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Regulators move toward real-time signal sharing in early trials
The FDA launched a pilot program for real-time clinical trials (RTCTs) intended to accelerate early-phase development by letting sponsors report safety signals and endpoint data as trials...
FDA access restored for mifepristone via telemedicine and mail
The U.S. Supreme Court temporarily reinstated online access to the abortion pill mifepristone by mail, pausing a federal appeals court ruling that had blocked prescribing by phone and through the...
Big pharma reshuffles US commercial workforce
Novartis added another wave of US job cuts tied to its East Hanover headquarters, according to a WARN filing. The company said it will lay off about 60 roles later this year, separate from a prior...
New immuno-oncology platform funding: gamma delta T-cell engager push
Cytospire raised £61 million (about $83 million) in a Series A to advance CYT X300, its gamma delta T-cell engager program for solid tumors. The London-based biotech said it plans early testing in...
UCB expands autoimmune pipeline with $2B bid for Candid
UCB agreed to acquire Candid Therapeutics in a $2 billion upfront deal, with up to $200 million in milestones, to add two clinical-stage T-cell engager assets for autoimmune diseases. The...
Oncolytics updates durability in REO 022 and weighs accelerated approval strategy
Oncolytics Biotech reported updated Phase 1/REO 022 efficacy data for pelareorep (Reolysin) in combination with bevacizumab and FOLFIRI in second-line RAS-mutant microsatellite-stable metastatic...
Vertex drops mRNA cystic fibrosis program over tolerability and delivery challenges
Vertex discontinued development of an mRNA-based cystic fibrosis therapy after encountering tolerability issues tied to how the genetic medicine was delivered. The company said challenges in...
Company pivots after FDA blocks gene therapy path for frontotemporal dementia program
Passage Bio announced a strategic review and a plan to cut 75% of its workforce after an FDA Type C meeting challenged the design for its lead gene therapy PBFT02 in frontotemporal dementia with...
Diagnostic approvals: Applied BioCode expands automated respiratory pathogen testing clearance
Applied BioCode received expanded FDA 510(k) clearance for its BioCode Respiratory Pathogen Panel (RPP) workflow to incorporate automated extraction using Thermo Fisher Scientific’s KingFisher...
FDA and trial design discipline hits IPO timing—Odyssey targets Nasdaq raise for UC pipeline
Odyssey Therapeutics refiled for a Nasdaq IPO aiming to raise up to about $236.6 million, with proceeds earmarked to advance its ulcerative colitis pipeline. The filing indicates Odyssey plans to...
Regulatory acceleration and FDA real-time oversight
The FDA moved toward faster early-phase drug development by piloting real-time clinical trials (RTCTs), in which sponsors report signals and endpoints as data are generated. The agency says it...
T-cell engager M&A and big pharma expansion in autoimmune
UCB pressed deeper into T-cell engager development by agreeing to acquire Candid Therapeutics for up to $2.2 billion, combining two clinical-stage autoimmune bispecific programs with Candid’s lead...
Vertex exits inhaled and mRNA cystic fibrosis efforts over tolerability
Vertex Pharmaceuticals dropped an mRNA-based cystic fibrosis therapy, citing delivery and tolerability challenges that the company says resemble issues seen in other parts of the gene-medicine...
IBD combo trial misses—J&J plans to continue despite endpoint failure
Johnson & Johnson’s DUET program evaluating JNJ-4804, a combination of Tremfya and Simponi for inflammatory bowel disease, missed its primary endpoint for clinical remission. J&J reported that the...
Gene therapy funding and first-in-human push at Latus Bio
Latus Bio secured a new $97 million Series A to advance an AAV capsid-variant platform, funding initial clinical progress for its Huntington’s disease and late-infantile CLN2 programs. The...
Virology and diagnostics infrastructure: Applied BioCode expands automated respiratory testing clearance
Applied BioCode won expanded FDA 510(k) clearance for its BioCode Respiratory Pathogen Panel (RPP), adding automated extraction using Thermo Fisher Scientific’s KingFisher Flex platform. The...
Regulatory and commercial momentum in oncology: pelareorep durability and possible accelerated approval pathway
Oncolytics Biotech reported updated Phase 1 data for pelareorep combined with bevacizumab and FOLFIRI in second-line RAS-mutant microsatellite-stable colorectal cancer, highlighting a median...
Windward Bio funding to push long-acting asthma target into Phase 3
Windward Bio raised a $165 million crossover financing to move its long-acting anti-TSLP antibody into Phase 3 for asthma. The Swiss biotech is positioning its drug for twice-yearly dosing as a...
Clinical setbacks and restructuring at Passage Bio after FDA feedback
Passage Bio disclosed it will cut roughly 75% of staff after the FDA required a different registrational trial design for PBFT02 in frontotemporal dementia with granulin mutations (FTD-GRN). The...
Immunogenetics in aplastic anemia: stem-cell escape via independent mutations
Researchers at St. Jude Children’s Research Hospital reported that in aplastic anemia, multiple independent blood stem cell clones can acquire gene mutations that allow immune escape within the...