Moderna...
FDA issues complete response letters to Regenxbio—gene therapy pathway questioned
The FDA issued a complete response letter (CRL) for Regenxbio’s RGX‑121 gene therapy for Hunter syndrome, saying the submission did not convince reviewers on efficacy measures and relied on...
Eczema drugs deliver: Evommune and Nektar post winning mid‑stage data
Evommune reported Phase 2a results for EVO301 that met the trial’s primary endpoint, producing substantial EASI score improvements versus placebo and prompting a sharp rise in the company’s...
Lilly buys Orna: $2.4bn push into in‑vivo CAR‑T and circular RNA
Eli Lilly agreed to acquire Orna Therapeutics for up to $2.4 billion to secure the company’s circular RNA platform and in‑vivo CAR‑T programs. Lilly said Orna’s ORN‑252, a CD19‑targeting in‑vivo...
Takeda bets big on AI: multiyear discovery pact with Iambic valued at $1.7bn
Takeda signed a multiyear drug‑discovery agreement valued at roughly $1.7 billion with Iambic Therapeutics to apply AI‑driven discovery tools across oncology, GI and inflammation targets. The deal...
Capital flows: ILiAD’s $115M and Generate Biomedicines’ IPO push
ILiAD Biotechnologies closed an oversubscribed $115 million Series B to accelerate its whooping cough vaccine programs toward pivotal trials and Phase 3 accrual. The financing aims to fund...