Tag: clinical trials

April 9, 2021

Bora Pharmaceutical Laboratories, a division of Bora Pharmaceuticals, has added roller compaction technology to its solid dose capability offerings at its Zhunan, Taiwan contract manufacturing and packaging facility. The Zhunan facility manufacturers complex oral solid dose (OSD) formulations with expertise […]

April 7, 2021

Oxidative stress is caused by an imbalance between production and accumulation of oxygen reactive species (ROS) in cells and cells . Manganese superoxide dismutase (MnSOD) is an antioxidant enzyme that protects the mitochondria from oxidative damage by using a mechanism […]

April 6, 2021

Shanghai Stock Exchange listed biotech company HitGen Inc. (“HitGen”) announced important research progress in a collaboration with BioAge Labs, Inc. (“BioAge”), a private biotechnology company developing targeted small molecules for the treatment of diseases of aging. The companies have conducted […]

April 1, 2021

In January 2020, the US Food and Drug Administration (FDA) published a series of seven guidances regarding cell and gene therapy. These have not come too soon, given some much-publicised regulatory rejections. For example, the FDA turning down the Biologics […]

March 31, 2021

One of the most important decisions in the history of the Food and Drug Administration is quickly approaching. By early June, the agency should have a verdict on whether to approve aducanumab, a potentially first-of-its-kind treatment for Alzheimer’s disease that […]

March 30, 2021

Abecma (idecabtagene vicleucel; ide-cel) has been cleared for use in adult patients with relapsed or refractory multiple myeloma, after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 monoclonal antibody. In the […]

March 30, 2021

According to Transparency Market Research’s latest report on the global clinical trials management system (CTMS)market for the historical period 2017–2018 and forecast period 2019–2027, rising demand for new therapies and increasing research and developmental activities to drive the global clinical […]

March 24, 2021

The cell and gene therapy field hit major milestones over the last few years. In the summer of 2017, the Food and Drug Administration approved a first-of-its-kind cellular medicine from Novartis for a hard-to-treat form of leukemia. Less than two […]

March 24, 2021

Synthetic data is based on real-world data sets, used to accurately predict the ‘synthetic patient profile’ and deploy a virtual cohort in a clinical trial. The report is the first in a series exploring the use of synthetic data in […]

March 19, 2021

Thrombosis Canada has reviewed recent reports from the United Kingdom and Europe relating to the SARS-CoV-2 (COVID-19) vaccine made by AstraZeneca and the development of a very rare type of thrombosis (blood clots) that is associated with thrombocytopenia (low blood […]

March 19, 2021

The small intestine is responsible for absorbing our dietary nutrients, but it also plays a role in warding off toxic chemicals and life-threatening bacteria. Yale researchers now report on the critical role that the gut’s immune system plays in these […]

March 18, 2021

Messenger RNA technology, which uses synthetic, genetic material to teach the body to make helpful proteins, has come of age over the past year. When the coronavirus pandemic took hold in 2020, the technology was uniquely suited to meet the […]