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Podcasts

Webcast: Scale up and Manufacturing Challenges of Controlled-Release Parenteral Drugs
May 15, 2012—Sponsored by Evonik Industries

Webcast: What's the matter with Sample Prep? - Novel approaches and solutions
April 24, 2012—Sponsored by Mettler Toledo AG

Webcast: Making Sense of Excipient Performance for Quality by Design (QbD)
April 19, 2012—Sponsored by Colorcon

Webcast: Risk Management in Sterile Manufacturing
April 12, 2012—Sponsored by DPT

MORE WEBCASTS

Podcast: Drug Delivery Insights

Podcast: What You Should Know About Lean Six Sigma Initiatives

Podcast: DCAT President Discusses Industry Trends and Association Activities

Podcast: Informex Roundup

MORE POCASTS

Events

Pharmaceutical Strategic Outlook
April 11, 2012—April 13, 2012
New York, New York

2012 PDA Annual Meeting
April 16, 2012—April 18, 2012
Phoenix, Arizona

World Congress of Cardiology
April 18, 2012—April 21, 2012
Dubai, United Arab Emirates

10th EGA International Symposium on Biosimilar Medicines
April 19, 2012—April 20, 2012
London, United Kingdom

LogiPharma
April 24, 2012—April 26, 2012
Geneva, Switzerland

More events


FindPharma Search
April 5, 2012 PharmTech.com
News

GPhA Urges Congress to Move Ahead on Generic-Drug and Biosimilar User Fees
On Mar. 29, 2012, the Generic Pharmaceutical Association reiterated its call for Congress to move forward with user-fee proposals for generic drugs and biosimilar products.
Click Here to Read More

Ranbaxy Begins Shipping Generic Lipitor From Indian Facility
Ranbaxy Laboratories announced that beginning in March 2012, the first shipments of atorvastatin, the generic version of Pfizer’s Lipitor, had been sent to US markets from its new Mohali manufacturing facility located in Punjab, India.
Click Here to Read More

EMA Gets Tough on Conflicts of Interest
The management board of the European Medicines Agency has introduced a range of new measures to strengthen and extend its conflicts of interest policy for scientific-committee members and experts, as well as for members of the management board.
Click Here to Read More


Product Spotlight

Mass spectrometer measures dissolved gases and vapors

The HPR-40 Membrane Inlet Mass Spectrometer from Hiden Analytical has a new range of flow-through, semi-permeable interfaces designed to measure dissolved gases and vapors in liquid media that flows across or against the membrane surface. Interfaces designed for specific applications are continually being developed as needs arise. The HPR-40 can be used with flowing samples (using the circular membrane inlet), with single static samples (using the single probe membrane interface), or for multistream sampling (using 4-, 8-, 20-, 40-, and 80-way selectors). The HPR-40 benchtop system includes control and data analysis programs, and multistream samplers have automated, user-programmable sequencing.

Company Notes

Amgen and AstraZeneca have agreed to jointly develop and commercialize five monoclonal antibodies from Amgen's clinical-inflammation portfolio (AMG 139, AMG 157, AMG 181, AMG 557 and brodalumab (AMG 827)). Under the agreement, AstraZeneca will make a one-time $50-million upfront payment, and the companies will share both costs and profits. Based on current plans, approximately 65% of costs for the 2012–2014 period will be funded by AstraZeneca. Afterwards, the companies will split costs equally. Amgen will book sales globally and will retain a low single-digit royalty for brodalumab and a mid single-digit royalty for the rest of the portfolio, after which the companies will share profits equally. Read More

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Quantitative Determination of Genotoxic Impurities Using Xevo TQD
Xevo TQD is the only integrated system in its class that enables simultaneous acquisition of high quality quantitative and qualitative data from the widest range of experiments. This application note demonstrates a rapid, simple and powerful approach to genotoxic impurity identification at the Threshold of Toxicological Concern (TTC) using the Xevo TQD when used in a qualitative manner with the ASAP Probe and product ion confirmation (PIC). Learn More…

Fujifilm Diosynth Biotechnologies has completed the first phase of a £3-million ($4.5 million) investment in new equipment and laboratories at its Billingham, United Kingdom, site. The investment includes a complete refurbishment of its microbial fermentation laboratory, which has been totally refitted, including eight new in-situ sterilizable 20-L Sartorius Stedim Biotech fermenters, and several Dasgip parallel benchtop high-throughput units. In addition, a new suite of R&D laboratories has been installed for process development work, with a corresponding increase in the company's R&D workforce by 50 to more than 150 in the last 12 months. Read More

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For active and passive transdermal drug delivery contract manufacturing, contact Tapemark http://www.tapemark.com/transdermal.html

Takeda Pharmaceutical has announced that its Corporate Strategy & Planning Department and Finance & Accounting Department will jointly be reorganized to form two new departments, named the Corporate Strategy Department and the Corporate Finance & Controlling Department, effective Apr. 1, 2012, with its newly announced heads reporting to the president & CEO directly. Read More

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INTERPHEX™ New York May 1-3, 2012 - Javits Convention Center - New York, NY INTERPHEX™ is the leading annual pharmaceutical and biopharmaceutical trade show. Key decision makers find the networking opportunities, products, services and information they need to ensure quality and maximize efficiency, agility, and flexibility that solve manufacturing and supply chain problems. Find out more at http://www.interphex.com/AT.
 

Teva Canada has finalized an agreement under which the CMO Halo Pharmaceutical will acquire Teva's Mirabel, Quebec, Canada, manufacturing facility. The transaction is subject to approval by the Competition Bureau, successful negotiation of manufacturing agreements between Teva Canada and Halo, and receipt of manufacturing permits from various authorities. The closing of this transaction is currently scheduled for June 30, 2012. Read More

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Podcast - Process Validation for Sterile Manufacturing
Join William (JR) Humbert, the Validation Manager at Cook Pharmica, as he discusses the 2011 FDA Guidance for the Industry, Process Validation: General Principles and Practices, and the impact the guidance has for biotechnology and pharmaceutical companies performing sterile manufacturing process validation.

Industry Briefs:

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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Risk Management in Sterile Manufacturing
LIVE WEBCAST:Thursday, April 12, 2012 from 2:00 PM - 3:00 PM EDT
Register Free at http://www.pharmtech.com/dpt
 

Do you have news to report on facility expansions, contracts, service agreements, mergers, acquisitions, or personnel appointments? Send press releases to [email protected]

PharmTech, the magazine
Current Issue cover
Powder Testing Techniques for Tablet Manufacture
by: Tim Freeman, Jamie Clayton
This article considers the different conditions to which the powder is subjected in the tableting process, and discusses which powder properties should be measured to accurately reflect likely powder behavior in the process.
Click Here to Read More

Coming soon: Coming soon: Don’t miss our parenteral drug-manufacturing coverage in Pharm Tech’s May issue.


 
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