Adeline Siew is editor for Pharmaceutical Technology Europe. She is also science editor for Pharmaceutical Technology.
First Biologic Approved in the EU for Gouty Arthritis
March 6th 2013Ilaris (canakinumab), a selective, fully human, monoclonal antibody that inhibits interleukin-1 beta (IL-1 beta), has been approved in the EU for symptomatic pain relief in patients suffering from gouty arthritis whose condition cannot be managed with current treatments.
Ablynx and Spirogen Collaborate on Novel Toxin-Nanobody Drug Conjugates
February 27th 2013Belgium drug developer Ablynx and UK-based Spirogen have entered into a research collaboration to discover and develop novel anticancer drug conjugates combining Spirogen's proprietary cytotoxic drugs, pyrrolobenzodiazepines (PBDs), and the company's associated linker technology, with nanobodies generated using Ablynx's proprietary technology platform.
Merck's Cilengitide Fails to Meet Primary Endpoint in Phase III Trial
February 25th 2013Merck's investigational integrin inhibitor cilengitide did not meet its primary endpoint in the CENTRIC Phase III trial evaluating if the agent could prolong overall survival when added to the current standard chemoradiotherapy regimen (temozolomide and radiotherapy).
First Commercially Available Intravenous Immune Globulin with a Thrombin Generation Assay Test
February 6th 2013Biotest Pharmaceuticals Corporation announced that Bivigam [immune globulin intravenous (human), 10% liquid] is now available in the pharmaceutical distribution channel for use by physicians, pharmacists and hospitals throughout the US. Bivigam is a sugar-free, glycine stabilized intravenous immune globulin that has been approved by the FDA in December 2012 for the treatment of patients with primary humoral immunodeficiency (PI).
Shire to Resolve Federal Investigation and Pay $57.5 Million
February 5th 2013Shire announced that it has reached an agreement in principle with the US government to resolve the previously disclosed civil investigation into its sales and marketing practices in the US relating to the company's attention deficit hyperactivity disorder (ADHD) drugs, Adderall XR and Vyvanse as well as the ADHD patch Daytrana.
Endo Pharmaceuticals and GVK Biosciences Form Research Collaboration
January 30th 2013Endo Pharmaceuticals and GVK Biosciences (GVK BIO), a contract research organisation (CRO) based in India, have entered into an agreement to collaborate on the development of small molecules targeting an undisclosed protein. Using its discovery expertise, GVK BIO will deliver a clinical candidate and Endo will be responsible for the development and commercialisation of the product.
Roche Collaborates on Stem Cell Project
December 12th 2012Roche and the Innovative Medicines Initiative (IMI) have recently launched an academic-industry partnership, known as STEMBANCC, under which 10 pharmaceutical companies and 23 academic institutions will collaborate on using stem cell technology to accelerate the development of safer and more effective drugs for patients.
Access to Clinical-Trial Data and Transparency Workshop
November 26th 2012The European Medicines Agency (EMA) recently conducted a workshop on clinical-trial data and transparency in London following the agency's decision to proactively publish all data from clinical trials and enable interested parties to access to full data sets.
Boehringer Ingelheim Licenses BaroFold's PreEMT High-Pressure Protein-Refolding Technology
November 23rd 2012Boehringer Ingelheim has entered into a non-exclusive technology and commercial license option agreement with BaroFold. Under the terms of the agreement, Boehringer Ingelheim will license BaroFold's pressure-enabled manufacturing technology (PreEMT).
Thermo Fisher Scientific Opens New Manufacturing Facility in China
November 20th 2012Thermo Fisher Scientific has officially opened its new manufacturing facility in Suzhou, China. The $20-million plant will manufacture life-sciences consumables and equipment as well as establish local production capabilities to meet increasing demand in China and other regions in Asia Pacific.