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FDA leadership shake-up
Marty Makary resigned as FDA commissioner, with Kyle Diamantas stepping in as acting commissioner, according to multiple reports. The leadership change closes a tenure marked by rapid...
Regulatory change: gene therapy definition in the UK
The UK’s MHRA opened a consultation proposing updates to the legal definition of gene therapies, aiming to reflect technological and manufacturing advances over the past two decades. The move...
Gene therapy safety investigation—death in trial
Capsida Biotherapeutics said it still lacks answers in its investigation into a child’s death in its CAP-002 gene therapy trial last September. The company said its efforts have been stymied...
Alzheimer’s diagnostics in Europe
Roche secured CE marking for its Elecsys plasma phosphorylated-tau 217 blood test to rule in and rule out amyloid pathology. The test, developed with Eli Lilly, adds another non-invasive option...
Oncology precision therapy trial readout with regulator fast-track
The MYTHIC trial showed activity for lunresertib plus zedoresertib in platinum-resistant ovarian cancer, with dosing at the potential recommended phase 2 dose reaching a 50% overall response rate...
Gene therapy platform—AAV redosing and clinical pathway
Kyverna Therapeutics started a rolling submission to the FDA for its miv-cel autoimmune CAR-T candidate, while conducting additional natural history analysis after the agency requested more data....
Clinical oncology cell therapy via CRISPR stem-cell transplant
A Phase I/II multicenter trial reported that CRISPR-Cas9 CD33-deleted allogeneic hematopoietic cell transplantation, paired with gemtuzumab ozogamicin maintenance, achieved engraftment by day 28...
Biotech legal—spatial biology patent settlement
10x Genomics and Curio Bioscience said they reached an agreement in principle to resolve their spatial biology patent infringement litigation, prompting cancellation of a scheduled jury trial. The...
Big pharma and China collaboration deal
Bristol Myers Squibb and Hengrui Pharma have agreed to a broad global drug-discovery pact spanning 13 programs across oncology, hematology and immunology, with BMS paying $600 million upfront. The...
FDA commissioner exit amid regulatory uncertainty
FDA Commissioner Marty Makary has resigned, with Kyle Diamantas, the agency’s top food official, stepping in as acting commissioner. The change ends Makary’s tenure that began in late 2024 and...
FDA gene therapy review path for autoimmune CAR-T
Kyverna Therapeutics has begun a rolling submission to the FDA for miv-cel, after the agency requested additional natural history analysis. The company said the added work is intended to support...
Precision diagnostics: liquid biopsy for tumor microenvironment and ICI response
LiquidCell Dx is developing a cfDNA-based methylation profiling assay, called LiquidTME, to predict responses to immune checkpoint inhibitors by interrogating cellular ecosystems tied to tumor...
FDA approval: first therapy for ultra-rare NRG1 fusion cholangiocarcinoma
Partner Therapeutics’ Bizengri has received FDA approval for advanced cholangiocarcinoma driven by NRG1 gene fusions, marking the first approved therapy for this ultra-rare genetic driver. Partner...
Clinical signal: CRISPR-modified CD33-deleted stem cell transplant in AML/MDS
A Phase I/II multicenter trial led by Washington University School of Medicine reported that a CRISPR-Cas9 CD33-deleted allogeneic hematopoietic cell transplant can reduce recurrence risk in...
Oncology efficacy readout: MYTHIC trial in platinum-resistant ovarian cancer
The MYTHIC trial presented at UT MD Anderson’s clinical development updates showed activity for lunresertib plus zedoresertib in platinum-resistant ovarian cancer, including a precision...
AI drug discovery capital infusion: Isomorphic Labs Series B
Isomorphic Labs closed a $2.1 billion Series B to scale its AI drug-discovery engine and push more programs toward clinical entry. The round, described as a major milestone for AI-first drug...
Roche expands oncology diagnostics with PathAI acquisition
Roche moved to expand oncology diagnostics into an end-to-end platform strategy by pursuing acquisitions in digital pathology and MRD monitoring. At its diagnostics day, the company described...
Gene therapy development: AAV death investigation continues at Capsida
Capsida Biotherapeutics said it still does not know what caused a child’s death in a gene therapy trial of CAP-002, which delivered genes into the brain. The company said its investigation has...
FDA leadership change and shifting regulatory environment
FDA Commissioner Marty Makary has resigned, ending a turbulent tenure that included efforts to speed drug development and repeated controversy over agency management and scientific oversight....
FDA and EU expansion of Alzheimer’s blood diagnostics
Roche secured CE marking in Europe for its Elecsys plasma pTau217 blood test, intended to help rule in and rule out amyloid pathology. The company developed the test with Eli Lilly, adding another...