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UCB bets on bispecifics: $1.1bn Antengene license
UCB struck a global licensing deal with Antengene to acquire development and commercialization rights to ATG-201, a CD19/CD3 bispecific T‑cell engager for autoimmune diseases. Antengene will run...
FDA surprises PepGen: partial hold on DM1 Phase II
The FDA placed a partial clinical hold on PepGen’s Freedom2 Phase II trial of PGN‑EDODM1 for myotonic dystrophy type 1 (DM1), citing concerns in preclinical pharmacology and toxicology data rather...
Illumina expands genomic alliance: adds proteomics to 50,000 genomes
Illumina announced an expansion of the Alliance for Genomic Discovery by adding 50,000 genomes paired with proteomic data to the consortium dataset. DeCode Genetics will generate the proteomics...
Zealand’s amylin posts phase‑2: tolerability touted by Roche partner
Zealand Pharma released Phase 2 results for petrelintide, an amylin analog partnered with Roche, showing mean weight loss up to 10.7% at 42 weeks and a tolerability profile the partners described...
Oral GLP‑1 era begins: pills arrive as employers get new access pathways
The oral GLP‑1 landscape is shifting: Novo Nordisk rolled out an oral form of its GLP‑1 weight‑loss drug and Eli Lilly’s oral candidate orforglipron nears approval, marking a transition from...
AI liquid biopsy spots liver disease: fragmentomics moves beyond cancer
Researchers at Johns Hopkins unveiled an AI‑driven liquid biopsy that uses genome‑wide cfDNA fragmentation patterns—fragmentomics—to detect liver fibrosis, cirrhosis, and other chronic liver...
FDA pivots on advisory panels and single‑trial defaults… industry asks for clarity
A senior FDA official publicly questioned the role and efficiency of advisory committees, calling some panels 'costly' and 'slow,' while industry groups such as ACRO have urged the agency to...
Atavistik doubles down: Series B extension funds HHT clinical push
Atavistik Bio extended its Series B with an additional $40M, bringing the round to $160M to advance its allosteric programs for blood disorders, including a lead candidate targeting hereditary...
Zorevunersen slashes seizures: gene therapy shows unprecedented Dravet results
Clinical trials led by UCL and Great Ormond Street Hospital reported that zorevunersen, a gene‑regulatory therapy for Dravet syndrome, produced dramatic seizure reductions—between ~59% and 91%...
New immunotherapy routes: CAR‑T for solids and a proteomic target to boost immunogenicity
UCLA researchers reported a next‑generation CAR‑T design engineered to resist solid‑tumor immunosuppression and show activity in preclinical models, addressing a major barrier to CAR‑T efficacy...
Oral GLP-1s Arrive: Pills, approvals and the rebound question
Novo Nordisk pushed the oralization of its GLP-1 platform into the clinic this year with a tablet version of Wegovy and competitors are closing in. Eli Lilly’s oral orforglipron is expected to...
FDA rethinks process: Advisory panels and single-trial default under scrutiny
A senior Food and Drug Administration official questioned longstanding external advisory committee processes as “costly” and slow, signaling an internal push to streamline review procedures....
PepGen hit with partial hold — U.S. sites paused, global program continues
The FDA placed a partial clinical hold on PepGen’s Freedom2‑DM1 Phase II study after re‑examining preclinical toxicology data, pausing U.S. enrollment while permitting work to continue in other...
Illumina expands alliance: Adds 50,000 genomes with paired proteomics
Illumina said it will add 50,000 whole genomes paired with proteomic profiles to the Alliance for Genomic Discovery (AGD), with pharmaceutical partners GSK and Amgen leading the proteomics...
Tenaya taps Alnylam in $1.13B target pact — RNAi joins cardiac discovery
Tenaya Therapeutics signed a discovery collaboration with Alnylam Pharmaceuticals that provides $10 million up front and up to $1.13 billion in milestone payments if up to 15 delivered genetic...
Evo 2: AI model designs genomes across the tree of life
Researchers published Evo 2, a foundation DNA model trained on genomes from over 100,000 species, and demonstrated the model’s ability to identify disease‑causing mutations and design...
Liquid biopsy goes systemic: cfDNA fragmentomics detects liver disease
Johns Hopkins and collaborators expanded cell‑free DNA fragmentomics beyond oncology, showing fragment‑level cfDNA patterns can detect liver fibrosis and cirrhosis and flag chronic disease...
Atavistik raises $160M to push allosteric drugs for blood disorders
Atavistik Bio extended its Series B financing by $40 million, bringing total Series B proceeds to $160 million to support clinical trials of allosteric therapies for hereditary hemorrhagic...
Gene regulation therapy cuts seizures in Dravet: unprecedented clinical results
A gene regulation approach for Dravet syndrome, zorevunersen, produced dramatic seizure reductions and functional gains in pediatric patients in early clinical testing, according to data published...
Moderna to pay up to $2.25B — ends LNP patent saga
Moderna agreed to a settlement that could total up to $2.25 billion with Roivant/Genevant and Arbutus over lipid nanoparticle (LNP) technology used in its COVID-19 vaccines. The deal includes a...