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Phase III flop — setrusumab fails, Mereo and Ultragenyx hit hard
Two late‑stage clinical failures in brittle‑bone disease sent shockwaves through specialty biotech this week. Ultragenyx Pharmaceutical and Mereo Biopharma reported that Phase III trials of...
NMPA clears Innovent’s ipilimumab: neoadjuvant label for MSI‑H colon cancer
China’s National Medical Products Administration approved Innovent Biologics’ ipilimumab N01 (Tabosun, IBI‑310) in combination with sintilimab as neoadjuvant therapy for stage IIB–III resectable,...
FDA clears Diasorin molecular POC test — 15‑minute, CLIA‑waived four‑plex
The US Food and Drug Administration issued 510(k) clearance and a CLIA waiver for Diasorin’s LIAISON Nes molecular point‑of‑care platform and its four‑plex assay for influenza A/B, RSV and...
Genmab halts acasunlimab — program ends after BioNTech walk‑away
Genmab announced termination of clinical development for acasunlimab, a bispecific antibody that previously had been co‑developed with BioNTech before that partner exited the asset. The company...
Nido Bio to wind down after Phase II miss — Boston startup to shutter
Nido Biosciences announced it will wind down operations in early 2026 after Phase II data fell short of expectations, the company said in a LinkedIn post. The Boston‑area biotech, which had been...
Wegovy pill undercuts Lilly — Novo Nordisk lists direct price at $299
Novo Nordisk said it will sell the newly approved Wegovy oral formulation directly to patients at $299 per month for consumers paying out of pocket, undercutting pricing expectations for Eli...
Adlai Nortye licenses AN‑9025 pan‑RAS to Ask Pharm — China deal
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 diverse RAS mutations. The deal...
Harbour Biomed, Lannacheng form radionuclide‑drug conjugate collaboration
Harbour Biomed and Yantai Lannacheng Biotechnology announced a long‑term strategic collaboration to co‑develop next‑generation radionuclide‑drug conjugates (RDCs) for cancer treatment. The...
First‑in‑class GAS41 (YEATS4) inhibitor surfaces for NSCLC
Researchers disclosed a first‑in‑class inhibitor targeting GAS41 (encoded by YEATS4), a chromatin‑associated protein frequently overexpressed in non‑small‑cell lung cancer (NSCLC). The new...
Gene‑editing tools multiply — in vivo therapies show 2025 momentum
Two industry accounts detailed rapid proliferation of gene‑editing modalities and a banner year for in vivo gene therapies. One piece chronicled the expanding toolkit of editing technologies and...
Brittle-bone drug flops: Ultragenyx and Mereo hit by Phase III failures
Ultragenyx and Mereo reported that two Phase III programs of the monoclonal antibody setrusumab missed primary endpoints, triggering steep market reactions and strategic reassessments. The...
J&J abandons bispecific for atopic dermatitis after phase IIb miss
Johnson & Johnson halted its Phase IIb Duplex-AD trial of bispecific antibody JNJ-95475939 after the study failed to meet the efficacy bar, the company disclosed. J&J had acquired the asset via a...
Genmab cancels acasunlimab program after partner exit and Phase 3 review
Genmab announced termination of clinical development for acasunlimab, a bispecific antibody previously co-developed with BioNTech until BioNTech withdrew last year. The Danish biotech said the...
China clears Innovent’s ipilimumab combo for resectable 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 therapy for stage IIB–III resectable...
Diasorin wins FDA 510(k) and CLIA waiver for four‑plex molecular POC assay
Diasorin secured FDA 510(k) clearance and a CLIA waiver for its four‑plex PCR assay on the Liaison Nes point‑of‑care platform, the company announced. The test detects and differentiates influenza...
Judge halts 340B rebate pilot — legal win for drugmakers ahead of Jan. 1 rollout
A federal judge in Maine issued an order blocking the implementation of the government's 340B drug‑pricing rebate pilot 'pending further order,' court filings show. The decision represents a legal...
Nido Biosciences to wind down after underwhelming Phase 2 data
Boston‑area startup Nido Biosciences announced it will wind down operations in early 2026 after Phase 2 data failed to meet expectations, the company stated on LinkedIn. The decision signals an...
Depemokimab shows twice‑yearly dosing safety in asthma and nasal polyps
Clinical trial results indicate depemokimab, an IL‑5 monoclonal antibody, is safe when administered twice yearly in patients with moderate‑to‑severe eosinophilic asthma and chronic rhinosinusitis...
Adlai Nortye licenses pan‑RAS AN‑9025 to Ask Pharm — China rights deal follows
Adlai Nortye entered an exclusive licensing agreement with Jiangsu Aosaikang Pharmaceutical (Ask Pharm) for AN‑9025, a pan‑RAS(ON) oral small molecule designed to target multiple RAS mutations...
Phage ecology reshaped: massive lytic phage trove and persistent virulent phages discovered
Two large studies altered the understanding of bacteriophage diversity and persistence: a broad genomic analysis uncovered thousands of previously unknown lytic phages embedded in bacterial...