After the failure of several NASH drugs from Novartis, Boehringer Ingelheim, Genfit, Gilead, Albireo and NGM, the field of nonalcoholic steatohepatitis (NASH) finally ushered in positive progress. Intercept announced the latest data from the pivotal Phase 3 REGENERATE study of its representative dru Read More

By Stephanie Gaulding, managing director, Pharmatech Associates—a USP companyBuilding strong relationships with chosen outsourcing partners, namely contract development and manufacturing organizations (CDMOs) and contract research organizations (CROs), relies on a solid outsourcing framework. Part o Read More

by Thomas Peither, GMP-Verlag Peither AGA CAPA system should be understood as an important element of the pharmaceutical quality system and implemented uniformly throughout the company or group. In principle, it can be implemented in two different ways: as an autonomous or as an integrated system. I Read More

By Antoine Awad, chief operating officer, Synlogic, Inc.The rise of high-throughput molecular biology and DNA sequencing, in parallel with the increased sophistication of computational models, has enabled the field of synthetic biology, where precision genetic engineering is used to “program” bacter Read More

By: Luis Borges, PhD, Chief Scientific Officer and Hy Levitsky, MD, Head of R&D, Century TherapeuticsAutologous, genetically engineered T cells expressing chimeric antigen receptors (CAR-T) have dramatically reshaped treatment of multiple hematologic malignancies. Despite their benefit, these indivi Read More

Heart failure with preserved ejection fraction (HFpEF) is a difficult disease with high morbidity and mortality rates and lacks an effective treatment. Here, we report the therapeutic effect of dapagliflozin, a sodium-glucose cotransporter 2 inhibitor (SGLT2i), on hypertension + hyperlipidemia-induced HFpEF in a pig model. HFpEF pigs were established by infusing a combination of deoxycorticosterone acetate (DOCA) and angiotensin II (Ang II), and Western diet (WD) feeding for 18 weeks. In the 9th week, half of the HFpEF pigs were randomly assigned to receive additional dapagliflozin treatment (10 mg/day) by oral gavage daily for the next 9 weeks. Blood pressure, lipid levels, echocardiography and cardiac hemodynamics for cardiac structural and functional changes, as well as epinephrine and norepinephrine concentrations in the plasma and tissues were measured. After sacrifice, cardiac fibrosis, the distribution of tyrosine hydroxylase (TH), inflammatory factors (IL-6 and TNF-α) and NO-cG Read More

The C-aryl glucoside 6 (dapagliflozin) was identified as a potent and selective hSGLT2 inhibitor which reduced blood glucose levels in a dose-dependent manner by as much as 55% in hyperglycemic streptozotocin (STZ) rats. These findings, combined with a favorable ADME profile, have prompted clinical evaluation of dapagliflozin for the treatment of type 2 diabetes. Read More