Drug Development

The Basel office will house the clinical development team and other functions to progress the company’s lead compound emapalumab.

Caladrius is selling the remaining percentage of the subsidiary in order to focus on cell therapy development.

Excipient manufacturer adds three tablet binding and disintegration products.

Human antibody for Zika virus could help in the treatment and prevention of the infection.

Effective solutions for overcoming the high molecular weight, hydrophilicity, and instability of large biomolecules have yet to be identified.

The Mutual Recognition Agreement will allow FDA and EU inspectors to recognize each other’s work and avoid the duplication of drug inspections.

Drug type, potential sales, and ownership factor in the race to get drugs to market.

Capsule filling is a complex process, and the product to be encapsulated must be well developed to ensure mass uniformity.

The UK Stem Cell Bank released validated stem-cell lines for researchers developing novel cell-based therapies for clinical trials.

Sanofi and Lonza formed a joint venture to build and operate a large-scale mammalian cell culture facility for monoclonal antibody production in Visp, Switzerland.

The agency’s CHMP recommended conditional marketing authorization for the hormone replacement therapy for the treatment of chronic hypoparathyroidism.

The authors discuss regulatory and patent issues with combination products.

Under the agreement, Abzena will manufacture magacizumab, an antibody created using the ‘Abzena inside’ Composite Human Antibody technology.

The Patent Trial and Appeal Board ruled in favor of the Broad Institute, allowing the institution to keep patents for its CRISPR-Cas9 gene-editing technology.

Improved process analytical technology and new ways of thinking seek to enhance measurement and control for next-generation pharmaceutical manufacturing.

The agency sent a warning letter to Resonance Laboratories Pvt. Ltd. after an inspection found possible contamination problems.

Soft sensors are powerful tools that can be used along with spectroscopic instruments in on-line measurement.

This three-year partnership will explore and identify new tools and methods to modify and optimize the Chinese hamster ovary (CHO) cell line performance.

The investment will be used to advance Nemaura’s R&D programs, which include liquid vaccines that have been reformulated for administration through the skin using its micropatch drug delivery technology.

Drug manufacturers need to work closely with excipient suppliers to ensure supply chain safety.

More agile techniques are improving the development of multiparticulate drug-delivery systems.

The authors look at challenges and considerations to continuously improve inspection efficiency.

FDA issued approvals for less than half the number of new drugs in 2016 compared with 2015.

The £14-million research project aims to better understand adverse drug reactions through a variety of modeling approaches.