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THE MAGAZINE

28 May 2010

IN THIS ISSUE
• Genzyme surrenders profits
• Generic and hybrid medicines
• FDA public disclosure
• Reader survey
• Printing APIs



Genzyme to surrender $175 million Genzyme has signed a consent decree that requires the company to correct manufacturing quality violations at its Allston (MA, USA) facility and will also provide the federal government with $175 million, which Genzyme made in unlawful profits. More...

Generic and hybrid applications 60% higher than estimates Fifty percent of the marketing authorization applications for human medicines submitted to the European Medicines Agency (EMA) in 2009 were for generic and hybrid medicines — 60% higher than the agency’s forecast. More...

FDA's proposes public disclosure policies The FDA’s Transparency Task Force has published a series of proposals on public disclosure policies as part of its initiative to help the industry and the public better understand how the agency works. More...

Take part in PTE's short reader survey What are we getting right and what can we improve upon? Give your opinion of Pharmaceutical Technology Europe by taking part in a short survey and be in with the chance of winning an iPod Touch! More...

GSK believes in the power of printing APIs A collaboration involving GlaxoSmithKline and two British universities is looking to create faster acting medicines with a technology that prints APIs onto a tablet’s surface. More...

Abbott to acquire Piramal’s Healthcare Solutions business Signaling its interest to strengthen its presence in emerging markets, Abbott has agreed to acquire Piramal Healthcare Ltd.’s Piramal Healthcare Solutions business (domestic formulations) for $3.72 billion. More...

*Join PTE* on LinkedIn!** Join Pharmaceutical Technology Europe's group on LinkedIn. More...

Product Profile

Center for Professional Advancement

Access Training You Need Now
With over 100 Live and On-Demand Online Training courses, and nearly 300 instructor led courses to choose from - CfPA’s Accredited courses can ensure you receive the skills and knowledge that will make a difference in your career. Register now for: IQ/OQ/PQ Dublin 10 Feb, Root Cause Investigation for CAPA Dublin 24 Feb, or Effective FDA Submissions 12 Feb Online. .

Product Profile

Dishman

Dishman Group has successfully completed the trial production of its new China facility. The trial was done during the second week of May 2010. Consequently, Dishman plans to inaugurate the new multi-product cGMP facility at the beginning of July 2010.

Product Profile

Shimadzu

Shimadzu's TOC-V series covers all water quality analysis requirements. Two systems within this series are particularly suitable for TOC analysis in pharmaceutical applications.

Event profile

9th Annual Biological Production Forum 2010

21st - 23rd June 2010
Sheraton Frankfurt Hotel & Towers
Frankfurt, Germany

9th Annual Biological Production Forum 2010 is the event focusing on both upstream and downstream processing for biological manufacturing, production and cGMP specialists. Over the course of this 3 day event, you will take part in a mixture of networking and conference session featuring the latest strategies and industry case studies.

Event profile

Chemspec 2010

June 9-10, 2010
Messe Berlin, Germany

After the success of Chemspec Europe in Barcelona, Berlin is a natural choice as the destination for Chemspec Europe 2010. Germany is at the heart of the European fine and speciality chemicals market and the third largest chemical producer in the world making it an ideal destination for Chemspec Europe to celebrate its 25th anniversary.

Key Topic Updates

Latest blog posts

The US treasury shows R&D scientists some love

When is it enough? More of FDA’s resources should go to pediatrics

Some recalled infants tylenol had too much acetaminophen

More blog posts

Latest articles

Do emerging markets provide the answer to the pharmaceutical industry?

Change management: common failures and a checklist for improvement

REACH: Has the cloud of confusion cleared?

More latest articles

June events

How to pass EU and FDA inspections & GMP compliance auditor course (8 June | Germany)

Packology (8–11 June | Italy)

Chemspec Europe (9–10 June | Germany)

More events

To encourage innovation in excipients, do you think FDA should review novel excipients outside of a new drug application?

■		Yes 88%
■		No 13%

This week we would like to know...

Which anti counterfeiting solution is your company currently using?

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