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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.
Roche and BioLamina Collaborate on Novel Cell Culture Systems
March 6th 2013Roche and BioLamina have entered into a research and development agreement to jointly develop new cell culture systems for various applications, including stem cell research. The collaboration will assess laminin-based in-vitro cell culture matrices that can offer physiological microenvironments for living cells.
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.
Affymax and Takeda RecallAll Lots of OMONTYS (peginesatide) Injection
February 25th 2013Affymax Inc. and Takeda Pharmaceutical Company Limited have decided to voluntarily recall all lots of OMONTYS (peginesatide) Injection to the user level as a result of new postmarketing reports regarding serious hypersensitivity reactions.
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).
Promise—and Problems—Signal Mixed Year Ahead for Big Pharma
February 19th 2013Biopharmaceuticals-the major source of new medicines and a key knowledge industry for the future-faces another rough year from empowered payers as it makes its slow passage to a renewed product base. This is the main finding from Pharmaceutical Executive magazine's annual survey of trends and issues facing the biopharma world in the year ahead.
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.