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Lung cancer label expansion and global rights deal
AstraZeneca secured exclusive global development and commercial rights to Dizal Pharmaceutical’s marketed EGFR exon 20 insertion lung cancer drug Zegfrovy (sunvozertinib) in a deal valued at up to...
Alzheimer’s tau antisense data drive phase-3 momentum
Biogen’s tau-lowering antisense oligonucleotide diranersen (BIIB-080) showed cognitive and biomarker signals in the phase II Celia trial presented during AAIC 2026, supporting Biogen’s decision to...
Cell therapy approvals: allogeneic Treg modality enters the market
FDA’s June approvals included Orca-T (Tregzi), the first approved allogeneic Treg-based cell therapy in matched-donor hematopoietic stem cell transplantation for hematologic malignancies. The...
Biotech IPO and public-market pipeline restart
Attovia Therapeutics filed for an initial public offering after the count of biotechs in IPO preparation reportedly rose to three. The listing momentum reflects a renewed window for public-market...
New biothreat diagnostics funded by BARDA
Sapphiros won a $12.4 million Biomedical Advanced Research and Development Authority (BARDA) award to expand a molecular diagnostics platform for rapid detection of biothreat pathogens in...
AI-assisted drug discovery scales via strategic manufacturing partner
Insilico Medicine and Bora Pharmaceuticals announced a multi-target strategic alliance pairing Insilico’s generative AI discovery capabilities with Bora’s global pharmaceutical manufacturing...
Regulatory and manufacturing: FDA streamlines distributed establishment registration
The FDA proposed a rule to streamline drug establishment registration for distributed manufacturing networks operating under a hub-and-spoke model. If finalized, distributed manufacturing...
Immunology platform automation for engineered Treg manufacturing
Cellares and Sonoma Biotherapeutics agreed to automate the manufacturing of SBT-77-7101, an engineered regulatory T cell therapy in phase I for poly-refractory rheumatoid arthritis. Cellares will...
Oncology diagnostics: UKCA-marked MRD recurrence monitoring
Personalis received UKCA marking for its NeXT Personal Dx MRD assay, expanding clinical use across England, Wales, and Scotland. The company partnered with Link Medical Solutions to support...
Funding: Mindrank advances oral GLP-1 into Phase 3
Mindrank AI raised $52 million in a Series B round to advance MDR-001, its AI-discovered oral small-molecule GLP-1 receptor agonist in phase III development for obesity in China. The financing...
AstraZeneca expands EGFR lung cancer franchise via Dizal rights deal
AstraZeneca agreed to pay Dizal Pharmaceutical up to $1.5 billion for exclusive global rights to develop and commercialize Zegfrovy (sunvozertinib). The deal secures AZ’s role in a targeted EGFR...
Biogen pushes diranersen into Phase 3 after Celia tau-oligo readout
Biogen’s tau-lowering antisense oligonucleotide diranersen (BIIB-080) cleared another hurdle at Alzheimer’s Association International Conference after new published analysis of Phase II “Celia”...
FDA adds Treg cell therapy to June approvals, signaling maturation of allogeneic immune-cell platforms
The FDA’s June approvals included Orca-T (Tregzi), an allogeneic regulatory T cell therapy designed for patients with hematological malignancies undergoing matched-donor hematopoietic stem cell...
AI-enabled drug discovery expands with Insilico and Bora manufacturing partner alliance
Insilico Medicine and Bora Pharmaceuticals announced a multi-target strategic alliance pairing Insilico’s generative AI discovery capabilities with Bora’s pharmaceutical manufacturing and...
A $400M Series C doubles down on Chai’s AI molecule-design engine
Chai Discovery raised $400 million in a Series C, tripling the startup’s valuation versus its prior round and fueling its AI-generated drug discovery platform. The funding highlights continued...
Drugmakers shift factory registration—FDA proposes hub-and-spoke distributed manufacturing rule
The FDA proposed a rule to streamline establishment registration for distributed manufacturing networks using a hub-and-spoke model. Under the proposal, multiple equivalent manufacturing units...
Cell therapy manufacturing upgrades: Cellares and Sonoma automate engineered Treg production
Cellares and Sonoma Biotherapeutics agreed to automate manufacturing of SonomaBio’s engineered regulatory T cell therapy, SBT-77-7101 (currently in Phase I for poly-refractory rheumatoid arthritis...
BARDA awards $12.4M for Sapphiros point-of-care biothreat diagnostics
Sapphiros received a $12.4 million Biomedical Advanced Research and Development Authority (BARDA) award to develop its molecular diagnostics platform for rapid detection of biothreat pathogens in...
Q32’s bempikibart posts another positive Phase 2 update in alopecia areata
Q32 Bio reported favorable Phase 2 results for bempikibart (bemp i), an anti–IL-7Rα antibody, in severe alopecia areata. In Part B of the SIGNAL-AA trial, the company said the primary efficacy...
FDA policy: transparency around drug rejection letters resumes after April pause
The FDA confirmed it is resuming its plan to publish drug rejection letters after pausing the policy in April. The move adds transparency pressure on drug applications and could affect how...