Tag: clinical trials

Biotech, Industry

Bora Pharmaceuticals Adds Roller Compaction Capabilities

April 9, 2021

Via: Contract Pharma

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 […]

Clinical Trials, News, Research and Development

Researchers Expose Hidden Atomic Portrait of Antioxidant Enzyme

April 7, 2021

Via: Genetic Engineering and Biotechnology News

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 […]

Biotech, Cell and Gene Therapy, Industry

HitGen and BioAge Announce Research Progress in DNA-Encoded Library Based Drug Discovery Research Collaboration

April 6, 2021

Via: BioSpace

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 […]

Cell and Gene Therapy, FDA, Industry, Regulations

How to gear up for more stringent gene and cell therapy regulations

April 1, 2021

Via: EPM Magazine

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 […]

FDA, Regulations

FDA advisers reassert case against approval of Biogen’s Alzheimer’s drug

March 31, 2021

Via: Biopharma Dive

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 […]

Clinical Trials, FDA, Regulations, Research and Development

FDA green light for BMS, bluebird bio’s CAR-T therapy Abecma in multiple myeloma

March 30, 2021

Via: Pharma Times

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 […]

Clinical Trials, News, Research and Development

Clinical Trial Management System Market: Software is anticipated to be Most Lucrative Segment

March 30, 2021

Via: BioSpace

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 […]

Cell and Gene Therapy, Industry

Drugmakers flock to Vineti’s fix for a cell, gene therapy problem

March 24, 2021

Via: Biopharma Dive

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 […]

Clinical Trials, Research and Development

Report urges pharma companies to utilise synthetic data in clinical trials

March 24, 2021

Via: Pharma Times

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 […]

Industry, News, Vaccines

Updated Statement on Covid-19 Vaccines and Thrombosis From Thrombosis Canada

March 19, 2021

Via: BioSpace

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 […]


Gut Immune System Cells Act to Regulate Nutrient Uptake in Small Intestine

March 19, 2021

Via: Genetic Engineering and Biotechnology News

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 […]

Biotech, Clinical Trials, Industry, Research and Development

A first-of-its-kind mRNA drug falls short in cystic fibrosis

March 18, 2021

Via: Biopharma Dive

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 […]