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European Filing & Registration Procedures
July 23, 2012–July 24, 2012
King of Prussia, Pennsylvania
Pharmaceutical Technology Presents Bio/Pharmaceutical Manufacturing Outsourcing
July 24, 2012–July 25, 2012
Philadelphia, Pennsylvania
Orphan Drug Summit
July 24, 2012–July 26, 2012
London, United Kingdom
REACH and CLP USA
August 1, 2012–August 2, 2012
Raleigh, North Carolina
Antibody-Drug Conjugates, Bispecifics & Empowered Antibodies
August 6, 2012–August 8, 2012
San Francisco, California
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BioStorage Technologies, a provider of sample-management solutions for the bioscience industry, including storage, cold-chain logistics, and virtual sample intelligence, is expanding its services to the Asia Pacific region. The expansion includes the appointment of Jason Huang as general manager of the region. BioStorage Technologies Asia Pacific will be headquartered in Singapore and will provide technical consulting in addition to a range of sample-management capabilities. Huang will be responsible for overseeing and managing the operations in Asia, identifying and developing new services, and driving overall business development and services growth in the region. 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 about pharmaceutical purification, purity, and impurity analyses at  www.agilent.com/lifesciences/realizepharma
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Bristol-Myers Squibb (BMS) has begun a cash tender offer to purchase all outstanding shares of common stock of Amylin Pharmaceuticals. Upon the successful closing of the tender offer, stockholders of Amylin will receive $31.00 in cash for each share of Amylin common stock validly tendered and not validly withdrawn in the offer, without interest and less any applicable withholding taxes. Following the purchase of shares in the tender offer, Amylin will become a subsidiary of BMS. BMS had previously announced its intention to acquire Amylin on June 29, 2012. Read More
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Maximize GC Headspace Productivity
Develop reliable testing for residual solvents with the Agilent 7697A Headspace Sampler injection system and maximize your precision, accuracy and throughput. Agilent’s method translation tools allow for conversion from other headspace samplers to deliver unparalleled confidence in your analytical results.  See the animated demo |
FDA has approved Gilead Sciences’s once-daily oral Truvada (emtricitabine; tenofovir disoproxil fumarate), a treatment to reduce the risk of sexually acquired HIV-1 infection in adults at high risk. As part of the approval, Gilead worked with the FDA to develop a Risk Evaluation and Mitigation Strategy to help ensure safe use of Truvada for pre-exposure prophylaxis as part of a comprehensive prevention strategy. Read More
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Ensuring Data Integrity: A Multi-Disciplinary Approach
August 9-10 New Brunswick, NJ
This CfPA intensive course will delve into concerns such as how to prevent data integrity problems, how to detect them and how to insure that they don't occur in the first place. Proper corrective actions, should data integrity Issues be detected, will also be addressed. Use Priority Code PT200 and Save $200 on tuition.  Read 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 ptpress@advanstar.com |
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FDA has indicated it is moving forward with a long-planned pilot to test ways to ensure the quality and integrity of imported pharmaceutical ingredients and finished products. The Secure Supply Chain Pilot Program was originally proposed in 2009 but generated concerns about excessive red tape and oversight. FDA has revised the program and is seeking final approval from the Office of Management and Budget to move forward. FDA’s plan is to select up to 100 manufacturers and importers that each submit information on how five drugs will be imported into the US. Applicants must maintain records documenting the product’s movement through their secure supply chain, meet customs requirements to guard against terrorism, and demonstrate that they comply with good importer practices proposed by FDA. Jill Wechsler covers this topic in the August 2012 issue of PharmTech.
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Unlocking the Power of New Softgel Technology for Multiple API Formulations
Live Webcast: Thursday, July 26, 2012 at 11:00 am EDT
Register Free at  http://www.pharmtech.com/apiformulations |
The European Medicines Agency is opening up its new pharmacovigilance legislation (EU No 1235/2010, Directive 2010/84/EU) for public consultation through Aug. 17, 2012. The legislation requires manufacturers to provide healthcare professionals with a summary of product characteristics that includes a statement and black symbol for drugs that are under additional monitoring for safety issues. Changes to patient information include the addition of a statement in the package leaflet encouraging patients and doctors to report to the national reporting system any possible side effects of the product that the patient experiences.
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Path to Zero Landfill: Learn How One Company is Leading the Way
Live Webcast: Tuesday, August 21, 2012, 11:00 am EDT
Register Free at www.pharmtech.com/landfill |
The Biologics & Biotechnology Monographs 1 Expert Committee of the United States Pharmacopeia (USP) is asking biotechnology companies with FDA-approved and validated bioidentity methods to participate in the USP’s modernization and verification of a new bioidentity test of Somatropin drug substances and products. USP plans to move the new test into a new USP chapter, General Chapter <126> Somatropin Bioidentity Tests. More information can be found on USP’s website.
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| GMPs for Method Validation in Early Development: An Industry Perspective (Part II) |
by: Donald Chambers, Gary Guo, Brent Kleintop, Henrik Rasmussen, Steve Deegan, Steven Nowak, Kristin Patterson, John Spicuzza, Michael Szulc, Karla Tombaugh, Mark D. Trone, and Zhanna Yuabova
IQ Consortium representatives explore industry approaches for applying GMPs in early development.
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Coming soon: Pharm Tech’s August issue will feature an interview on advances in solubility and formulation with Bend Research. |
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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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System reduces sample preparation for mass spectrometry
