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European Pharmaceutical Pricing & Reimbursement
October 29, 2012–October 30, 2012
London, United Kingdom
The New FDA/EU Approach to Process Validation
October 30, 2012–October 31, 2012
Barcelona, Spain
Virus and TSE Safety Made Simple
October 30, 2012–October 31, 2012
Heidelberg, Germany
Innovation Excellence Workshop
October 30, 2012–October 31, 2012
Berlin, Germany
PDA Pharmaceutical Quality System (ICH Q10) Conference
November 5, 2012–November 6, 2012
Tokyo, Japan

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AstraZeneca and Ironwood Pharmaceuticals have agreed to codevelop and cocommercialize Ironwood’s linaclotide in China. Linaclotide is a guanylate cyclase-C (GC-C) agonist approved by FDA, in August 2012, for treating irritable bowel syndrome with constipation and chronic idiopathic constipation. The companies are jointly responsible for strategic oversight of the development and commercialization of linaclotide in China. AstraZeneca will have primary responsibility for the local operational execution. Under the collaboration, AstraZeneca will make an upfront payment of $25 million to Ironwood and will share the net profits and losses associated with linaclotide in China, with AstraZeneca carrying 55% until a certain specified milestone is achieved, moving to a 50/50 split thereafter. Ironwood will also be eligible for $125 million in additional commercial milestone payments, contingent on the achievement of certain sales targets. Read More
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Handheld Raman Accelerates Raw Material Release
Enwave Optronics introduces the NEW ASSUPx Handheld Raman Analyzer for raw material verification. Most materials are measured and evaluated within 15 seconds. The ASSUPx is fully 21 CFR Part 11 compliant for GMP requirements. It is an ideal choice for pharmaceutical, industrial chemicals and applications requiring high speed, reliable Raman analysis.
Enwave Optronics, Inc.
http://www.enwaveopt.com/EZRaman-H.htm |
Catalent Pharma Solutions has launched the Catalent Applied Drug Delivery Institute to promote innovation, knowledge-sharing, and collaboration between industry leaders, academic experts, customers and regulators to enhance understanding of available, emerging, and future drug-delivery technologies and improve patient care. As part of its mission, the Catalent Applied Drug Delivery Institute will serve as a link between industry and academia by providing guidance, counsel, and resources on major issues pertaining to drug development, delivery, and formulation. The Institute will develop programs that facilitate mutually beneficial collaborations, increase communication, and shed light on regulatory issues affecting drug developers and researchers. It also will pursue a multitiered approach of seed funding, strategic counsel, and educational programs to advance the adoption of emerging technologies. Catalent announced the launch of the institute at the 2012 American Association of Pharmaceutical Scientists (AAPS) Annual Meeting and Exposition in Chicago earlier this month. Read More
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Caron's Photostability Chambers ideal for forced degradation
Caron's Photostability chambers feature a benchtop size and are designed in accordance with ICH Q1B guidelines. Uniform light distribution and high intensity levels allow for quick response forced degradation testing and confirmatory studies. To learn more and to download our white paper "Using Photostability Chambers to Meet the Requirements of Drug Testing in Accordance with ICH, Q1B" visit www.caronproducts.com/photostability |
Pfizer has announced its intention to acquire NextWave Pharmaceuticals, a privately held specialty pharmaceutical company focused on the development and commercialization of products for the treatment of attention deficit/hyperactivity disorder (ADHD) and related central nervous system disorders. NextWave is the developer of Quillivant XRTM (methylphenidate hydrochloride) for extended-release oral suspension, CII, a once-daily liquid medication approved in the US for the treatment of ADHD. NextWave holds exclusive North American commercialization rights to Quillivant XR. Quillivant XR received approval from the FDA on Sept. 27, 2012, and is expected to be available in pharmacies in the US in January 2013. Read More
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Realize Effective Pharmaceuticals
Reliable solutions enable pharmaceutical scientists to innovate in disease research, accelerate drug discovery and have greater confidence throughout development and manufacturing. Agilent solutions in genomics research, automation, separation and detection technologies along with workflow driven software solutions helps deliver the answers to bring effective therapeutics to market.
