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Podcasts

Webcast: Bioavailability Enhancement Using Lipid-Based Drug Delivery
June 20, 2012—Sponsored by Catalent Pharma Solutions

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

Webcast: Applying Quality by Design in Tablet Coatings
June 13, 2012—Sponsored by Colorcon

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

MORE WEBCASTS

Podcast: Navigating Transdermal Outsourcing: Points to Consider When Seeking a Transdermal Drug Delivery Manufacturing Partner

Podcast: Breathe Easy: Expert Advice for Selecting the Right Manufacturing Partner for Inhalation Drug Delivery

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

Podcast: Single-Use Pumps in Biologicals Production

MORE PODCASTS

Events

Social Media in the Pharmaceutical Industry
July 9, 2012–July 10, 2012
London, United Kingdom

2nd Infectious Diseases World Summit
July 9, 2012–July 10, 2012
San Francisco, California

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

More events


FindPharma Search
June 28, 2012 PharmTech.com
News

Roche to Close US R&D Site
Roche Pharmaceuticals announced that it will be closing its R&D site in Nutley, New Jersey, eliminating approximately 1000 positions.
Click Here to Read More

FDA Updates List of Warning Letters
FDA has updated its website to include the latest Warning Letters issued to pharmaceutical companies by the Office of Prescription Drug Promotion and the Center for Drug Evaluation and Research.
Click Here to Read More

Advertisement:
Pharmaceutical starches from Grain Processing Corporation (GPC) range from basic unmodified starches for tableting to very specialized, innovative starches for unique applications.  Spress® Pregelatinized Corn Starches NF perform as binders, disintegrants and lubricants for granulations, direct-compression tablets, capsules, dry blends and roller compaction.  PURE-COTE® film-forming starches are designed for coating applications, oral thin films, capsules and any applications where clear, flexible films are required. Read more

EMA Investigates Roche for Deficiencies in Safety Reporting
The European Medicines Agency has launched an investigation into Roche after an inspection found that thousands of potential safety reports, including 15,161 deaths, connected to Roche medicines had not been evaluated to determine whether they should be reported to regulators as adverse drug reactions.

Click Here to Read More

EMA Finalizes Pharmacovigilance Guidelines
The European Medicines Agency has published its first set of finalized guidelines concerning good pharmacovigilance practices. The guidelines are a key deliverable of Europe's pharmacovigilance legislation, which will come into effect on July 2, 2012.

Click Here to Read More

Advertisement:
Handheld Raman Accelerates Raw Material Release
Enwave Optronics introduces the NEW ASSUPx Handheld Raman Analyzer for raw material verification. Most materials are measured and evaluated within 15 seconds. The ASSUPx is fully 21 CFR Part 11 compliant for GMP requirements. It is an ideal choice for pharmaceutical, industrial chemicals and applications requiring high speed, reliable Raman analysis.
Enwave Optronics, Inc.
http://www.enwaveopt.com/EZRaman-H.htm

Product Spotlight

Software monitors user compliance with enterprise applications

Knoa Software’s Knoa Experience and Performance Manager (EPM) version 7.0 is an end-user monitoring technology that helps companies enforce the best practices needed to maintain compliance with enterprise applications. The software supports SAP enterprise software, including the SAP NetWeaver Portal, the SAP Customer Relationship Management (SAP CRM) application, and SAP BusinessObjects solutions. Knoa EPM monitors the entire SAP solution-based landscape, analyzes in detail the user’s interaction with the application, and provides remediation recommendations so that users can take immediate action.

Company Notes

Adventrx and Patheon have entered into a manufacturing agreement under which Patheon will formulate, fill, and finish ANX-188 drug product for use in clinical trials, including the Phase III study of ANX-188 that AdventRX plans to initiate this year. Read More

Advertisement:
Ropack, provider of solid dose contract packaging services, celebrates its 35th anniversary by expanding its production campus to nearly 250,000 sq. ft. The fully licensed site adds 36,000 sq. ft. of validated ambient and cold storage warehousing as well as five new Class 100000 clean rooms – bringing Ropack's total clean rooms to 32 – to accommodate increasing customer needs.Contact: Paul Dupont, [email protected]  www.ropack.com

Bend Research and Catalent Pharma Solutions have agreed to provide services for pharmaceutical companies seeking to develop and manufacture specialized multiparticulate oral controlled-release products. Under the agreement, the companies will provide an integrated approach designed to bring complex controlled-release products to market faster and more efficiently with optimal therapeutic and release profiles. Read More

Advertisement:
Ensure Consistent Compliance
Confidence means using better science for more consistent compliance. Agilent Enterprise Edition uses a direct, automated approach to consistently perform qualification testing, validate calculations, and harmonize reports. Ensure your consistent, cost-effective compliance and reduced regulatory risk with Agilent Enterprise Edition.
Visit www.agilent.com/chem/comply

Merck Serono and Compugen, a therapeutic product-discovery company, has established Neviah Genomics, a start-up company focused on the discovery and development of novel biomarkers for the prediction of drug-induced toxicity. Neviah Genomics will be operating out of the Merck Serono Israel Bioincubator. Merck Serono Ventures will provide the initial funding for Neviah Genomics. Compugen will use certain proprietary predictive discovery technologies and receive an equity ownership in the new company and a right to royalties from potential future sales. Read More

Advertisement:
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

The CRO Quintiles has agreed to establish a regional headquarters in Shanghai, to significantly expand laboratory-testing capabilities in China. Under a joint venture agreement, Quintiles will engage Shanghai Clinical Research Center to provide laboratory-testing services to local customers. To provide the infrastructure essential for its growth strategy in China, Quintiles is investing $14 million to establish a new 4000-m2 (43,000 ft2) headquarters in Shanghai to serve China and nearby Asian countries. Read More

Advertisement:
Get a Working Knowledge of All Aspects for Effective Packaging
Attend CfPA’s training course July 26-27 for an intensive look at how all types of packaging are developed, manufactured, tested, filled, transported, stored and used. Emphasis placed on the characteristics of packaging materials which can influence the packed product; protection, compatibility, safety, compliance, design, performance on the filling and closing lines, distribution, marketing and use. Read More

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

Advertisement:
Come to the BIO International Convention, June 18-21, 2012, Boston, Mass., for the connections, partnerships and innovations to get business done. Join 15,000+ biotech leaders for a BIO Program offering perspectives on issues and a BIO Exhibition with 1,800+ companies showcasing the latest technologies and services. BIO One-on-One Partnering™ makes it easy to set up face-to-face meetings in the BIO Business Forum and the BIO Exhibition. http://convention.bio.org

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


Advertisement:
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
PharmTech, the magazine
Current Issue cover
GMPs for Small-Molecule Drugs in Early Development (Part I)
by: Amnon Eylath, Brent Kleintop, Tony Mazzeo, James S. Mcelvain, Andy Rignall, John Skoug
IQ Consortium representatives explore and define common industry approaches and practices for applying GMPs in early development.
Click Here to Read More

Coming soon: Don't miss a look at the industry then and now: a time capsule of readers' views, in Pharm Tech's 35th anniversary issue in July.

 

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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PharmTech Poll

Affordable Care Act
Are you in favor of the US Supreme Court overturning the Affordable Care Act and its associated biosimilars pathway?

Vote here
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On Our Blog PharmTech Talk

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Deficiencies in Roche Safety Reporting

Industry Conferences, Manufacturing
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