HLF proves ‘critical’ for HSC quiescence

HSCs in the bone marrow
Preclinical research suggests hepatic leukemia factor (HLF) protects hematopoietic stem cells (HSCs) by helping them maintain quiescence. Researchers found that HLF-deficient HSCs were more sensitive than wild-type HSCs to chemotherapy and irradiation. After transplantation in mice, HLF-deficient HSCs were less able than wild-type HSCs to reconstitute hematopoiesis. These findings were published in Cell Reports. [Read Article]

EC approves product to treat hemophilia A

Vial of Adynovate, the US
version of Adynovi
Photo courtesy of Baxalta
The European Commission (EC) has granted marketing authorization for rurioctocog alfa pegol (Adynovi). Rurioctocog alfa pegol (formerly BAX 855) is a pegylated, full-length, recombinant factor VIII product built on a previously licensed recombinant factor VIII product (Advate). Rurioctocog alfa pegol is now EC-approved for on-demand and prophylactic use in patients age 12 and older with hemophilia A. With the EC’s approval, Shire is authorized to market rurioctocog alfa pegol in all member states of the European Union as well as in Iceland, Liechtenstein, and Norway. [Read Article]

FDA aims to improve access to clinical trial info

Preparing drug for a trial
Photo by Esther Dyson
The US Food and Drug Administration (FDA) says it is taking new steps to improve public access to clinical trial information. The agency is launching a pilot program to evaluate whether releasing portions of clinical study reports (CSRs) will improve public access to drug approval information. The FDA is also planning to add NCT numbers to FDA materials to make it easier to match listings on ClinicalTrials.gov to FDA communications. FDA Commissioner Scott Gottlieb, MD, noted that, when a drug is approved, the FDA releases certain information the agency used when reviewing the new drug application (NDA). [Read Article]