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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...
Court blocks 340B rebate pilot: rollout paused before Jan. 1
A federal judge in Maine issued an order blocking the Department of Health and Human Services from implementing the latest 340B drug rebate pilot program ahead of its planned Jan. 1 effective...
Setrusumab phase III flop: Ultragenyx, Mereo shares collapse
Ultragenyx Pharmaceutical and Mereo BioPharma disclosed that late-stage trials of setrusumab failed to meet primary endpoints, prompting a sharp market reaction. Mereo’s stock plunged roughly 90%...
Genmab scraps acasunlimab: Phase 3 program terminated
Genmab announced it is terminating clinical development of acasunlimab, a bispecific antibody that had been advanced in collaboration with BioNTech until that partner exited last year. The company...
China clears Innovent’s ipilimumab: neoadjuvant combo approved
China’s National Medical Products Administration approved Innovent Biologics’ Tabosun (ipilimumab N01, IBI‑310) in combination with sintilimab as a neoadjuvant treatment for stage IIB–III...
FDA clears Diasorin molecular POC: 15‑minute four‑plex wins CLIA waiver
The U.S. Food and Drug Administration granted 510(k) clearance and a CLIA waiver for Diasorin’s four‑plex assay on the Liaison Nes point‑of‑care PCR platform, enabling detection of Flu A/B, RSV...
Adlai Nortye licenses pan‑RAS AN‑9025 to ASK Pharm: China rights secured
Adlai Nortye entered an exclusive licensing agreement with Jiangsu Aosaikang Pharmaceutical (ASK Pharm) granting China rights to AN‑9025, a pan‑RAS(ON) oral small molecule designed to target...
Harbour Biomed, Lannacheng tie up on radionuclide‑drug conjugates
Harbour Biomed and Yantai Lannacheng Biotechnology announced a long‑term strategic collaboration to co‑develop next‑generation radionuclide‑drug conjugates for oncology. The partners said the deal...
In vivo gene therapy momentum... editing tools still racing to catch up
Two pieces this week captured the state of gene‑based medicine: a review noting 2025 as a breakout year for in vivo gene therapies and an industry dispatch on the proliferation of gene‑editing...
Thousands of lytic phages uncovered: virulent phages show persistence
Large‑scale genomic surveys revealed thousands of previously unknown lytic bacteriophages embedded in bacterial genomes, while complementary work found virulent phages capable of long‑term...
New preclinical oncology agents: GAS41 YEATS inhibitor and selective BTK blockers
Researchers disclosed a first‑in‑class GAS41 (YEATS4) inhibitor for non‑small‑cell lung cancer and published selective Bruton tyrosine kinase (BTK) inhibitors that block invasion and progression...