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Immuno-oncology – China regulatory filing for a novel 4-1BB bispecific
China’s NMPA accepted the NDA for opamtistomig (LBL-024), a PD-L1/4-1BB–directed bispecific antibody, for previously treated advanced extrapulmonary neuroendocrine carcinoma (EP-NEC). The Center...
Oncology – early-stage antibody signal in pre-surgery HER2-positive breast cancer
Zanidatamab is showing early promise in a pre-surgical setting for HER2-positive breast cancer, with results from the NeoZanHER phase 2 trial reported in Nature Communications. The study evaluates...
Rare disease & RNA interference – Phase II efficacy for divesiran in polycythemia vera
Silence Therapeutics reported positive Phase II results for divesiran, an siRNA designed for polycythemia vera (PV), a rare blood cancer with burdensome phlebotomy requirements. In the SANRECO...
Drug safety – real-world psychosis signal for subcutaneous foslevodopa/foscarbidopa
A retrospective real-world study is drawing attention to psychotic complications seen during use of subcutaneous foslevodopa/foscarbidopa infusions in Parkinson’s disease. Researchers examined 198...
Neurodegeneration – targeted alpha-synuclein degradation blocks PFF aggregation
A study in npj Parkinson’s Disease reports that selectively degrading alpha-synuclein can block aggregation triggered by preformed fibrils (PFFs). Researchers describe a targeted protein...
Central nervous system tumors – roadmap aims to accelerate trials in rare childhood CNS cancers
A new multi-stakeholder consensus roadmap is pushing to streamline clinical trials for rare childhood CNS tumors, where the traditional bottleneck has been that trial infrastructure struggles to...
Regulatory – Europe recalls Amgen’s Tavneos after marketing authorization cancellation
European regulators have ordered the recall of all batches of Amgen’s Tavneos (avacopan) after the European Commission canceled its marketing authorization earlier this month. The recall action is...
Finance & pipeline operations – Amylyx books $500M ahead of submission after readout
Amylyx is banking $500 million ahead of a planned regulatory submission, according to a finance report described as buoyed by a recent readout. The report frames the financing as supporting the...
Platform & manufacturing – Genentech invests $750M for drug delivery device facility
Genentech is investing $750 million in a new drug delivery device facility at its Hillsboro, Oregon site, with the project expected to come online as operations expand for device-enabled...
AI commercialization – EVERSANA expands AI platform with medical affairs and commercial functions
EVERSANA announced expanded capabilities for its AI-powered commercialization platform, adding medical affairs and commercial workflow automation features. The update includes capabilities for...
Regulatory action in Alzheimer’s diagnostics
The FDA has cleared PrecivityAD2, a blood test intended to help evaluate Alzheimer’s disease by detecting Alzheimer’s-linked amyloid pathology. Developed from technology pioneered at Washington...
Immuno-oncology in China: next-generation 4-1BB agonism
China’s NMPA has accepted the NDA for opamtistomig (LBL-024) as monotherapy in previously treated advanced extrapulmonary neuroendocrine carcinoma. The agency granted priority review, and the...
Oncology drug development: HER2 therapy earlier in the care pathway
NeoZanHER, the phase 2 trial of zanidatamab in early-stage HER2-positive breast cancer, reported promising activity designed to move antibody therapy into the pre-surgery setting. The trial...
Rare disease: siRNA shows strong Phase II signal in polycythemia vera
Silence Therapeutics said its Phase II SANRECO trial met the primary endpoint for divesiran, an siRNA targeting TMPRSS6 in polycythemia vera. The company reported an 88% response rate versus 19%...
Oncology trial signal driving financing: Amylyx banks $500M ahead of submission
Amylyx secured a reported $500 million ahead of its regulatory submission following a buoyed readout, according to a biopharma finance report. The update frames the funding timing as closely tied...
Biotech financing: $66 million for inclusion body myositis program
Abcuro raised $66 million through a Series D to advance ulviprubart for inclusion body myositis, a progressive muscle disorder with no approved therapies in the US. The company said the funding...
AI commercialization: EVERSANA expands an enterprise platform
EVERSANA announced expanded capabilities for its AI-powered commercialization platform, adding medical affairs and commercial functions. The update includes medical information support, MLR...
Regulatory or clinical safety: Europe recalls Amgen’s Tavneos after marketing authorization cancellation
European regulators ordered a recall of all batches of Amgen’s Tavneos (avacopan) after the European Commission formally canceled its marketing authorization earlier in the month. The action...
China clinical pipeline start: Akeso gets clearance for AK-157D1 Phase I
Akeso received clinical trial clearance from China’s NMPA for AK-157D1, enabling initiation of a Phase I study in patients with advanced solid tumors. The clearance allows the company to progress...
Biopharma workforce and operational policy: return-to-office pressures R&D roles
Reports indicate that biopharma companies are using return-to-office requirements and hybrid work mandates to reshape R&D capacity, with employees in some locations facing role exits or relocation...