AI at the Crossroads: FDA and Industry Chart a Risk-Based Path for Drug Development
At a landmark FDA workshop on artificial intelligence (AI) in drug development, regulators and industry leaders outlined a vision...
ProofPilot and Lokavant Aquisition: Aligning Trial Ops with Predictive Analytics
In this interview, we sit down with Chris Venezia, CEO, and Joseph Kim, Chief Strategy Officer at ProofPilot, to...
Embedding Patient Advocacy in R&D: The Next Frontier in Pharma Collaboration
At a recent industry panel at SCOPE Europe, experts from advocacy organizations and pharmaceutical companies explored a striking imbalance:...
BlossomHill’s Promising Early Trial Data for NSCLC Drug
In the dose escalation of the first-in-human SOLARA study, BH-30643 was administered to 39 previously treated EGFR-mutant NSCLC patients...
Flare Therapeutics Reveals FX-909 Phase 1 Study Results
In Part A of a Phase 1 study in advanced urothelial carcinoma (UC), FX-909 monotherapy produced five objective responses...
Successful Phase 1 Data for REM-422 in Cancer Patients
REM-422, an oral small-molecule mRNA degrader targeting MYB, produced a 43% overall response rate by RECIST in the efficacy...
Halda’s New Prostate Cancer Drug Shows Encouraging Activity
In a first-in-human Phase 1/2 study of HLD-0915 in metastatic castration-resistant prostate cancer, 31% of all 31 treated patients...
Evolving Urticaria Treatment Highlights Unmet Patient Needs
Two-thirds of U.S. physicians report high unmet need in chronic spontaneous urticaria (CSU) despite two recent FDA approvals, according...
New TDP-43 PET Tracer: A Breakthrough for Precision Medicine
Preclinical data published in Nature Communications characterize AC Immune’s fluorine-18–labeled TDP-43 PET tracer, ACI-19626, showing high affinity for pathological...
Sobi’s Commitment to Rare Disease Care at ACR Convergence
In post-hoc analyses of the Phase 3 DISSOLVE trials in uncontrolled gout, nanoencapsulated sirolimus plus pegadricase (NASP) drove rapid...