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FDA expands frontline CLL use of noncovalent BTK inhibitor
The FDA approved pirtobrutinib (Jaypirca) for adults with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who do not have del(17p), marking a shift to...
Shionogi doubles down on rare disease with IntraBio deal
Shionogi agreed to acquire IntraBio, paying $2 billion upfront, extending the Japanese company’s rare-disease strategy with a marketed therapy. The Texas-based IntraBio brings Aqneursa, an...
Roche and Alector restart Parkinson’s push with $100M upfront
Roche has signed a deal with Alector that includes a $100 million upfront payment, targeting Alector’s neuroscience and Parkinson’s disease programs. The agreement arrives after another large...
FDA uses manufacturing fixes as trigger for hemophilia A review delay
The FDA extended its review of Novo’s hemophilia A injection denecimig after identifying issues at an unnamed manufacturing facility. The agency attributed the delay to “ongoing facility...
Breye raises Series A to advance oral therapy for diabetic retinopathy
Breye Therapeutics raised €67.5 million (about $75.6 million) in a Series A to push danegaptide, an oral small molecule candidate for non-proliferative diabetic retinopathy (NPDR). The company...
Vaxcyte bets on next-gen pneumococcal vaccine in Phase 3
Vaxcyte said its experimental pneumococcal vaccine VAX-31 met key endpoints in a Phase 3 trial in adults age 50 and older, triggering a sharp stock move reported as a 35% gain. The company...
FDA launches expedited IND pilot to speed early trial entry
The FDA rolled out an expedited Investigational New Drug (IND) pilot program designed to reduce bottlenecks in clinical trial applications. The IND pilot is part of HHS’s effort to onshore...
Swiss clinical trials decline as approvals and data laws slow access
A new analysis finds that drug trial activity in Switzerland fell from 185 in 2014 to 137 in 2024, despite growth in global trial volume, attributing the decline to slow approvals, restrictive...
Trial adherence fades quickly for Medicaid patients on GLP-1 weight-loss drugs
A landmark claims-based study of nearly 4,000 Mississippi Medicaid members found that about half of patients stopped using GLP-1 weight-loss drugs within months. The analysis linked steep...
Bristol Myers faces analyst pressure over pipeline timing risk
A Leerink analyst downgraded Bristol Myers Squibb, shifting its view from outperform to a more bearish stance amid skepticism about upcoming catalysts and pipeline timing. The report cited...
Pneumococcal vaccine Phase 3 win for Vaxcyte
Vaxcyte said its next-generation pneumococcal vaccine, VAX-31, met key endpoints in a Phase 3 trial in adults age 50 and older, setting up a direct push into the crowded market dominated by Pfizer...
Regulatory expansion for Jaypirca in CLL
Lilly’s Jaypirca received a label expansion for use as a first-line therapy in chronic lymphocytic leukemia, marking another step for the BTK/CDK pathway strategy in earlier lines of treatment....
Rare disease dealmaking: Shionogi acquires IntraBio for $2B
Shionogi agreed to acquire IntraBio, a Texas-based rare-disease company, for $2 billion upfront, adding a marketed treatment covering two inherited conditions to its expanding rare disease...
Neuroscience collaboration: Roche pays $100M upfront to Alector
Roche is paying Alector $100 million upfront in a new partnership focused on neuroscience and Parkinson’s disease efforts. The deal arrives amid shifting collaboration dynamics at large biopharma...
Rare kidney and liver rare disease co-development: CSL and Alentis
CSL struck a collaboration with Alentis to co-develop lixudebart, an anti-fibrosis candidate for life-threatening rare kidney and liver diseases, with $355 million paid upfront plus potential...
Funding: maturing diabetic retinopathy pipeline with Breye Series A
Breye Therapeutics raised €67.5 million (about $75.6 million) in a Series A to advance oral danegaptide for non-proliferative diabetic retinopathy (NPDR) into later-stage clinical development. The...
Vaccine and oncology MRD strategy: Signatera-guided trial AFT-70 NAVIGATE
A new global Phase III trial, AFT-70 NAVIGATE, will test whether ultrasensitive Signatera blood MRD monitoring can help spare early breast cancer patients from toxicity by guiding the use of...
Epigenetic cancer biology: irosustat shows oral efficacy in resistant malaria
Researchers reported that irosustat, a steroid sulfatase inhibitor, and its target cholesterol sulfate inhibit drug-resistant Plasmodium falciparum through a host-directed mechanism. In mouse...
Rare ocular biomarker discovery for diabetic eye disease
Researchers identified miR-362-5p as a potential biomarker for diabetic eye disease, reporting elevated levels in diabetic retinopathy that track with disease severity. The study also tied the...
Machine-learning drug R&D: OrganoIDNet tracks CAR T activity in patient tumor organoids
A new approach combines patient-derived pancreatic tumor organoids with a deep learning tracking system, OrganoIDNet, to monitor CAR T cell killing in real time inside living, patient-specific...