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Cancer immunotherapy financing and trial-readout momentum
Nouscom secured an oversubscribed $135 million Series D to accelerate NOUS-209, its off-the-shelf neoantigen-based immunotherapy program in Lynch syndrome cancer interception. The FDA granted Fast...
Inflammatory bowel disease: Gilead’s Phase 2 emvistegrast shows remission signal
Gilead Sciences reported Phase 2 results showing its oral inflammatory bowel disease candidate emvistegrast (2 00 mg daily) eliminated symptoms for patients with moderate-to-severe ulcerative...
Regulatory: new Fast Track expansion for Marengo’s invikafusp alfa
Marengo Therapeutics said the FDA expanded fast track designation for invikafusp alfa (STAR0602) across pan-tumor TMB-H solid tumors that progressed after prior therapy, including checkpoint...
Oncology and biomarkers: early response signals emerge in HCC
New findings highlighted a pair of blood signals that can diverge early and refine liver cancer therapy response assessment in hepatocellular carcinoma. The premise is that the first treatment...
CAR-T safety: predictable hematologic toxicity risk scoring
A retrospective cohort study reported that the CAR-HEMATOTOX score predicts severe neutropenia and thrombocytopenia after CAR-T cell therapy, using data from 96 patients. The analysis described...
Company legal settlement impacting pulmonary arterial hypertension product label
Liquidia shares rebounded after the company settled a long-running legal dispute with United Therapeutics, ending six lawsuits spanning patent infringement, trade secret, and antitrust claims....
Regenerative medicine: early stem cell transplants improve survival in Shwachman-Diamond syndrome
A large international study found that performing stem cell transplants soon after high-risk bone marrow features emerge sharply improves survival for youth with Shwachman-Diamond syndrome. The...
Rare infectious disease and diagnostics: rapid TB resistance prediction with audit controls
Researchers reported a dual-pathway deep learning system that predicts tuberculosis drug resistance with over 95% accuracy while auditing sequencing quality and recovering both canonical and novel...
Clinical trial design and CMC planning: guidance on when to engage CDMOs
A new industry analysis focused on CDMO engagement timing argued that companies should involve contract development and manufacturing organizations early in development while keeping key CMC...
Health system and funding ecosystem: Saudi Arabia ramps biotech buildout
Saudi Arabia’s national biotechnology strategy has moved from a policy target toward operational partnerships, according to reporting on agreements announced at the Riyadh Global Medical...
FDA fast-track immuno-oncology expand
Marengo Therapeutics’ bispecific immuno-oncology agent invikafusp alfa (STAR0602) won an expanded FDA fast track designation across TMB-H solid tumors after prior therapy, including patients...
Liquidia-Udly United settlement reshapes PH-ILD label
Liquidia’s patent settlement with United Therapeutics resolved six lawsuits tied to treprostinil inhalation, with Liquidia agreeing to pay $380.7 million and to remove pulmonary hypertension...
Company financing for rare endocrine therapy
OMass secured $310 million to advance a drug program for congenital adrenal hyperplasia, targeting an option intended to compete in a market dominated by Neurocrine’s current FDA-approved therapy....
AI-and-CT biomarkers move toward noninvasive oncology decisions
A sequence of imaging AI studies reported new approaches to predict tumor features without invasive sampling, including a model that reads routine CT urography to predict bladder cancer HER2...
Single-cell insights into AML relapse after transplant
Single-cell sequencing work mapped distinct T-cell exhaustion programs that emerge in acute myeloid leukemia before and after transplant, linking relapse biology to different transcriptional...
CAR-T toxicities: gut persistence drives severe intestinal inflammation
A Mount Sinai study reported that BCMA-directed CAR-T cells can linger in the gut and correlate with severe intestinal inflammation in a subset of patients. The finding ties therapy persistence in...
Clinical trial: sparing chemotherapy in early breast cancer
The phase 3 RxFINE-Low trial will test whether some early-stage breast cancer patients can safely omit chemotherapy when they have low genomic risk but high anatomic risk. Enrolled patients will...
Microfluidic protein engineering scale-up
Caravel Bio advanced a microfluidic platform for protein engineering that couples cell-free synthesis in microdroplets with a bacterial spore-based display concept. The approach targets industrial...
Clinical delivery systems: Solusome improves oral bioavailability
Researchers developed ebastine-loaded Solusome nanovesicle oral lyophilisates designed to disintegrate quickly in the mouth and boost systemic exposure. In rats, the formulation increased ebastine...
Diagnostics and epidemiology: low-cost CRISPR test for Babesia
Thailand-based researchers reported that a cheap Tris–EDTA buffer DNA extraction method can match commercial extraction kits when paired with RPA and CRISPR–Cas12a for rapid detection of Babesia...