Biosimilars Market Worth $3.7 Billion by 2015

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April 5, 2011 News New Challenges for Use of Embryonic Stem Cells Amy Ritter The National Institutes of Health’s definition of embryonic stem cells poses new challenges for investigators who seek federal research funding. More Biosimilars Market will be Worth $3.7 Billion by 2015 Stephanie Sutton The global market for biosimilars is set to grow from $243 million in 2010 to $3.7 billion in 2015, according to research from Datamonitor. More AstraZeneca Agrees to $1.1-Billion Settlement to US and UK Tax Authorities Patricia Van Arnum AstraZeneca has been informed that the UK and US governments’ tax authorities have agreed to the terms of an advance-pricing agreement regarding transfer-pricing arrangements for AstraZeneca’s US business for the 13-year period from 2002 to the end of 2014. More Sanofi Issues Bonds to Fund Genzyme Acquisition Erik Greb On Mar. 23, 2011, sanofi-aventis offered $7 billion in notes to fund its acquisition of Genzyme. The notes are offered in six tranches scheduled to come due between 2012 and 2021. More Remember when you thought you could do anything? Now you can. Purification is complex; so is your process. With a complete suite of Clarification, Chromatography and Ultrafiltration products for every scale, backed by applications knowledge and support, you'll have the confidence you need to be a Purification superhero http://www.millipore.com/thepurifiers Discovery Pipeline New tuberculosis vaccine candidate Scientists from the Imperial College of London have identified a protein secreted by tuberculosis (TB) bacteria that stimulates a strong immune response in humans, and is specific to TB bacteria, making it a promising candidate for a new vaccine (Proceedings of the National Academy of Sciences). More Delivering siRNA to the brain Exosomes—endogenous nano-vesicles that transport RNAs and proteins, can deliver short interfering (si)RNA to the brain in mice when delivered systemically. This finding offers the potential for treating CNS disorders with siRNA therapies (Nature). More Heart damage improves after stem-cell injections Researchers demonstrate benefits of stem cell therapy in a small clinical trial of patients with enlarged hearts due to heart attacks. Patients treated with stem cells showed a decrease in heart size, decrease in scar tissue and improved heart function (Circulation Research). More The innovative technologies Sartorius provides for research and development in industry and the public sector are focused on solutions for sample preparation, instrumental analysis, cell cultivation, quality control and data management. If desired, we can also offer you support with a customized service schedule tailored to fit your requirements in your routine lab work. Learn more Company/People Notes Boehringer Ingelheim formally acquired Amgen’s biopharmaceutical development and manufacturing facility in Fremont, California. This acquisition involves leasing buildings, acquiring physical equipment, and assuming manufacturing processes done at the Fremont site. The facility currently employs more than 300 employees and consists of more than 200,000 feet2 for laboratories, manufacturing, and process development suitable for clinical and market supplies. The purchase agreement was signed in January 2011. JHP Pharmaceuticals, a provider of contract manufacturing services for sterile injectable products, has entered into a multiyear contract-manufacturing agreement with an undisclosed biotechnology company. JHP will be responsible for manufacturing and supply of a sterile liquid product used in processing biologics. Real-Time Scheduling of Biopharmaceutical Operations APRIL 14, AT 1-2PM PACIFIC TIME Biopharmaceutical manufacturing equipment and labor are expensive, finite and often shared across multiple processes. In this webinar we will describe the limitations of the today's mostly simplistic Microsoft Project-like scheduling tools and why these result in sub-optimal plans (along with a continued reliance on Excel). We will provide real-world examples of a way to schedule biomanufacturing plant operations in real time using Bio-G's Simulation platform, which takes account of the complexity of the process, the finite and shared nature of facility resources, plus the need for split-second re-scheduling. Please click below to participate in our complementary webinar at http://info.bio-g.com/webinar/RTS.html Lonza, a contract development and manufacturing organization, has formed an agreement with biopharmaceutical company Athera Biotechnologies. Lonza will initiate cell line and process development for Athera’s monoclonal antibody PC-mAb. Athera’s PC-mAb is intended for the treatment of patients with acute coronary syndrome who are at an increased risk of secondary cardiovascular events and death. This agreement secures a development and cGMP manufacturing plan for Athera. Lonza will initiate cell line and process development using Lonza’s GS Gene Expression System. Merck & Co. and the biopharmaceutical company Portola Pharmaceuticals have announced that Merck plans to return to Portola all rights for betrixaban, an investigational oral Factor Xa inhibitor anticoagulant being evaluated for the prevention of stroke in patients with atrial fibrillation. Merck KGaA has agreed to acquire the microbiology business of Biotest, a company specializing in immunology and hematology. This business consists of heipha Dr. Müller GmbH, located in Eppelheim, Germany, as well as the Hycon business located in Dreieich, Germany, the subsidiaries in France, Japan, and the US as well as further activities and employees in several European countries. Closing of the transaction is expected in the second half of 2011.The acquisition allows the Merck Millipore division to complete its product portfolio in industrial microbiology for contamination detection. Specifically, the business will add to Merck Millipore’s existing dehydrated cell-culture media and testing systems the so called “ready-to-use” culture media and instruments. ©2009, Advanstar Communications, Inc. 224 Phillip Morris Drive, Suite 402 Salisbury, MD 21804   Follow Biopharm International on Twitter! Contact us / Feedback Biopharm International The Magazine Risk-Analysis Tools in Process Validation of Biopharmaceutical Drugs Read More Coming soon! Don't miss our special issue this month on Separation and Purification. www.BiopharmInternational.com Events Apr 11-15: 2011 PDA Annual Meeting San Antonio, TX Registration details Apr. 13-14: PDA Workshop: The FDA's Process Validation Guidance San Antonio, TX Registration details May 3-4: Assessing Packaging and Processing Extractables/Leachables Bethesda, MD Registration details Jobs Clinical Chemist/Toxicologist Dallas, TX More Information Director, Project Management -Translational Research - Columbia Columbia, MD More Information Vice President, Head of Sales Fort Lauderdale, FL More Information

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