Learn more at www.agilent.com/lifesciences/realizepharma |
The biotechnology company Seattle Genetics has expanded its antibody-drug conjugate (ADC) collaboration with Abbott. Under the expanded deal, Abbott will pay an upfront fee of $25 million for rights to use Seattle Genetics’ auristatin-based ADC technology with antibodies to additional oncology targets. In addition, Seattle Genetics may receive up to $220 million in potential milestone payments per additional target upon achieving predetermined development and commercial objectives, as well as mid-to-high single-digit royalties on worldwide net sales of any resulting products under the multitarget collaboration. Read More
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Agilent ICP-MS/ICP-OES
Reliable solutions for regulated pharmaceutical laboratories
Complying with new elemental impurity limits as defined by draft USP methods <232>/<233> could pose a significant challenge. You need to choose qualified hardware and software, ensure verification, and maintain electronic records. But there is a simple answer – Request a free copy of our primer on Elemental Impurity Analysis to learn more. |
A roundup of additional company and people news from pharmaceutical and biopharmaceutical companies, their suppliers, and contract-service providers. Read More
Do you have news to report on facility expansions, contracts, service agreements, mergers, acquisitions, or personnel appointments? Send press releases to [email protected] |
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Janet Woodcock, MD, director of FDA’s Center for Drug Evaluation and Research, announced on Oct. 24, 2012, in an FDA blog, the launch of the Coalition for Accelerating Standards and Therapies (CFAST), a partnership between FDA, the Clinical Data Interchange Standards Consortium (CDISC), and the Critical Path Institute (C-Path). The partnership intends to bring clinical data experts together to “develop data standards tailored to individual diseases and therapeutic areas” and provide opportunities to transform data from drug studies on specific diseases to get new therapies to patients quicker.
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Best Practices for Achieving Product Quality in Sterile Manufacturing
Live Webcast: Tuesday, November 6, 2012 at 11:00am–12:00pm EST
Register Free at www.pharmtech.com/achieving |
“Standardized data elements that are common to all clinical trials, such as age and gender, have been established using CDISC terminology. However, data elements that are unique for a particular disease or therapeutic area still need to be developed so that the data from multiple trials can be more easily grouped for reporting and analysis,” said Woodcock. “We believe that CFAST will provide an important resource for drug development and research that will result in enhancements in the evaluation of safe and innovative therapies for the public.”
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API Development: Risk Evaluation and Control of Genotoxic Impurities
Live Webcast: Thursday, November 8, 2012 at 10:00am EST
Register Free at www.pharmtech.com/genotoxic |
FDA Commissioner Margaret A. Hamburg, MD, issued a statement on Oct. 24, 2012, in response to the fungal meningitis outbreak, stressing the importance of the partnership between federal, state, and local authorities in dealing with public health issues. "The FDA has been working closely with the CDC and public health officials in Massachusetts and other states to investigate the scope and cause of the outbreak. In fact, both agencies have been working hand-in-hand with our colleagues in every state affected by this outbreak," said Hamburg.
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Overcoming Formulation Challenges of Parenteral Drugs
Live Webcast: Tuesday, October 30, 2012 from 11:00 AM EST to 12:00 PM EDT
Register Free at www.pharmtech.com/parenteral |
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Integration of Less-Formal Risk Assessment Tools into Change Control |
by: Kelly Waldron, Marissa Gray
Managing risk in biopharmaceutical operations is of utmost importance for patient protection.
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Coming soon: Pharm Tech’s November issue will explore mean kinetic relative humidity and its relationship with moisture-sensitive pharmaceuticals. |
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Please take a moment to complete Pharmaceutical Technology's annual employment survey, and tell us about your job—tell us how satisfied you are, and what you hope to find in the job market in the future.
Results of the survey will be published in the December 2012 issues of Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International. Those completing the survey will be entered to win one of three $100 Amazon.com gift certificates.
Thanks for your participation!
From the Editors of Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International.
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Know Before You Go—2012 Conference Previews
Visit our Show & Exhibition Gateway 2012 to see which companies are exhibiting at upcoming industry conferences.
Find company backgrounds, new product releases, booth materials, and more.
PharmTech's online
Gateway is your guide to the season's leading shows.
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