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Podcasts

Webcast: Screening Methods for Elemental Impurities: Proposed Compendial Requirements
June 14, 2012—Sponsored by SGS Life Science Services

Webcast: When Softgels Are a Good First Option: Overcoming Bioavailability Challenges
June 12, 2012—Sponsored by Patheon

Webcast: Meeting New USP Method Transfer Requirements
May 15, 2012—Sponsored by SGS Life Science Services

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

MORE WEBCASTS

Podcast: Asset Accuracy: Know What You Have and What It's Worth

Podcast: Single-Use Pumps in Biologicals Production

Podcast: What You Should Know About Lean Six Sigma Initiatives

Podcast: Drug Delivery Insights

MORE PODCASTS

Events

PDA Chemistry Manufacturing & Controls (CMC) Workshop
May 14, 2012
Bethesda, Maryland

Global Clinical Trials Outsourcing Summit
May 14, 2012—May 15, 2012
Seoul, South Korea

Sixth International Pharmaceutical Compliance Congress
May 14, 2012—May 16, 2012
Budapest, Hungary

PDA FDA Virus and TSE Safety Conference
May 15, 2012—May 17, 2012
Bethesda, Maryland

Pharma Outsourcing & Procurement Summit 2012
May 21, 2012—May 22, 2012
Berlin, Germany

More events


FindPharma Search
May 10, 2012 PharmTech.com

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News

FDA Issues Final Rule on Sterility Testing of Biologics
FDA issued a final rule on sterility testing on May 3, 2012, which amends the requirements for most licensed biological products and aims to provide manufacturers with the flexibility, as appropriate, to keep pace with technological and scientific advances. Many steps are changed or eliminated.
Click Here to Read More

Sanofi Gains Regulatory Approval for Expansion at Site in Ireland
Sanofi has received FDA and EMA approval for expansion of fill and finish operations for alglucosidase alfa.
Click Here to Read More

Abbott Reaches Settlement Agreement on Depakote
Abbott Laboratories will pay $1.6 billion to settle outstanding issues concerning past sales and marketing practices for its neurologic medication, Depakote.
Click Here to Read More

EFPIA Advances Medicines Verification Project
The European Federation of Pharmaceutical Industries and Associations has formally adopted a memorandum of understanding with key partners for a harmonized, European system for medicines verification.
Click Here to Read More


Product Spotlight

Biosensor provides high-throughput capabilities

SAW Instruments’s samX acoustic biosensor is designed to provide enhanced workflow flexibility and a high-throughput capability for applications involving the analysis of molecular interactions on cellular surfaces. The device uses SAW’s proprietary surface acoustic wave technology to detect mass binding and protein-conformational changes on whole cells. The company’s range of sam acoustic biosensors also offers real-time analysis using viable cells while eliminating the need for molecular labeling.

The samX features two sensor chips, rather than the single chip in SAW's existing sam5 models, and incorporates eight analysis channels. The biosensor also contains advanced fluidic system and each channel can be used independently or via combinations of 4 x 2, 2 x 4, or 1 x 8 channels, offering a highly flexible workflow. In addition, different ligands can now be automatically immobilized on-line at each chip position via the fluidics, thus eliminating the need for off-line protein loading while providing more accurate and reliable results.


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Company Notes

Daiichi Sankyo and the biopharmaceutical company Coherus BioSciences have agreed to develop and commercialize biosimilar forms of etanercept and rituximab in several Asian countries, including Japan. Under the terms of the agreement, Daiichi Sankyo and Coherus BioSciences will work together to develop, manufacture, and commercialize biosimilar forms of etanercept and rituximab developed by Coherus BioSciences. Upon marketing approval, Daiichi Sankyo will commercialize these products in Japan, South Korea, and Taiwan. Coherus has retained all additional development and commercial rights outside of the licensed territories. Read More

