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Novartis expands China-origin mRNA T-cell engager deal
Novartis has agreed to pay Abogen Biosciences $575 million upfront for exclusive worldwide rights to ABO2203, an mRNA-encoded CD19xCD3 T-cell engager designed to reset B cells by in vivo...
Phase 3 evERA confirms oral giredestrant plus everolimus survival gain in metastatic breast cancer
Results from the phase 3 evERA Breast Cancer study in the New England Journal of Medicine show that adding giredestrant to the mTOR inhibitor everolimus nearly doubles survival without progression...
Biotech financing: Immix CAR-T offering follows interim NEXICART-2 amyloidosis response
Immix Biopharma moved quickly after an interim readout from its Phase II NEXICART-2 trial for BCMA-targeted CAR-T NXC-201 in light-chain (AL) amyloidosis. Days of investor attention intensified...
Clinical development funding: AnaCardio raises €62.5M for oral AC01 in advanced HFrEF
AnaCardio raised €62.5 million (about $70.5 million) in a Series B to advance AC01, an oral calcium-sensitizing contractile agent targeting chronic advanced heart failure with reduced ejection...
Regulatory science: FDA to highlight aging and longevity in next FARS update
The FDA plans to add aging and longevity to topics highlighted in its updated Focus Areas of Regulatory Science (FARS) report, according to remarks by FDA Chief Scientist Steven Kozlowski at the...
AI in clinical diagnostics: Imagene and CellCarta expand AI pathology CDx partnership for NSCLC
CellCarta and Imagene AI expanded their collaboration to move AI pathology tools into companion diagnostic (CDx) development for non-small cell lung cancer. The partnership focuses on analytical...
Cancer care: targeted therapy regimen delivers 97% event-free survival signal in early-stage Hodgkin lymphoma
A phase 2 trial in early-stage classical Hodgkin lymphoma reported high response and durable disease control with a regimen pairing two targeted drugs alongside a de-escalated chemotherapy...
Bioethics and evidence standards: AI in the operating room faces “evidence not ready” critique
Surgeons say AI tools are entering operating rooms faster than the evidence base for safe, effective use. In a report summarized as AI in the Operating Room coverage, clinicians argue that...
Biopharma funding and platform building: Parakeet Health raises $10M for conversational agentic platform
Parakeet Health secured $10 million in a Series A round for its conversational agentic platform, according to the deal coverage. The round was led by Canvas Ventures, with participation from Blank...
Genetic tool for cancer sampling: “Genetic barcodes” show tumor heterogeneity missed by biopsies
A study concept described as “genetic barcodes” highlights how tumor biopsies can fail to capture the full clonal landscape of breast cancer, given tumors’ patchwork of competing cell populations....
FDA regulatory modernization for clinical trials
The FDA opened a new clinical trial modernization office within CDER, signaling a renewed focus on speeding and updating how trials are designed and executed. The move comes as sponsors and...
AI-powered immunology and drug discovery dealmaking
Novartis struck a large licensing deal with Abogen Biosciences for an mRNA-encoded autoimmune T-cell engager, with the arrangement structured around a large upfront payment and milestone-based...
Cancer immunotherapy pipeline financing
Immix Biopharma announced a follow-on financing after an interim readout for NXC-201, its BCMA-targeted CAR-T program in AL amyloidosis. The company reported an 89% complete response rate among 45...
Biotech startup funding and lead reprioritization
Circle raised $92.5 million to accelerate its cyclin D1 program, advancing the preclinical lead CID-165 ahead of an earlier priority asset. The funding was prompted by deeper breast cancer...
Regulatory scrutiny and trial-failure outcomes in ophthalmology
Aviceda Therapeutics moved to wind down after a Phase 2 failure for its geographic atrophy program, according to a person familiar with the decision. The company had been planning a Phase 3 step...
New clinical trial results in CLL and treatment sequencing questions
Two Phase 3 trials, BRUIN CLL-313 and BRUIN CLL-314, reported results on pirtobrutinib in first-line chronic lymphocytic leukemia, tightening the field around how sequencing may evolve. While...
Heart failure therapeutics funding for late-stage preparation
AnaCardio closed a €62.5 million ($70.5 million) Series B to advance AC01 through Phase 2b development toward Phase 3 readiness. The oral calcium-sensitizing contractile agent is aimed at chronic...
AI pathology collaboration to speed companion diagnostics
CellCarta and Imagene AI expanded an AI pathology partnership aimed at moving biomarker assays into clinical development and companion diagnostic (CDx) pathways. The collaboration covers...
Trade and pharma manufacturing expansion
Bayer detailed plans for a $2.2 billion manufacturing site in New Albany, Ohio, projecting around 600 new jobs. The announcement adds to a broader set of US capacity moves by large pharma and...
US vaccine litigation risk for Pfizer
Florida’s Attorney General filed a lawsuit against Pfizer and CEO Albert Bourla over alleged COVID-19 vaccine marketing practices, including claims that the company misrepresented safety...