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CPhI Worldwide
October 9, 2012–October 11, 2012
Madrid, Spain
2012 AAPS Annual Meeting and Exposition
October 14, 2012–October 18, 2012
Chicago, Illinois
The Universe of Prefilled Syringes & Injection Devices
October 15, 2012–October 17, 2012
Las Vegas, Nevada
PDA's 7th Annual Global Conference on Pharmaceutical Microbiology
October 22, 2012–October 24, 2012
Bethesda, Maryland
ICH Q9 Training Course
October 24, 2012–October 25, 2012
Vienna, Austria ICH Q10 Training Course
October 25, 2012–October 26, 2012
Vienna, Austria 
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Ablynx and a Merck & Co. subsidiary have agreed to develop and commercialize Nanobody candidates directed toward a voltage gated ion channel with the option to develop and commercialize a Nanobody to a second target. Under the agreement, Merck gains exclusive global rights to Nanobodies against the selected target, with an option for similar rights to a second target. Upon signing, Merck will pay Ablynx a EUR 6.5-million ($8.4 million) upfront payment and a EUR 2-million ($2.6 million) fee for research funding. In addition, Ablynx will be eligible to receive up to EUR 448 million ($580 million) in research, regulatory, and commercial milestone payments associated with the progress of multiple candidates as well as tiered royalties on any products derived from the collaboration. Ablynx will be responsible for the discovery of Nanobody candidates and Merck will be responsible for the research, development, manufacturing, and commercialization of any Nanobody product resulting from the collaboration. 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
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Catalent Pharma Solutions has established a global alliance with Parexel International to help streamline the clinical-trial supply process. The alliance will provide a fully integrated service offering aimed at ensuring the timely and efficient delivery of clinical-trial materials. 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 |
In other news, Catalent has agreed to supply to the biopharmaceutical company Vivus Qsymia once-daily combination extended-release capsules. Qsymia was recently been approved by FDA as a once-daily combination treatment for chronic weight management in adults who are obese or overweight with a weight-related comorbidity. 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
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Janssen Biotech has entered into a license agreement with Astellas Pharma for the worldwide development and commercialization, except in Japan, of ASP015K, an oral, small-molecule Janus Kinase inhibitor. ASP015K is currently in Phase II-b development as a once-daily treatment for rheumatoid arthritis, following a successful Phase II-a study demonstrating its potential in the treatment of moderate-to-severe plaque psoriasis. Read More
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Property of SEMBIOSYS GENETICS INC – IN RECEIVERSHIP SemBioSys Genetics Inc. is a development stage agricultural biotechnology company. MNP Ltd. is seeking offers to purchase the right, title and interest of SBS in all intangibles, including patents, trademarks, copyrights and other intellectual property of SBS and of all safflower seed inventories of SBS, and the intellectual property imbedded therein.
Visit www.mnpdebt.ca/
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SAFC, part of Sigma-Aldrich, plans to expand its operations in Scotland by investing in the development of a new powder-manufacturing facility on its Irvine site. SAFC’s new facility in Irvine is its second powder manufacturing facility, which will support SAFC’s risk-management program, providing an internal back-up supplier for its customers. The new facility will be used to service customers across Europe and will create 24 new jobs. The project is being supported by a £1.5-million ($2.42 million) Regional Selective Assistance grant from Scottish Enterprise. Read More
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Increasing your chances for success in First-In-Man studies
Live Webcast: Wednesday, October 3, 2012 at 11:00 AM EDT. Register Free at www.pharmtech.com/success
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A roundup of additional company and people news from pharmaceutical and biopharmaceutical companies, their suppliers, and contract-service providers. Read More
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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 |
Do you have news to report on facility expansions, contracts, service agreements, mergers, acquisitions, or personnel appointments? Send press releases to ptpress@advanstar.com |
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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 |
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FDA has launched BeSafeRx—Know Your Online Pharmacy, a national campaign designed to promote public awareness of fraudulent Internet pharmacies. The program offers consumers resources for educating themselves on FDA’s website at www.fda.gov/BeSafeRx. FDA warns that fake online pharmacies use sophisticated marketing tricks and that “less than 3% of online pharmacies meet state and federal laws.” FDA recommends consumers only purchase from online pharmacies located in the United States that require a valid doctor’s prescription, have a licensed pharmacist available, and are licensed with a state board of pharmacy.
FDA has released the following guidance documents:
Guidance for Industry, Acute Bacterial Otitis Media: Developing Drugs for Treatment (September 2012).
Guidance for Industry, Acute Bacterial Exacerbations of Chronic Bronchitis in Patients With Chronic Obstructive Pulmonary Disease: Developing Antimicrobial Drugs for Treatment (September 2012).
Guidance for Industry, Complicated Intra-Abdominal Infections: Developing Drugs for Treatment, Draft Guidance (September 2012).
Guidance for Industry, Initial Completeness Assessments for Type II API DMFs Under GDUFA, Draft Guidance (October 2012).
On Oct. 1, 2012, the European Medicines Agency announced publication of the “EURD list,” a list of European Union reference dates and frequency of submission of periodic safety update reports. The EURD list includes active substances and combinations of active substances in drugs that are subject to different marketing authorizations.
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Weighing Access and Affordability |
by: Kenneth I. Kaitin and Joshua P. Cohen
Policymakers must balance fundamental issues involving access to medicines and pricing.
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Coming soon: Pharm Tech’s November issue will feature a biologics manufacturing marketing overview. |
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Solubilization Solutions
In a special PharmTech issue, current and emerging bioavailability challenges are examined. Articles address solutions and approaches for solubilization as related to solid dispersions by hot-melt extrusion, lipophilic excipients, lipid-based formulations, spray drying, and more. Read More
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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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