Pharmaceutical Technology Editors

CMC Biologics will manufacture monoclonal antibodies (mAbs) and provide process development services for the PATH Malaria Vaccine Initiative.

GlaxoSmithKline has temporarily shut down its manufacturing plant in Zebulon, North Carolina after Legionnella bacteria was found in a stand-alone cooling tower during routine inspection.

The reconfigured Sartobind membrane adsorber capsules from Sartorius Stedim Biotech is said to have higher binding capacities, reduced void volumes, as well as consume less buffer, enabling lower operational costs.

Catalent selects advisory board members to complement Redwood Bioscience Scientific Advisory Board.

The agency issues guidance for companies considering registering with FDA as an outsourcing facility.

Wourld Courier's Climate Optimisation Research & Engineering (CORE) Lab near Cologne, Germany, will enhance package evaluation and validation.

Deal includes rights to Inovio’s INO-3112 HPV cancer vaccine and preclinical collaboration to develop additional cancer vaccine candidates.

This new range includes antibodies conjugated to various enzymes, fluorescent dyes, and colloidal gold, for improved flexibility in experimental design.

Unlike pharmaceutical manufacturing in the West, China’s growth is not merely a result of the increasing sales of finished formulations in highly regulated markets.

The company’s Scotland-based facility has successfully completed a scheduled inspection by the UK’s MHRA; there were no critical or major observations noted.

Flexion will have a dedicated manufacturing suite at Patheon's Swindon, England facility for Flexion's osteoarthritis steroid drug product.

The new, still unnamed biosciences arm of Emergent BioSolutions will be a separate public company with a focus on novel therapeutics in immuno-oncology.

US generics manufacturer Amneal acquires a former J&J plant in Ireland.

The agreement gives Merck a non-exclusive license to use Codexis’ proprietary CodeEvolver protein engineering platform technology to develop novel enzymes for use in the manufacture of Merck’s pharmaceutical products.

The acquisition strengthens Shire’s ophthalmics portfolio.

World on the verge of an effective Ebola Vaccine according to WHO.

Shire takes its offer for an all-stock transaction to combine with Baxalta to shareholders after Baxalta declines to discuss the proposal.

Aprecia Pharmaceutical’s SPRITAM levetiracetam gains FDA approval for the treatment of epilepsy.

FDA issues draft guidance on dissolution testing for immediate-release solid oral dosage forms.

FDA issues guidance regarding fees for drug compounding outsourcing facilities.

The investment doubles the company’s capacity to meet increasing demand for its biologics contract testing and biosimilar characterization services.

Drug development is South Korea is being driven by the government’s R&D strategy under its Pharma 2020 Vision.

The new service offering includes feasibility studies, process and analytical development, and scale-up from milligram to gram quantities required for pilot and subsequent commercial scale.

Teva Parenteral Medicines initiates voluntary nationwide recall of select lots of Adrucil due to particulate matter.

Baxter has recalled of one lot of IV solution due to the potential for leaking containers, particulate matter, and missing port.

“Rough notes” documentation and data management failures lead to warning letter for Mahendra Chemicals.

Investment in Powdersize adds particle-size control solutions to Xcelience’s capabilities.

Lupin acquires businesses in Germany, the US, Russia, Brazil, and South Africa.

Avista grows its contract services business, and Scynexis focuses on antifungal development.

ARGX-110-based combination therapies have demonstrated potential in treatment-resistant cancers.