News

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.

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FDA issues draft guidance on dissolution testing for immediate-release solid oral dosage forms.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

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

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

Competitive pressures are driving more companies to repurpose APIs that had originally been developed for other indications. The industry has only "scratched the surface" of what might be possible, says consultant Hermann Mucke

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.