Allergan issued a voluntary nationwide recall in the US of specific lots of ophthalmic ointment after customers complained of black particles, which came from the cap.

Elizabeth Scheu & Kniss will supply replacement parts for Bosch capsule filling machines.

Biopharmaceutical company BeiGene plans to build facility in Suzhou to expand its clinical capability and prepare for commercial manufacturing.

Paperless operations improve efficiency and increase assurance of product quality.

Mylan received a warning letter citing violations at its Agila Specialty Formulation Facility, Sterile Products Division, and Onco Therapies Limited sites in India.

Citing failure to meet child-resistant closure requirement, Merck has advised that all bottles should be examined for cracks and that affected bottles should be kept out of children’s reach.

GSK reports no employee injuries at the facility and is assessing damage.

Novartis will develop AVEO’s AV-380, an investigational humanized antibody targeting growth differentiation factor 15.

With this acquisition, Source BioScience is now able to offer integrated solutions to customers, with environmentally controlled storage in combination with the required up- or downstream analytical testing services.

FDA’s Center for Drug Evaluation and Research provides guidance on development plans for botanical drugs.

The company adds a few new arguments-as well as new stakeholder support-to its Citizen Petition on biosimilar naming.

*This article is an opinion piece and does not necessarily represent the views of BioPharm International.

The company is in discussions with Europe’s Adaptive Pathways Group on clinical trials that would evaluate its PLX cells for the treatment of specific diseases.

Licenses could potentially bring antibody R&D to areas beyond oncology, such as diabetes treatments.

The expansion will enable relocation of its North American headquarters from Grayslake, Illinois.

Companies in the US will now have the opportunity to tap into Hermes Pharma’s technical expertise in effervescent and chewable tablets, instant drinks, lozenges, and orally disintegrating granules (ODGs).

WuXi PharmaTech and TruTag Technologies successfully applied and detected TruTag's edible microtags on solid-dosage drug products and found no effect on dissolution.

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.

Following a divestiture of certain assets in Europe, the acquisition of Sigma-Aldrich by Merck KGaA will be complete.

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

The Biosimilars Forum, along with numerous House members, advocated for the use of unique J-codes for biosimilars in a recent letter to CMS.

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.