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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...
Regulatory real-time trials and FDA modernization
The FDA launched a pilot framework for real-time clinical trials, allowing sponsors to report endpoint and safety signals as data are generated rather than waiting for study completion. The agency...
Big pharma shifts: U.S. job cuts tied to commercial strategy
Novartis announced an additional round of layoffs at its U.S. headquarters, adding about 60 more roles linked to the East Hanover site later this year. The company said the move follows earlier...
Strategic retrenchment after FDA design rejection in gene therapy
Passage Bio launched a strategic review and disclosed plans to cut roughly 75% of its workforce after the FDA signaled it would not accept a single-arm registrational trial design for PBFT02 in...
Corporate dealmaking in autoimmune T-cell engagers
UCB agreed to acquire Candid Therapeutics in a $2 billion upfront deal, aiming to accelerate its autoimmune pipeline with two clinical-stage T-cell engagers. Candid will terminate its planned...
Oncology readouts and regulatory paths in colorectal cancer
Oncolytics Biotech updated efficacy from the Phase 1 REO 022 trial, reporting a 19.5-month median duration of response and a 33% overall response rate for pelareorep combined with bevacizumab and...
Cystic fibrosis mRNA program discontinued by Vertex
Vertex Pharmaceuticals dropped development of an mRNA-based cystic fibrosis therapy, citing tolerability and delivery challenges after pausing related programs earlier in the field. The company...
Diagnostics growth and guidance lift for Biodesix
Biodesix reported a 42% year-over-year jump in first-quarter 2026 revenue and raised full-year guidance after the company’s diagnostic testing business accelerated. Total Q1 revenue reached $25.6...
New drug pipeline economics: Veristat buys Certara regulatory unit
Veristat agreed to acquire Certara’s regulatory and medical writing business for up to $135 million, expanding the contract services provider’s regulatory submission and documentation capacity....
Trade regulation and pricing pressure in biopharma and med-tech
The U.S. Trade Representative named Vietnam as a Priority Foreign Country in its latest Special 301 Report, calling out pricing and intellectual property issues affecting biopharma and med-tech....
Autonomous funding: Latus Bio series A for AAV capsid platform
Latus Bio closed a $97 million Series A to advance a therapeutics pipeline built around novel AAV capsid variants, funding operations through milestones tied to early clinical data. The company...
Regulatory innovation at FDA
The U.S. Food and Drug Administration is piloting “real-time clinical trials” (RTCTs) that stream endpoint and signal information as studies run, aiming to shorten the lag between first data and...
Big pharma M&A in immune-oncology and autoimmune T-cell engagement
UCB is moving aggressively to expand its immune-engaging portfolio, agreeing to acquire privately held Candid Therapeutics for $2 billion upfront plus up to $200 million in milestones. The deal...