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Aviceda Therapeutics winds down after Phase 2 miss
Aviceda Therapeutics is in the process of winding down after a Phase 2 setback left it without a clear path forward for its planned progression of an eye-drug program. The decision reflects how...
FDA regulatory science flags aging and longevity for next FARS update
The FDA signaled a shift in its regulatory science agenda by planning to include aging and longevity among the topics highlighted in an updated Focus Areas of Regulatory Science (FARS) report....
Clinical trial funding and modernization: FDA opens CDER trial modernization office
The FDA opened a new office within CDER focused on modernizing clinical trials as the agency pursues faster and more adaptable study designs. The initiative aligns with FDA’s broader efforts to...
FDA safety scrutiny expands in biologics database after hair-loss signal
A new signal surfaced in an FDA database linking hair loss to biologic drugs, intensifying safety scrutiny around effects that may not appear frequently in controlled trials. The report notes that...
Deal momentum: Novartis expands in vivo autoimmune T-cell targeting with Abogen
Novartis moved to deepen its autoimmune pipeline with a major deal tied to Abogen’s in vivo engineered T-cell engager approach. The reported transaction structure includes a $7.8B agreement for...
Funding: Circle raises $92.5M to move cyclin D1 program ahead
Circle secured a $92.5M funding round that positions its cyclin D1 program ahead of the clinical lead. The funding is connected to preclinical combination data supporting prioritization of CID-165...
Oncology pipeline reads: Immix interim data drives $125M offering
Immix Biopharma announced a $125M offering immediately after an interim readout from its Phase 2 NEXICART-2 trial. The company reported that its BCMA-targeted CAR-T NXC-201 achieved an 89%...
Cancer innovation: stealth cancer vaccine approach using camouflaged nanoparticles
A cancer vaccine strategy highlighted the use of camouflaged nanoparticles aimed at overcoming delivery and antigen stability barriers. The approach targets recurring limitations with free peptide...
Hematology trial landscape: pirtobrutinib sequence debate in CLL
Two Phase 3 CLL trials—BRUIN CLL-313 and BRUIN CLL-314—were published after December 2025 results, placing chronic lymphocytic leukemia at a clinical and regulatory crossroads. The report...
Clinical evidence: GLP-1 weight-loss discontinuation triggers NIH-backed study
NIH funded a $4 million, five-year study at UTHealth Houston to investigate why weight returns after stopping GLP-1 receptor agonist therapy. The project is led by principal investigator Absalon...
Autoimmune RNA therapeutics scaled by big pharma dealmaking
Novartis struck a major licensing partnership with Abogen Biosciences for its mRNA-encoded autoimmune therapy ABO2203, escalating the race to in vivo immune reset approaches. The agreement is...
Biotech funding: AnaCardio advances an oral heart-failure candidate into Phase IIb
AnaCardio raised €62.5 million ($70.5 million) to drive AC01 into Phase IIb development for chronic advanced heart failure with reduced ejection fraction (HFrEF). The Stockholm-based company’s...
Clinical oncology: Giredestrant plus everolimus extends survival in metastatic breast cancer
A phase 3 study in metastatic breast cancer reported that adding giredestrant to everolimus nearly doubles progression-free outcomes in patients, according to results from the evERA trial. The New...
Regulatory and innovation policy: FDA signals aging and longevity as FARS focus
FDA’s chief scientist said the agency plans to add aging and longevity medicine to its planned update of the Focus Areas of Regulatory Science (FARS) report. Steven Kozlowski, MD, said the updated...
Biopharma deal pipeline: AI pathology partnerships for NSCLC companion diagnostics
CellCarta and Imagene AI expanded collaboration to support AI-powered biomarker and companion diagnostic (CDx) development, focusing on non-small cell lung cancer (NSCLC). The partnership aims to...
Federal funding environment: NIH issues fewer grant awards amid process opacity
An analysis reported by STAT says NIH issued 60,924 grant awards in fiscal year 2026 through September 24—its lowest level in six years at the same point in the fiscal calendar. The gap is about...
Biopharma pipeline failure: Aviceda to shut down after Phase 2 setback
Aviceda Therapeutics is winding down operations after a Phase 2 failure, according to a source familiar with the decision. The biotech had planned to advance an eye drug into Phase 3 despite the...
Imaging innovation: PET-based metabolic scoring improves lymphoma risk stratification
A retrospective real-world study from China suggests that a PET-based metabolic score may outperform a standard risk model in diffuse large B-cell lymphoma (DLBCL). The analysis focused on whether...
CAR-T manufacturing economics: convergence on syn/engineering for persistence and immune effects
A study reported in the Journal of Advanced Research described lipid nanoparticle CAR engineering designed to create synergy between T cells and macrophages against leukemia. The preclinical work...
Clinical pain and anxiety care: randomized trial supports intranasal sedative spray in children
A randomized trial found that a nose-friendly sedative spray calmed pediatric patients faster than a repurposed injectable approach prior to procedures. The study evaluated preoperative anxiety...