Florida / New York

A Publication for the Practicing Medical Specialist, Industry Executive & Investor

BIOTECHNOLOGY

Medical Device News Magazine reports breaking biotechnology news in addition to medical device news.

Isothermal Mixes

New Hot Start Isothermal Mixes Boost Sensitivity, Specificity, and Speed of DNA Target Detection

Isothermal mixes are important in a range of isothermal amplification applications, including whole genome amplification, point-of-care assay development and testing, and strand displacement amplification for synthetic biology. However, a common issue with isothermal mixes is non-specific amplification — where primers bind to unintended DNA targets — because amplification often takes place at a fixed temperature which may favour non-specific primer interactions, contrary to PCR. Isothermal mixes can also lead to primer dimer formation, where primers associate with each other and are extended by the polymerase.

Cue Biopharma Completes Patient Enrollment in Ph1b Head & Neck Cancer Trial

“Completing the enrollment of the recommended phase 2 dose patient expansion cohort is an important milestone as the data from this trial guides further development plans and associated discussions with the Food and Drug Administration (FDA),” said Daniel Passeri, chief executive officer of Cue Biopharma.

Revvity Expands Access to Base Editing Technology with Aim to Accelerate Discovery to Cure

Michelle Fraser, head of cell and gene therapy at Revvity, underscores the importance of providing broad access to this technology: “Base editing has been extensively demonstrated in numerous studies to safely and precisely control the correction of single base changes at multiple target sites, simultaneously. This streamlined approach simplifies complex multi-gene editing, holding great promise for the development of new cell therapies targeting rare inherited genetic diseases, cancer, and in the creation of universal donor cells as the foundation of allogeneic cell therapies.”

PADCEV® (enfortumab vedotin-ejfv) and KEYTRUDA® (pembrolizumab) Significantly Improve Overall Survival and Progression-Free Survival in Patients With Previously Untreated Advanced Bladder Cancer in Pivotal Phase 3 EV-302 Trial

The EV-302 study met its dual primary endpoints of overall survival (OS) and progression-free survival (PFS), compared to chemotherapy. An Independent Data Monitoring Committee determined that OS crossed the pre-specified efficacy boundary at interim analysis. The safety results of the combination are consistent with those of enfortumab vedotin in combination with pembrolizumab previously reported in cisplatin-ineligible patients with la/mUC.