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How-to Video Series: Tablet Press Setup
Get the most from your processing equipment by learning how to properly setup your tablet press. Natoli's newest "how-to" video series demonstrates the correct way to setup your tablet press with step-by-step tooling installation instructions. If you want to get the most from your tablet press and tooling, you can't afford to miss this must-see video series!
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The China-based investment group of Johnson & Johnson (J&J) has acquired Guangzhou Bioseal Biotech, a privately held biopharmaceutical company specializing in the design, development, and commercialization of a porcine plasma-derived biologic product for controlling bleeding during surgery. The acquisition was completed after obtaining all necessary Chinese Government approvals. Guangzhou Bioseal Biotech manufactures a porcine-derived fibrin sealant, Bioseal, currently the only porcine plasma-derived fibrin sealant approved for use in China. Guangzhou Bioseal Biotech will work with Ethicon, a J&J subsidiary. Read More

Advertisement:
Rapid Micro Biosystems is pleased to announce the 2013 availability of two new applications leveraging the Growth Direct™ technology. The Growth Direct™ Systems for Environmental Monitoring and Sterility Testing provide automated, non-destructive, rapid analysis and detection based on proven technology. Sample preparation mirrors the existing steps with positive results in hours and final reporting in half the time of traditional methods.
http://www.rapidmicrobio.com/news/bid/85479/Rapid-Micro-Biosystems-announces-the-2013-availability-of-Growth-Direct-Systems-for-Environmental-Monitoring-and-Sterility-applications

Sandoz, a subsidiary of Novartis, has agreed to acquire specialty dermatology generic-drug company Fougera Pharmaceuticals for $1.525 billion. The acquisition is subject to customary closing conditions and regulatory approval. Read More

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Industry Briefs:

A roundup of additional company and people news from pharmaceutical and biopharmaceutical companies, their suppliers, and contract-service providers. Read More

Advertisement:
Pharmaceutical Technology Presents Bio/Pharmaceutical Manufacturing Outsourcing
Build Strategic Partnerships • Improve Technology Transfer • Mitigate Risk
July 24-25, 2012 Philadelphia, PA

In this focused, interactive forum, bio/pharmaceutical executives come together with contract manufacturing organizations to discuss strategies for effective operations, quality oversight and risk mitigation. Join your colleagues to hear the latest regulatory trends, learn best sourcing practices and identify business opportunities in the outsourcing arena.
Register by June19th at http://www.cbinet.com/outsourcing and save $300 with priority code: AMS592

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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CBI's Biopharmaceutical Forum on Clinical and Commercial Global Supply Chain Excellence
Ensure End-to-End Integrity and Adapt to Fit Regulatory, Market and Operational Needs
July 24-25, 2012 * New Brunswick, NJ * Hyatt Regency New Brunswick
This conference brings together the clinical and commercial supply teams for thought sharing on intersecting issues while still addressing unique challenges during tracked (clinical/commercial) sessions. Hear organizational strategies and learn how industry peers are managing the diverse supply chain network including cross functional-teams, suppliers, global/virtual teams etc.
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PharmTech, the magazine
Current Issue cover
Meeting Manufacturing Challenges Tied to Extended-Release Injectables
by: Angie Drakulich
Industry experts working with extended-release injectables discuss challenges and solutions to formulating and manufacturing these complex products.
Click Here to Read More

Coming soon: Coming soon: Pharm Tech's June issue analyzes the market of monoclonal antibodies, recombinant proteins, and vaccines in contract biologics manufacturing.


Advertisement:
Meeting New Method Transfer Requirements
Live Webcast: May 15, 2012 at 11:00 AM EDT for North America and May 22, 2012 at 11:00 AM CET for Europe
Register Free at http://www.pharmtech.com/method

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 backgrounders, new product releases, booth materials, and more. Let PharmTech's online Gateway be your guide to the season's leading shows.


Advertisement:
When Softgels Are a Good First Option: Overcoming Bioavailability Challenges
Live Webcast: Tuesday, June 12, 2012 at 11:00 am ET
Register Free at http://www.pharmtech.com/softgels

 

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Significant Changes
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