Get the Daily Brief
Latest Biotech News
Late-stage flop sinks brittle-bone drugmakers — Ultragenyx, Mereo hit
Two late-stage Phase III readouts for setrusumab failed to meet primary endpoints, prompting immediate program and market fallout. Ultragenyx Pharmaceutical Inc. and Mereo BioPharma Group plc...
Genmab ends development of bispecific acasunlimab — program discontinued
Genmab A/S announced it is terminating clinical development of acasunlimab, a bispecific antibody formerly partnered with BioNTech. The Danish developer said it will stop work on the asset after...
China approves Innovent’s ipilimumab combo: neoadjuvant option for MSI‑high colon cancer
China’s National Medical Products Administration approved Innovent Biologics’ Tabosun (ipilimumab N01, IBI-310) in combination with sintilimab as a neoadjuvant treatment for resectable stage...
Diasorin clears path into molecular point‑of‑care — 15‑minute four‑plex wins FDA clearance
The US Food and Drug Administration issued 510(k) clearance and a CLIA waiver for Diasorin’s four‑plex molecular assay on the new LIAISON Nes platform, enabling detection and differentiation of...
Boston biotech Nido Biosciences to wind down after weak Phase II
Nido Biosciences announced it will wind down operations in early 2026 after Phase II data fell short of expectations. The Boston‑area startup said the trial outcomes did not support further...
Pan‑RAS licensing deal sends AN‑9025 rights into China — Adlai Nortye, ASK Pharm transact
Adlai Nortye Ltd. granted Jiangsu Aosaikang Pharmaceutical Co. Ltd. (Ask Pharm) exclusive rights in China to AN‑9025, a pan‑RAS(ON) oral small molecule designed to target multiple RAS mutations...
Harbour Biomed and Lannacheng tie up on radionuclide‑drug conjugates
Harbour Biomed and Yantai Lannacheng Biotechnology announced a strategic, long‑term collaboration to develop next‑generation radionuclide‑drug conjugates (RDCs) for cancer. The alliance combines...
Judge blocks 340B rebate pilot ahead of rollout — program paused
A federal judge in Maine issued an order blocking the implementation of the newest 340B rebate pilot program pending further action, temporarily halting a government effort aimed at changing drug...
Novo Nordisk prices Wegovy pill $299 — direct‑to‑consumer push undercuts Lilly
Novo Nordisk launched direct sales of its newly approved Wegovy oral formulation at $299 per month for cash‑pay customers, positioning the drug below pricing announced or expected from rivals. Eli...
2025 marks in‑vivo gene therapy breakthroughs — industry still hunting final editing tool
2025 delivered notable progress for in‑vivo gene therapies as developers reported improved delivery methods and encouraging preclinical and early clinical data, signaling momentum for one‑time...
Phase III bone drug fails – Ultragenyx and Mereo shares tumble
Two late-stage trials of setrusumab missed primary endpoints and triggered severe market reactions for their developers. Ultragenyx Pharmaceutical and Mereo Biopharma reported Phase III failures...
FDA clears Diasorin molecular point‑of‑care assay – 15‑minute four‑plex
The US Food and Drug Administration issued 510(k) clearance and CLIA waiver for Diasorin’s four‑plex molecular assay on the Liaison Nes platform, enabling point‑of‑care detection of influenza A/B,...
China approves Innovent’s ipilimumab–sintilimab neoadjuvant combo
China’s National Medical Products Administration approved Innovent Biologics’ Tabosun (ipilimumab N01, IBI‑310) in combination with sintilimab as neoadjuvant treatment for stage IIB–III resectable...
Boston‑area startup Nido Bio to wind down after Phase 2 miss
Nido Biosciences announced plans to wind down operations in early 2026 after Phase II clinical data fell short of expectations. The Boston‑area company had been testing a candidate in oncology,...
Genmab ends acasunlimab program after BioNTech exit
Genmab announced termination of clinical development for acasunlimab, a bispecific antibody that had been developed with BioNTech before the partner withdrew last year. Genmab said the decision...
Judge blocks 340B rebate pilot just before Jan. 1 rollout
A federal judge in Maine issued an order blocking implementation of the government's current iteration of the 340B rebate pilot program pending further order. The decision represents a legal...
Twice‑yearly depemokimab appears safe in asthma and nasal‑polyp studies
Clinical data released from trials of depemokimab, an IL‑5–targeting monoclonal antibody, report a favorable safety profile when dosed twice yearly for patients with asthma and chronic...
First‑in‑class GAS41 YEATS inhibitor surfaces for NSCLC
Researchers disclosed a first‑in‑class inhibitor targeting GAS41, the protein product of YEATS4, as a candidate for non‑small‑cell lung cancer where the target is frequently overexpressed....
Harbour Biomed and Lannacheng partner on radionuclide‑drug conjugates
Harbour Biomed announced a long‑term strategic collaboration with Yantai Lannacheng Biotechnology to advance next‑generation radionuclide‑drug conjugates for cancer therapy. The alliance combines...
Adlai Nortye licenses pan‑RAS inhibitor AN‑9025 to Ask Pharm
Adlai Nortye Ltd. granted Jiangsu Aosaikang Pharmaceutical (Ask Pharm) an exclusive license for AN‑9025, a pan‑RAS(ON) oral small molecule designed to target a broad spectrum of RAS mutations...