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Lung cancer deal: AstraZeneca expands EGFR exon 20 franchise
AstraZeneca secured exclusive global rights to Dizal Pharmaceuticals’ marketed lung cancer pill Zegfrovy (sunvozertinib) in a deal valued at up to $1.5 billion, tying the acquisition to an FDA and...
Alzheimer’s tau bet: Biogen’s diranersen posts proof-of-concept
Biogen’s phase 2 Celia trial program for the tau-lowering antisense oligonucleotide diranersen (BIIB-080) cleared a key publication milestone at AAIC 2026, with results presented by Catherine...
FDA transparency: FDA resumes public release of drug rejection letters
The FDA confirmed that a pause on publishing drug rejection letters is lifted, meaning additional rejection documents will be released in coming weeks after the agency halted the practice in...
Cancer immunology and inflammation: Takeda mezagitamab extends beyond platelet count in ITP
Takeda reported new quality-of-life findings for its anti-CD38 antibody mezagitamab (TAK-079) in chronic immune thrombocytopenia (ITP), extending the story beyond platelet restoration. The company...
Cell therapy manufacturing automation: Cellares teams with Sonoma on engineered Treg production
Cellares and Sonoma Biotherapeutics agreed to automate the manufacturing of SBT-77-7101, an engineered regulatory T cell therapy in phase 1 for poly-refractory rheumatoid arthritis. Cellares said...
Biotech funding: Mindrank raises $52M for oral GLP-1 into phase 3
Mindrank AI secured a $52 million Series B to advance MDR-001, an AI-discovered oral small-molecule GLP-1 receptor agonist already in phase 3 trials for obesity in China. The financing is...
Neuropsychiatry drug development: Draig lands $65M Series B for AMPA potentiator DT-101
Draig Therapeutics raised $65 million in an oversubscribed Series B to push DT-101, an AMPA receptor potentiator, through phase 3 trials for major depressive disorder. The Cardiff University...
Biomedical diagnostics: BARDA backs Sapphiros for rapid biothreat testing platform
Sapphiros won a $12.4 million award from HHS BARDA to develop its molecular diagnostics platform for rapid detection of biothreats and emerging infectious diseases. The company plans to use the...
AI drug discovery and manufacturing partnerships: Insilico and Bora sign multi-target alliance
Insilico Medicine and Bora Pharmaceuticals announced a multi-target strategic alliance pairing Insilico’s AI-driven generative discovery capabilities with Bora’s manufacturing depth. The agreement...
Biopharma market access and trial operations: NHGRI-funded screening network begins implementation study
NHGRI launched a five-year Population Genomic Screening Network (PGSN) study to evaluate how genomic screening can be implemented in primary care settings, with an initial $8 million committed for...
Alzheimer’s therapeutics move into Phase 3 after tau-targeting readouts
Biogen’s tau-lowering antisense oligonucleotide diranersen (BIIB-080) drew new attention after presentations of Phase 2 “Celia” data at the Alzheimer’s Association International Conference (AAIC)....
FDA and regulatory transparency: more drug rejection letters and broader policy shifts
The FDA confirmed it is resuming and expanding public releases of drug rejection letters after pausing the practice earlier this year. The move comes as the agency seeks to increase transparency...
Oncology dealmaking: AstraZeneca secures global rights to Dizal’s Zegfrovy
AstraZeneca agreed to pay up to $1.5 billion to acquire exclusive worldwide development and sales rights for Dizal Pharmaceutical’s oral EGFR lung cancer drug Zegfrovy (sunvozertinib). The payment...
Cell therapy manufacturing: Cellares and Sonoma automate engineered Treg production
Cellares and Sonoma Biotherapeutics agreed to automate manufacturing for SBT-77-7101, an engineered regulatory T cell (Treg) therapy in Phase I development for poly-refractory rheumatoid...
Clinical oncology: immune-cell therapy shows durable responses in pediatric brain cancer Phase 1
An early-stage trial published in Nature Medicine reported longer-term cancer-free survival in a subset of children treated with tumor-associated antigen (TAA) T-cell therapy for recurrent...
Emerging therapeutics in metabolic disease: Mindrank raises for oral GLP-1 Phase 3
China’s Mindrank AI raised $52 million in a Series B to advance MDR-001, its AI-discovered oral small-molecule GLP-1 receptor agonist. The program is in Phase III trials for obesity in China, with...
U.S. trial operations and decentralized studies face new burden challenges
A new study examining decentralized clinical trials (DCTs) found that easing patient access can increase operational complexity for sponsors and CROs. Researchers reported higher staff workload,...
Diagnostics: Roche wins CE mark for Cobas hepatitis D test
Roche announced CE marking for its Cobas hepatitis D test and plans to launch in countries that accept the designation. The test is designed to detect and quantify hepatitis D virus RNA using...
U.S. insulin market scrutiny: CVS Caremark settlement with FTC over insulin formulary practices
CVS Caremark reached a settlement with the Federal Trade Commission over an insulin-related dispute involving pharmacy benefit manager (PBM) formulary practices. The agreed terms, disclosed...
Research infrastructure: Utrecht Proteomics Center secures €3.5M for AI-enabled upgrades
Utrecht University’s Netherlands Proteomics Centre (NPC) received a €3.5 million grant from the Dutch Research Council for an LSRI upgrade to modernize proteomics infrastructure. The funding...