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Clinical phase 3 momentum in IgA nephropathy
Roche reported that its investigational antisense therapy sefaxersen met phase 3 endpoints in IgA nephropathy, renewing momentum in a kidney market that has expanded rapidly since the first...
Phase 3 win in FUS-ALS with antisense therapy
Otsuka and Ionis reported positive phase 3 results from the Fusion study of ulefnersen in FUS-associated ALS, a rare genetic subtype with no approved targeted therapy. The companies said the data...
Big Pharma betting on AI splicing platform
Boehringer Ingelheim expanded its strategic push into RNA splicing science by striking a deal worth up to $1 billion with Envisagenics. The collaboration targets precision oncology approaches for...
AI drug discovery startup locks in major Series E funding
Enveda Biosciences raised $311 million in a Series E financing to advance multiple nature-derived, AI-designed drug candidates through clinical development. The round supports continued platform...
Platform partnership to link patient biology with 3D pancreatic cancer models
Genialis and Inventia Life Science moved their pancreatic cancer modeling work from concept to infrastructure by launching a collaboration that links patient biology with 3D PDAC models. The...
Med-tech collaboration expands across drug development lifecycle
Syngene expanded its long-running strategic relationship with Bristol Myers Squibb through 2035, extending integrated drug development and manufacturing services across the full pipeline...
FDA IND clearance for Systimmune’s immunotherapy bispecific
Systimmune said the FDA cleared its IND application for SI-B037, a bispecific antibody targeting immunosuppression and other synergistic mechanisms. The company characterized SI-B037 as designed...
CGT collaboration shifts toward shared infrastructure
A new push within the cell and gene therapy (CGT) ecosystem is reframing scale-up as a collaboration and systems problem rather than only a manufacturing capacity issue. Act for Hope, a member-led...
AI cell therapy design startup raises Series C
Basecamp Research raised an oversubscribed $140 million Series C to train its EDEN biological foundation model and apply it to in vivo cell therapy design. The company is positioning EDEN as a...
Phase 3 wins reshape IgA nephropathy competition with mRNA-targeted assets
Roche reported positive Phase 3 data for sefaxersen (formerly IONIS-FB-LRx) in primary IgA nephropathy, meeting endpoints in the Imagination study. The self-administered, once-monthly injection...
Otsuka and Ionis score Phase 3 win in FUS-ALS, pushing for expedited regulator talks
Otsuka Pharmaceutical and Ionis Pharmaceuticals reported positive Phase 3 results from the Fusion study of ulefnersen in patients with FUS-associated amyotrophic lateral sclerosis. The antisense...
Amgen’s Sjögren’s therapy hits Phase 3 objectives after Horizon acquisition
Amgen announced preliminary Phase 3 results showing dazodalibep met key efficacy goals in Sjögren’s disease, a common autoimmune condition with no approved targeted therapy. The fusion protein,...
AI drugmakers accelerate with megafunding rounds and deeper clinical pipeline commitments
Enveda Biosciences raised $311 million in a Series E to fund advancement of an AI-driven pipeline with three oral candidates in human testing. The Nature-derived and microbe-derived chemistry...
Radiopharma consolidation and isotope supply control moves to center stage
Telix agreed to acquire ITM Isotope Technologies Munich in a deal valued at up to $2.35 billion, with an $1.65 billion upfront component. Telix framed the transaction as a way to strengthen...
IND clearances and platform advances push next-generation T-cell engagers toward first-in-human trials
Systimmune received FDA IND clearance for SI-B037, a bispecific antibody designed to target immunosuppression and additional synergistic mechanisms. The clearance puts the program on track for...
Process innovation targets higher productivity and cost control in biologics manufacturing
Sartorius researchers described a multi-controller nonlinear model predictive control system designed for continuous CHO perfusion. In experiments supported by digital twin modeling, the approach...
U.S. FDA adviser scrutiny hits Grail multi-cancer blood test effectiveness questions
An FDA advisory committee session raised questions about the effectiveness of Grail’s next-generation sequencing blood test for early detection of multiple cancers in adults over 50. FDA’s...
Cybersecurity and AI validation concerns surface in clinical deployment risk
A new analysis argues that AI systems can fail in ways that are not captured by aggregate benchmark accuracy, and that hidden risks appear in model behavior when deployed in real workflows....
Digital health and clinical infrastructure: MHRA warns eHR gaps can sink UK trial participation
The UK Medicines and Healthcare products Regulatory Agency (MHRA) warned that inadequate electronic health record systems are costing hospitals eligibility for clinical trials. The regulator said...
Enveda mega-round drives AI-native pipeline into later-stage development
Enveda secured a $311 million Series E to advance its AI-driven drug discovery pipeline, the company said, with a stated focus on moving three oral candidates in clinical trials toward later-stage...