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cGMP Quality Principles for Pharmaceuticals, Biopharmaceuticals, Biologics and Medical Devices
August 27, 2012–August 29, 2012
Los Angeles, California
3rd Annual Pharmacovigilance 2012
August 31, 2012
Mumbai, India
2012 Inhalation and Nasal Technology Focus Group (INTFG) Annual Fall Symposium – Hosted by Gateway Analytical
September 7, 2012
Pittsburgh, Pennsylvania
Royal Pharmaceutical Society Annual Conference 2012
September 9, 2012–September 10, 2012
Birmingham, United Kingdom
2012 PDA/FDA Joint Regulatory Conference
September 10, 2012–September 12, 2012
Baltimore, Maryland 
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Eli Lilly Receives $1.3 Billion Following Bristol-Myers Squibb's Acquisition of Amylin Pharmaceuticals
Eli Lilly has received $1.3 billion for payment of financial obligations from Amylin Pharmaceuticals following Bristol-Myers Squibb’s acquisition of Amylin Pharmaceuticals earlier this month.
Myriad Genetics Receives Favorable Ruling on Gene Patentability
Myriad Genetics reported that a US federal appeals court has ruled that the company’s composition of matter claims covering isolated DNA of the BRCA1 and BRCA2 genes are patent-eligible material under federal patent law. The court, however, denied the company's effort to patent methods of “comparing” or “analyzing” DNA sequences.
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Ropack provides solid dose packaging services to leading pharmaceutical and healthcare companies. Operating in 250,000 square feet, Ropack is equipped for humidity- and temperature-sensitive production and packaging of stick-packs. Other services include blister, bottle and pouch, powder blending and encapsulation and in-country clinical trial packaging and distribution management. Ropack has the capacity, technology and resources to grow your business. Contact:paul.dupont@ropack.com
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Grey-Market Distributor Convicted of Defrauding FDA
South Carolina-based Altec Medical pleaded guilty to one count of conspiring to defraud FDA and to commit federal offenses in connection with a drug-diversion scheme that lasted from 2007 to 2009.
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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 |
GlaxoSmithKline Divests Brands in Australia for $271 Million
GlaxoSmithKline (GSK) is selling the majority of its so-called ‘classic brands’ in Australia to Aspen Global for approximately £172 million ($271 million) in cash. GSK expects the divestment to be completed in the fourth quarter of 2012, subject to regulatory approvals.
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Advances in Label-Free Technology (Video) –  Click to Watch
Watch this customer success story as told by GSK in this video. Learn how you too can unlock challenging targets, simplify assay design, and shorten time to results with the Agilent RapidFire System. In this video, GSK presents the findings from their studies using the RapidFire High-throughput Mass Spectrometry System in various stages of the lead discovery process.
Re-Imagine Mass Spectrometry Throughput Watch the Video |
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 Tablet press expedites changeover times
Fette Compacting America's FE35 Tablet Press offers one of the fastest changeover times in its class. Its single-rotary design allows the machine to be fitted with up to 51 stations, enabling the production of up to 367,000 tablets per hour. The machine is assembled with detachable, FDA-certified polymer panels and offers 360-degree access.
The FE35's direct torque drive offers energy-efficient, zero-maintenance operation. To increase flexibility, a switch cabinet can be positioned internally or externally, and the machine's power cabinet features an innovative cooling design. A fast, easy turret changeover set-up includes cams and punches and is segmented to permit expedient refitting. Other turret features include a coded tablet scraper and coded filling cam detection, as well as a central, multifunction connector for oil, air, and electricity.
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Astellas Pharma Tech has announced plans to expand its facility at the Takahagi Technology Center (Japan) with a new GMP-compliant building with a total floor area of approximately 4170 m2 (44,885 ft2). The building will be equipped with flexible facilities capable of supporting a multiple lineup of manufacturing items and changes in volumes based on demand of investigational drug substance. The facility is estimated to cost JPY 4.2 billion ($53 million) and is expected to be completed in late July 2013. Read More
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Analytical Methods Validation for FDA Compliance
September 19-21 New Brunswick, NJ. Use Priority Code PT200 and Save $200.
Whether involved in method development, method validation, method verification or method transfer, this CfPA course will provide a broad understanding and “hands-on” knowledge of the method validation process and the difficulties encountered in validating methods to comply with today’s upgraded FDA CDER requirements.  Read More |
FDA has extended the action date by three months for Pfizer’s new drug application for tofacitinib, an investigational oral treatment for adults with moderately to severely active rheumatoid arthritis. According to Pfizer, FDA determined that additional data analyses recently submitted by the company constitute a major amendment to the application and will require additional time to review. FDA has not asked that Pfizer complete any new studies. The FDA has provided an anticipated Prescription Drug User Fee Act date of Nov. 21, 2012. Read More
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Atypical Visible Particles (Black Specks): Approaches for Manufacturers and Users
Live Webcast: Thursday, September 13, 2012 at 11:00 AM EST
Register Free at  www.pharmtech.com/atypical |
The biopharmaceutical company Regulus Therapeutics has entered into an alliance with AstraZeneca to discover, develop, and commercialize microRNA therapeutics for three exclusive targets that are currently in preclinical development. The targets are focused on cardiovascular and metabolic diseases and oncology. Under the agreement, AstraZeneca will make a $28-million payment which includes an equity investment and an upfront payment to Regulus. Read More
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Path to Zero Landfill: Learn How One Company is Leading the Way
Live On Demand Webcast
Register Free at  www.pharmtech.com/landfill |
Additionally, Regulus has formed a collaboration with Biogen Idec to identify microRNAs as biomarkers for multiple sclerosis (MS). Under the transaction, Biogen Idec will make an investment in Regulus in addition to upfront and milestone payments. The key objective of the collaboration is to identify microRNA biomarkers in the blood of patients with MS. Read More
In other news, Regulus has filed a registration statement on Form S-1 with the US Securities and Exchange Commission relating to a proposed initial public offering of shares of its common stock. All shares of the common stock to be sold in the offering will be offered by Regulus. The number of shares to be offered and the price range for the offering have not yet been determined. Read More
United Drug, a provider of healthcare services, has agreed to acquire the clinical-services company Bilcare Global Clinical Supplies from Bilcare Limited for a total consideration of $61 million. The acquisition is expected to be completed on Aug. 31, 2012, and is subject to customary closing conditions. As part of the agreement, Bilcare Limited will retain its clinical supplies business in Asia. 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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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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