Subcutaneous zilucoplan: evaluation of reproductive toxicology.

To further understand the safety profile of zilucoplan, reproductive toxicology studies in non-human primates (NHPs) were performed, including a male fertility study and a combined embryo-foetal development (EFD) and enhanced pre- and postnatal development (ePPND) study. Human transplacental transfer of zilucoplan was examined in an ex vivo human placental perfusion model of foetal exposure during pregnancy. By comparison with the positive control, a low transfer rate of 0.

Evaluation of the effect of rozanolixizumab on pregnancy outcomes and pre- and postnatal development in cynomolgus monkeys.

Rozanolixizumab, a humanised immunoglobulin (Ig) G4 monoclonal antibody that selectively inhibits binding of IgG to the neonatal Fc receptor (FcRn), was evaluated in an embryo-foetal enhanced pre- and postnatal development (ePPND) study. Pregnant female cynomolgus monkeys (19 per group) received subcutaneous rozanolixizumab 50 mg/kg or 150 mg/kg or vehicle every 3 days from gestation day 20 until delivery. The proportion of pregnancy losses was 15.

Genetic diversity for drought tolerance in the native forage grass and possible morpho-physiological mechanisms involved.

Introduction: The use of drought tolerant genotypes is one of the main strategies proposed for coping with the negative effects of global warming in dry lands. is a native forage grass occupying extensive arid and semi-arid regions in the American continent, and used for range grazing and revegetation of degraded lands.

Methods: To identify drought-tolerant genotypes and possible underlying physiological mechanisms, this study investigated drought tolerance in 21 genetically diverse genotypes under natural field conditions.

High Temperature Alters Anthocyanin Concentration and Composition in Grape Berries of Malbec, Merlot, and Pinot Noir in a Cultivar-Dependent Manner.

Climate is determinant for grapevine geographical distribution, berry attributes, and wine quality. Due to climate change, a 2−4 °C increase in mean diurnal temperature is predicted by the end of the century for the most important Argentine viticulture region. We hypothesize that such temperature increase will affect color intensity and other quality attributes of red grapes and wines.

Scientific and Regulatory Policy Committee Points to Consider: Nonclinical Research and Development of In Vivo Gene Therapy Products, Emphasizing Adeno-Associated Virus Vectors.

Sequencing of the human genome and numerous advances in molecular techniques have launched the era of genetic medicine. Increasingly precise technologies for genetic modification, manufacturing, and administration of pharmaceutical-grade biologics have proved the viability of in vivo gene therapy (GTx) as a therapeutic modality as shown in several thousand clinical trials and recent approval of several GTx products for treating rare diseases and cancers. In recognition of the rapidly advancing knowledge in this field, the regulatory landscape has evolved considerably to maintain appropriate monitoring of safety concerns associated with this modality.