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Theravance halts R&D after Phase 3 miss — workforce and strategy slashed
Theravance Biopharma announced a companywide wind‑down of research and development and a 50% workforce reduction after its lead candidate, ampreloxetine, failed a Phase 3 study in neurogenic...
UCB pays up to $1.1B for Antengene TCE — Belgian drugmaker enters bispecific arena
UCB licensed ATG‑201, Antengene’s preclinical CD19/CD3 bispecific T‑cell engager (TCE), in a deal worth up to $1.1 billion to expand into novel T‑cell engager modalities for immune disorders. The...
Liquid biopsy moves beyond cancer: cfDNA fragmentomics flags liver disease
Researchers at Johns Hopkins developed an AI‑driven fragmentomics liquid biopsy that identifies liver fibrosis and cirrhosis from cell‑free DNA fragmentation patterns, demonstrating the approach...
Prime seeks FDA blessing on two‑patient prime‑editing trial: a regulator test case
Prime Medicine reversed course and plans to seek FDA approval for PM359, a prime‑editing therapy for chronic granulomatous disease (CGD), based on outcomes in two treated patients. The company...
FDA rejects Regenxbio’s Hunter submission: controls and surrogate endpoints cited
The FDA issued a complete‑response decision on Regenxbio’s gene therapy for Hunter syndrome (RGX‑121), finding the pivotal program lacked reliable external controls, enrolled a heterogeneous...
GSK doubles down on oligonucleotide and PH assets: siRNA licence plus $950M buy
GSK moved aggressively to bolster its pipeline by licensing two siRNA immunology candidates from Frontier Biotechnologies (up to $1 billion) and acquiring 35Pharma for about $950 million for a...
Next‑gen cell therapies target solid tumors — CAR‑T and oncolytic vectors advance
UCLA researchers reported a next‑generation CAR‑T design engineered to resist the immunosuppressive microenvironment of solid tumors, and Calidi Biotherapeutics disclosed preclinical...
Zorevunersen cuts seizures: UCL–GOSH trials report major gains
Researchers at University College London and Great Ormond Street Hospital reported clinical-trial results showing the investigational gene-regulation therapy zorevunersen produced marked,...
Evo 2: AI models whole genomes — Nature publishes foundation-model claims
Teams publishing in Nature unveiled Evo 2, a DNA foundation model trained on genomic data from over 100,000 species that the authors say can both interpret and generate long-form genomic sequences...
GLP‑1s linked to lower addiction risk and mapped to addiction biology
Two independent studies connected GLP‑1 receptor agonists—drugs developed for diabetes and obesity—with reduced substance-use harms and with mechanistic actions in addiction biology. A large...
Fragmentomics hits liver disease: cfDNA tests flag fibrosis and cirrhosis
Johns Hopkins researchers and collaborators published pilot data showing cell-free DNA fragmentation patterns—the fragmentome—can identify liver disease states including fibrosis and cirrhosis...
UCLA engineers CAR‑T to breach solid tumor defenses
UCLA scientists presented a next-generation CAR‑T cell platform engineered to overcome the immunosuppressive microenvironment characteristic of many solid tumors. The group described modifications...
Moderna settles LNP dispute: up to $2.25 billion resolves long-running patents
Moderna agreed to a settlement with Genevant Sciences and Arbutus Biopharma that could total up to $2.25 billion to resolve patent claims over lipid nanoparticle (LNP) delivery technology used in...
UCB licenses Antengene TCE: $1.1B deal enters autoimmune T‑cell engager race
UCB SA licensed global rights to Antengene’s preclinical CD19×CD3 bispecific T‑cell engager ATG‑201 in a transaction valued at up to $1.1 billion. Antengene will complete initial Phase 1 studies...
Theravance halves staff, ends R&D after Phase 3 failure
Theravance Biopharma announced a major corporate restructuring after its norepinephrine reuptake inhibitor ampreloxetine failed a Phase 3 study in symptomatic neurogenic orthostatic hypotension...
ARPA‑H funds lymphatic repair: Rice and Georgia Tech win multimillion grants
Two ARPA‑H awards advanced regenerative efforts for lymphatic disease. A Rice University team led by Omid Veiseh secured up to $18.2 million to develop the first regenerative therapy for...
Big pharma and academic AI pacts: Merck–Tempus and Vanderbilt–Bertis tie up
Merck expanded a multi‑year collaboration with Tempus to apply Tempus’ de‑identified clinical and molecular datasets and AI tooling to discover precision oncology biomarkers and mechanisms of...
Moderna pays $950M upfront — ends long LNP patent fight
Moderna agreed to a multi‑hundred‑million dollar settlement with Arbutus Biopharma and Roivant/Genevant to resolve long‑running patent litigation over lipid nanoparticle (LNP) delivery technology....
FDA escalates crackdown: 30+ warning letters target compounded GLP‑1s
The U.S. Food and Drug Administration issued more than 30 warning letters to telehealth and compounding firms for marketing compounded GLP‑1 copycats as comparable to approved products, signaling...
UCB bets $1.1B on Antengene’s CD19xCD3 TCE — enters TCE arena
UCB SA struck a licensing agreement with Antengene for ATG‑201, a CD19/CD3 bispecific T‑cell engager (TCE) aimed at autoimmune indications, in a deal valued at up to $1.1 billion plus near‑term...