The agency releases guidance on the nonclinical evaluation of endocrine-related drug toxicity.

The agency releases guidance on good review practice for formal dispute resolution in regards to appeals.

The agency has set up a workshop on how to demonstrate the benefits of orphan drugs over existing treatments.

The partners will collaborate on a project to capture and integrate clinical trial data metrics on investigational cancer medications.

Pfizer closes the acquisition of Hospira, adding sterile injectables business to portfolio.

After many legal proceedings surrounding the first FDA-approved biosimilar, Zarxio officially launched commercially on Sept. 3, 2015.

Operator attention to detail and adherence to procedures are crucial for proper cleaning.

Siegfried Schmitt, principal consultant, PAREXEL, discusses how to assure compliance for automated systems.

Worldwide, meetings take place for several reasons, such as to share new findings, learn about novel technologies, discuss international issues, exchange know-hows, and network, to name a few. While each of these reasons has its significant importance, what really matters in scientific inquiry is progress.

Ensuring data integrity involves effort on an individual and global basis.

The collaborative effort will be focused on fully humanized antibodies.

The platform, developed by Vectron Biosolutions, will be used for BI’s in-house pipeline and for its outsourcing clients.

Under the terms of the agreement, Sartorius Stedim Biotech will manufacture membrane adsorber technologies for GE, which will be marketed as part of GE’s ReadyToProcess product offerings.

Label Vision Systems (LVS) will be fully integrated into Microscan and the LVS name will become a brand within Microscan’s barcode label verification portfolio.

UPS joins the Global Health Supply Chain Technical Assistance program to help secure the drug supply chain.

The agency started the full operation of its medical literature monitoring on Sept. 1, 2015.

This special issue combines technical articles on leading pharma industry topics and a comprehensive preview of the upcoming CPhI Worldwide trade show

Pharma scientists announced for AAPS executive council and section leadership positions.

United Cargo signs global rental agreement with va-Q-tec for controlled transport of pharmaceuticals.

The Pre-Connect Congress will explore pharma industry trends, such as mergers and acquisitions, the biologics market outlook, and innovation in drug delivery among others.

Growth is said to be driven by the deeper penetration of biosimilars in developed and emerging markets as a result of clearer regulatory pathways.

Novo Nordisk plans to invest approximately $2 billion over the next five years in new production facilities in Clayton, North Carolina, US and Måløv, Denmark. The facilities are expected to be operational during 2020.

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.