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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...
AI‑driven biologics keep drawing cash: Galux and QuantX close rounds
Galux closed a ₩42 billion (US$29 million) Series B to scale AI‑driven antibody design capabilities and move programs into discovery and preclinical optimization. The funding will be used to...
Top medical groups launch independent vaccine review as NIH signals reforms
The American Medical Association and the Vaccine Integrity Project announced a joint initiative to independently review vaccine science and provide clinicians and families with evidence summaries,...
Capsida confirms cerebral edema in halted gene‑therapy trial fatality
Capsida Biotherapeutics said an autopsy found cerebral edema as the cause of death in a participant from its suspended SYNRGY trial testing CAP‑002 for STXBP1 deficiency. The company said...
Diagnostics momentum: Personalis wins Medicare coverage; VolitionRx expands to Japan
Personalis secured Medicare coverage for its NeXT Personal MRD assay for surveillance in stages I–III non‑small cell lung cancer, citing TRACERx consortium evidence and Nature Medicine...
Lilly buys Orna: $2.4bn bet on in vivo CAR‑T
Eli Lilly agreed to acquire Orna Therapeutics in a deal valued at up to $2.4 billion, moving the pharma into in‑vivo CAR‑T and circular RNA delivery. The transaction gives Lilly immediate access...
FDA rejects Regenxbio therapy — rare‑disease program stalled
The FDA issued a complete response letter rejecting Regenxbio’s RGX‑121 for Hunter syndrome, citing concerns about surrogate endpoints, historical controls, and the robustness of the evidence...
Nektar’s rezpeg holds up at 1 year — durability claim strengthens
Nektar Therapeutics reported one‑year follow‑up data showing rezpegaldesleukin sustained and in some cases deepened skin‑clearance responses in patients with moderate‑to‑severe atopic dermatitis....
Evommune’s EVO301 challenges Dupixent — phase II moves market
Evommune reported that EVO301, an IL‑18–binding long‑acting fusion protein, met primary endpoints in a Phase 2a atopic dermatitis study, delivering statistically significant EASI improvements...