Pharmaceutical Technology Europe E-Alert


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29 October 2010

IN THIS ISSUE
• Genzyme and Sanofi
• FDA DDT guidance
• EU drug development pilot
• Offshore tax concerns



Genzyme says it is worth more than Sanofi bid Genzyme has outlined why it believes sanofi-aventis’s tender offer of $69 per share “dramatically undervalues the company” and why a price of $89 per share would be more reflective of the company’s true value. More...

FDA issues draft guidance for qualifying drug development tools The FDA has issued draft guidance that offers a framework for submitters of drug development tools (DDT) to interact with officials at the FDA’s Center for Drug Evaluation and Research regarding data needed to support qualification. More...

Europe launches early drug development pilot A European pilot initiative will test the impact of consultations with a number of stakeholders such as patient representatives and payers on early stage drug development. More...

PhRMA raises concern about tax initiative in Puerto Rico A fiscal reform package has been announced in Puerto Rico that calls for the reduction of individual and corporate tax rates, but a measure to impose a tax on offshore manufacturers has drawn criticism from the pharma industry. More...

Life sciences protected in the UK The UK’s coalition government has unveiled its spending review and it’s good news for the life sciences sector, which has been allocated annual public funding of £4.46 billion ($7 billion) until 2014/2015. More...

Join our community on LinkedIn Want to discuss any of this week’s news stories or any other hot topics in the industry? Then why not join our group on LinkedIn? More...

Latest blog posts

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Peer-reviewed research

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Upcoming events

EMBALLAGE (22–25 November | France)

2010 Pharmaceutical Freeze Drying Technology: Modern Trends in Production (23–24 November | Austria)

Qualified Person Forum 2010 (25–26 November | UK)

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Product Profile

Oxoid

Media Fill Trials
Oxoid Cold filterable Tryptone Soya Broth has been specially developed to meet the increasing regulatory demands of undertaking aseptic process validations (media fills). This highly filterable medium allows new guidelines to be met, and aseptic process simulations without the need for heating or changing filters.
Read more...

Oxoid

BioProcess Containers
Oxoid Cold filterable Tryptone Soya Broth that just plugs into processing lines for your media fills trials. Made with WFI quality water, each batch comes with quality certification. No media preparation, no QC, just less stressful media fills to get your production lines running as efficiently as possible.
Read more...

Elan

Elan Drug Technologies, the world’s leading drug delivery business, delivers clinically meaningful benefits to patients by using our extensive experience and proprietary delivery technologies in partnership with pharmaceutical companies to develop new and innovative products.
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Shimadzu

Powerful team for excellent separation and Design Space modeling DryLab & Shimadzu UHPLC.
Shimadzu, one of the leading manufacturers in analytical instrumentation, and the Molnár Institute in Berlin, Germany, cooperate in applying DryLab2010 software and the new generation of Shimadzu UHPLC instruments.
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Recruitment Profile

Council of Europe

"Vacancy notice for a selection procedure open to nationals of Council of Europe member states
Read more...

Vacancy notice for a selection procedure open to nationals of Council of Europe member states
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Event Profile

Chemspec Middle East

29-30 November 2010
Dubai World Trade Centre
Dubai, UAE.

The region’s first fine and specialty chemicals event, Chemspec Middle East is part of a natural progression for the Chemspec Events brand as the Gulf region continues to develop in many industries beyond its traditional oil, gas and petrochemical sectors.
Read more…

What is the biggest challenge to implementing cleanroom conditions?

Regulations		4%
Validation		16%
Facility Design		18%
Personnel training		30%
Cleaning and maintenance		18%
Equipment cost		14%

This week we would like to know...

FDA Commissioner Hamburg recently discussed the creation of user fees for the generic-drug sector. Do you support the proposal?

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