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Nephrology: telitacicept posts strong Phase 3 kidney outcome in IgA nephropathy
RemeGen’s telitacicept produced a markedly larger reduction in proteinuria versus placebo in a prespecified interim analysis of its Phase 3 IgA nephropathy trial. In NEJM-published results,...
Neurodegeneration biology: metabolic stress drives mitochondrial ferroptosis in Parkinson’s
A study linked metabolic stress to worsening Parkinson’s disease pathology through mitochondrial dysfunction and ferroptosis, pointing to a mechanistic bridge between cellular energetics and...
Oncology development: perioperative pembrolizumab plus lenvatinib generates Phase 2 signal in mucosal melanoma
Investigators reported Phase 2 peri-operative results for pembrolizumab combined with lenvatinib in mucosal melanoma, a setting with limited effective options. The study, led by Mao, Lai, Zheng...
Gene therapy safety: rare AAV integration case prompts longer-term scrutiny
Researchers at Children’s Hospital of Philadelphia (CHOP) described a rare brain tumor case linked to adeno-associated virus (AAV) integration after intracisternal magna vector delivery for an...
Cell therapy framework: in-vivo CAR platform funding expands
Create Medicines raised $122 million in a Series B round to advance its in vivo CAR therapies, spanning autoimmune disease and oncology. The company’s approach uses an mRNA-LNP platform to...
Enterprise diagnostics: ARUP launches a public infectious-disease testing dashboard
ARUP Laboratories launched a public-facing dashboard tracking weekly positive results for selected infectious disease assays, aiming to provide earlier visibility into regional trends. The...
AI and automation: IKS Health buys ARAI to strengthen healthcare AI stack
IKS Health acquired ARAI, a healthcare AI startup, to build out the technology behind its automation tools and reduce reliance on third-party AI models. The acquisition targets deeper control over...
Regulatory leadership: CDER chief expected to leave FDA after Makary exit
Reuters reported that FDA CDER chief Tracy Beth Høeg is expected to depart the agency following Commissioner Marty Makary’s resignation. Høeg previously became acting CDER director after Richard...
FDA precision oncology approval using ctDNA MRD testing
The FDA approved atezolizumab (Tecentriq) and Tecentriq Hybreza as adjuvant therapy for muscle-invasive bladder cancer patients with circulating tumor DNA (ctDNA) after cystectomy, using Natera’s...
Late-stage renal trial update for IgA nephropathy
RemeGen’s telitacicept met its primary endpoint in a prespecified interim analysis of a Phase 3 trial in biopsy-proven IgA nephropathy with persistent proteinuria. At week 39, patients on...
Aardvark Therapeutics clinical hold after cardiovascular concern
The FDA placed Aardvark Therapeutics’ program for Prader-Willi syndrome under full clinical hold, stopping all tests of its small-molecule candidate ARD-101. The hold follows a prior trial pause...
Create Medicines expands funding for in vivo CAR platform
Create Medicines secured a $122 million Series B to advance its in vivo immune programming platform for autoimmune disease and oncology. The funding supports pipeline progression across...
Boehringer secures preclinical antibody rights from Immunitas
Boehringer Ingelheim signed a global deal for a preclinical antibody program from Immunitas Therapeutics, targeting chronic inflammatory and autoimmune diseases. The agreement gives Boehringer...
Cell and gene therapy policy: marketplace to relaunch abandoned programs
ASGCT and the Orphan Therapeutics Accelerator launched CGTxchange, an AI-enhanced clearinghouse and marketplace intended to reactivate cell and gene therapy programs that have been shelved despite...
Oncology biomarker research: MYC’s role in tumor DNA repair
Oregon Health & Science University researchers reported a previously unrecognized role for MYC in DNA repair processes that cancer cells use to survive genotoxic stress. The findings link the...
Gene therapy safety signal: AAV integration case tied to brain tumor
A Children’s Hospital of Philadelphia team reported a case of neuroepithelial tumor linked to rare adeno-associated virus (AAV) integration following intracisternal magna vector delivery for an...
Gene editing preclinical therapy: base editing halts prion protein production
Researchers described base editing strategies for prion disease at the 2026 American Society of Gene and Cell Therapy meeting, building on a Nature Medicine paper. Using cytosine base editors to...
US regulatory leadership: CDER chief Høeg expected to exit after Makary
Reuters reported that Tracy Beth Høeg, the FDA’s Center for Drug Evaluation and Research (CDER) chief, is expected to leave the agency following Commissioner Marty Makary’s resignation. Høeg...
ctDNA MRD-guided immunotherapy approval in bladder cancer
The FDA approved Genentech’s Tecentriq (atezolizumab) and Tecentriq Hybreza as adjuvant treatment for muscle-invasive bladder cancer patients who are circulating tumor DNA (ctDNA)-positive after...
Phase 3 progress for telitacicept in IgA nephropathy
RemeGen’s telitacicept delivered a statistically significant reduction in proteinuria in a prespecified interim analysis of a Phase 3 trial in biopsy-proven IgA nephropathy. In patients at high...