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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...
Phase 3 efficacy signals in oncology pipelines
Celcuity reported phase 3 results for gedatolisib, a pan-PI3K/mTOR inhibitor, in HER-positive, HER2-negative, PIK3CA wild-type advanced breast cancer, saying the trial cleared its primary...
Oncolytics advances accelerated-approval path for oncolytic virus regimen
Oncolytics Biotech updated efficacy from the phase 1 REO 022 study of pelareorep (Reolysin) combined with bevacizumab and FOLFIRI in second-line KRAS-mutant, microsatellite-stable metastatic...
Windward Bio scales long-acting respiratory program with late-stage push
Windward Bio raised $165 million in a financing designed to carry its long-acting anti-TSLP antibody into phase 3 testing for asthma. The company’s approach targets twice-yearly dosing as a...
Gene therapy startup funding and trial initiation
Latus Bio closed a $97 million series A to advance an AAV capsid-variant platform with two lead programs: LTS-201 for Huntington’s disease and LTS-101 for late-infantile neuronal ceroid...
Applied diagnostics automation expands FDA-cleared testing workflows
Applied BioCode received expanded FDA 510(k) clearance for its multiplex respiratory pathogen panel, adding an automated extraction workflow using Thermo Fisher Scientific’s KingFisher Flex...
Regulatory and market development in contract services for life sciences
Veristat agreed to buy Certara’s regulatory and medical writing business for up to $135 million, aiming to broaden services for pharma and biotech clients. Veristat said the deal will add more...
Biotech investment in new therapeutic modalities for rare disease
In a move aimed at accelerating clinical translation, Windward Bio and other investors continue to back modality-led startups—while Latus Bio’s series A supports gene therapy candidates selected...
Novel biomarkers for oncology risk stratification
Caris Life Sciences said its ultra-deep whole-genome sequencing assay, ChromoSeq, has secured MolDx coverage for myeloid malignancies. The company positioned the test for sensitive detection of...