The drug was the first PCSK9 inhibitor approved in Europe and the second approved in the US.

Shimadzu Scientific Instruments reports its EDX-7000/8000 spectrometers are compliant with electronic signature regulations.

Mayne Pharma plans to double oral-dose manufacturing space and expand contract services.

GSK announces plan to divest its rights in ofatumumab for auto-immune indications for up to $1 billion.

The TRUST project will focus on the process development of Col-Treg, which is TxCell’s autologous collagen type II specific Treg immunotherapy product for the treatment of autoimmune uveitis.

In a new draft guidance, FDA proposes the use of a nonproprietary name plus a four-letter suffix to identify all biologic products, both new and old.

Recipharm will be responsible for the supply of the remaining clinical-trial material and ongoing future commercial supply of RHB-105, the lead drug candidate developed by RedHill for the treatment of Helicobacter pylori bacterial infection.

Set to take place in Hannover, Germany from October 6–8, 2015, BIOTECHNICA is one the major events in Europe that brings together players in the biotechnology, life sciences, and lab technology sectors.

WuXi's Laboratory Testing Division will be the exclusive supplier of laboratory testing services for Hong Kong-based Lee's Pharm.

Pfizer agrees to divest four sterile injectable assets to clear the way to complete acquisition of Hospira.

Cytovance Biologics anticipates continued expansion plans following acquisition by Hepalink USA

Shire requests a technical transfer from Sanquin to widen its manufacturer base for the production of Cinryze.

Experts from Dow Pharma & Food Solutions discuss the versatility of solid dispersions in solubility enhancement and the importance of pairing the active pharmaceutical ingredient to the optimal polymer.

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.

The agency issued guidance regarding common issues involved with the development of treatments for rare diseases.

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.