BioPharm International Editors

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

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.

Malvern Instruments' biophysical characterization equipment will be installed in a commercial applications laboratory in San Diego, California.

CMC Biologics and River Vision Development announce manufacturing agreement for RV001, a monoclonal antibody to treat Grave’s orbitopathy.

Cytovance Biologics Inc. announces development and manufacturing deal with NeuroFx for stem-cell-derived cell-free therapy for strokes.

ARGX-110-based combination therapies have demonstrated potential in treatment-resistant cancers.

The new biotech company, Mereo, is based in the United Kingdom, and kicks off with three mid-stage assets from Novartis.

Drug development is South Korea is being driven by the government’s R&D strategy under its Pharma 2020 Vision.

The contract is a memorandum of understanding for the manufacturing by MaSTherCell of clinical batches of TxCell’s Ovasave.

The collaboration will focus on advancing bi-specific antibodies that target hematologic and solid cancers, either as monotherapies or in combination regimens with other immune modulating treatments.

FDA’s quality metrics draft guidance details the types of data the agency plans to request and the quality metrics it plans to calculate.

EMA’s revised guideline on the implementation of accelerated assessment is open for public consultation.

The guidance provides recommendations for submitting analytical procedures and method validation data to FDA.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has announced a positive scientific opinion for GlaxoSmithKline’s (GSK’s) malaria candidate vaccine Mosquirix (RTS,S) for use outside of the European Union (EU) in children aged 6 weeks to 17 months.

The Catalent Applied Drug Delivery Institute and AAPS recognize four groups for emerging scientific talent and academic excellence.

FDA warns an Arkansas compounding company that it is in violation of the FDCA.

MedImmune will provide funding and in-kind contributions to support University of Sheffield research projects to address key challenges in cell engineering.

World Courier receives pharmaceutical storage and transportation accreditation in the United Kingdom.

Katsuaki Kaito has been named president of Shimadzu Scientific Instruments.

The decision makes Bristol-Myers Squibb’s therapy the first PD-1 checkpoint inhibitor approved in Europe.

The $19.7 million contract will assist Emergent with the development of cGMP lots of three Ebola mAbs.

CSafe and AES will support controlled-temperature shipping through the Basel, Switzerland airport from their new service center.

Biogen will take ownership of Eisai's Research Triangle Park manufacturing campus and will manufacture both oral solid-dose and parenteral drugs for Eisai.

Baxter has initiated a voluntary recall of two lots of IV solutions due to the potential presence of particulate matter.

The 2015 CPhI Pharma Awards honors innovation in all phases of small-molecule and large-molecule drug development.

Amoun, Egypt's largest drugmaker, will be sold to Valeant for $800 million.

FDA releases a report that analyses why some diseases are lacking treatment options.

The EMA, FDA, and EC met to plan collaboration on pharmaceutical drug development and evaluation.

The agency has released guidance on bioequivalence studies for asenapine, prasugrel, sitagliptin, and zonisamide.

Sanofi's new business-unit structure focuses on growth drivers.