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.

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.

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.

European Union regulators said Pfizer must divest its infliximab biosimilar candidate and some sterile injectables for the merger with Hospira to be completely approved.

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.

Paperless operations improve efficiency and increase assurance of product quality.

The trend towards personalized medicines in Europe requires a more integrated framework that regulates the approval of devices and diagnostics.