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FDA approval ushers a new allogeneic Treg cell-therapy category
The FDA cleared Orca Bio’s Tregzi (formerly Orca-T), marking the first approval for a cell therapy built on regulatory T cells (Tregs) rather than the more common conventional T-cell approach. The...
Ipsen expands rare-disease portfolio by buying Memo’s BK virus antibody asset
Ipsen announced it will acquire Memo Therapeutics to add potravitug, a phase 2-ready monoclonal antibody targeting BK polyomavirus associated nephropathy in kidney transplant patients. The deal...
QuantumCell licenses AlzeCure Alzheimer’s candidate in a deal valuing milestones at $2.2B
QuantumCell struck a licensing deal with AlzeCure Pharma to obtain global rights to ACD856, a small-molecule Trk positive allosteric modulator built to modulate NGF/TrkA and BDNF/TrkB signaling....
FDA and clinical transparency collide: Vistagen’s Phase 3 social anxiety miss sends stock into freefall
Vistagen’s intranasal program fasedienol missed in a Phase 3 trial (PALISADE-4) for acute treatment of social anxiety disorder, failing to outperform placebo on the primary endpoint tied to...
Data integrity scrutiny: Tavneos pivotal trial retraction complicates Amgen’s regulatory defense
The New England Journal of Medicine retracted the 2021 pivotal Phase 3 report for Amgen’s Tavneos (avacopan) after FDA investigations found primary endpoint assessments for nine patients were...
Merck ends a Phase 2 Alzheimer’s trial in another blow to Neuphoria’s program
Merck terminated a Phase 2 Alzheimer’s study of oral drug candidate MK-1167 after an interim analysis showed the asset underperformed. The decision ends another mid-stage attempt in Merck’s...
Clinical evidence for new biomarkers: SkylineDx wins FDA Breakthrough Device designation for melanoma risk profiling
SkylineDx received FDA Breakthrough Device designation for Merlin CP-GEP, a clinicopathologic gene expression profiling assay intended to support risk assessment in early-stage cutaneous melanoma....
FDA manufacturing policy signal: PreCheck pilot clears its first flight for onshoring-ready plant assessments
FDA launched the first set of regulatory “PreCheck Rx” manufacturing pilot steps, clearing the initial flight involving seven biopharma companies for pre-assessment of facilities before product...
AI investment in specialty pharmacy: Evernorth backs a $100M AI-driven program
Evernorth announced a $100 million investment through 2028 in Pharmacy Forward, an AI-powered specialty pharmacy program aimed at improving specialty pharmacy operations and patient care. The...
Production capacity and supply-chain resilience: Cytiva doubles a key liquid media manufacturing site
Cytiva completed expansion of its Logan, Utah liquid media production capacity, effectively doubling output to support supply continuity for customers dependent on the company’s cell culture...
Cell therapy approval for GVHD-risk reduction
The FDA has approved Orca Bio’s Tregzi, the first cell therapy built on regulatory T cells, to reduce the risk of chronic graft-versus-host disease in patients undergoing matched-donor allogeneic...
Strategic licensing deal advances Alzheimer’s candidate
QuantumCell has signed a licensing deal with AlzeCure Pharma to acquire global rights to Alzheimer’s drug candidate ACD856, following AlzeCure’s prior partnerships including Eli Lilly’s...
Immunology deal expands rare disease infectious burden strategy
Ipsen announced plans to acquire Memo Therapeutics for about €700 million (US$797 million), adding potravitug, a phase 2-ready monoclonal antibody targeting BK virus-associated infections and...
HIF-2α inhibitor: link to treatment response in ccRCC
Arcus Biosciences reported Nature-published data connecting circulating erythropoietin dynamics to treatment response in patients with metastatic clear cell renal cell carcinoma receiving...
KRAS-directed immuno-oncology and T-cell targeting assets
UCL and the University of Oxford have engineered a CAR T-cell therapy concept aimed at eradicating malignant stem cells driving myeloproliferative neoplasms, using CAR targeting directed to a...
Prevention biomarkers and FDA regulation for gene editing CMC
A pair of developments spotlight both regulatory and manufacturing progress for genome engineering. First, Bioprocessing Summit speaker Kok-Seong Lim discussed how personalized CRISPR gene-editing...
Venture financing supports immune and oncology platforms
Beeline Medicines expanded its Series A fundraising by adding $126.3 million, bringing total disclosed capital to $426.3 million as it advances afimetoran for lupus and progresses other immunology...
FDA quality and data integrity warning to Genzyme site
FDA issued a warning letter to Genzyme’s Ireland manufacturing site, raising quality and data-integrity concerns linked to manufacturing controls. The letter, tied to the site now owned by Sanofi,...
Screening coverage for colorectal tests
UnitedHealthcare has agreed to cover Guardant Health’s Shield colorectal cancer screening test as a first-line assay, driving a sharp market reaction for Guardant stock. The insurer’s decision...
Alzheimer’s trial termination after interim underperformance
Merck has terminated a Phase 2 Alzheimer’s trial testing oral candidate MK-1167, citing underwhelming results in an interim analysis. The decision marks another setback for Neuphoria Therapeutics,...