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  Pharmaceutical Technology Europe E-Alert
 
9 July 2010
IN THIS ISSUE
API GMP changes
Roquette/SPI trial
Whistleblowers
Patent settlements
Changes ahead for EU GMP guide on APIs
Changes to Part 2 of the EU GMP guide will come into force by 31 July 2010 in order to bring it in line with the ICH Q9 guideline on Quality Risk Management. As a result, it will no longer be identical to the ICH Q7 guideline on APIs and is expected to include more requirements than the original text. More...
 
Trial date set for Roquette and SPI Pharma
Crunch time is rapidly approaching in Roquette’s long-running patent dispute with SPI Pharma, with the case scheduled to go to trial on 4th October 2010. More...
 
Drugmakers’ whistleblower policies investigated
A US senator has sent letters to 16 drugmakers, including Pfizer, AstraZeneca and Eli Lilly, asking them about their current policies regarding whistleblowers —employees who file complaints under the US False Claims Act — in a bid to improve the reporting of alleged fraud. More...
 
Drug industry criticizes US patent settlement provisions
The US House of Representatives has passed the Supplemental Appropriations Act of 2010, which includes provisions restricting patent settlements between innovator-drug and generic-drug companies, a move that has drawn criticism from both sectors of the pharma industry. More...
 
Read the July issue of Pharmaceutical Technology Europe
The latest issue includes a special feature on counterfeiting, as well as articles on pharmaceutical co-crystals and novel excipients. More...
 
Eli Lilly moves into enzyme replacement therapy
Eli Lilly has made a move into enzyme replacement therapy by acquiring Alnara Pharmaceuticals, whose pancreatic enzyme replacement therapy, liprotamase, is currently under review by the FDA for the treatment of exocrine pancreatic insufficiency. More...
 
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Latest articles
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2010 PDA/FDA Joint Regulatory Conference (13–16 September | USA)
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Product Profiles
Meggle Group
RetaLac® is a co-processed spray agglomerate consisting of equal parts of α-lactose monohydrate and hypromellose. RetaLac® is particularly designed for direct compression of modified release formulations.

Read more...

Event Profile
Smithers
TheExtractables & Leachables for Pharmaceutical Products 2010
Date: 14-15 September 2010
Venue: Holiday Inn London Kings Cross Bloomsbury, London

Impurities originating from any part of the manufacturing or storage of drug products can potentially result in expensive product recalls and damage to a company’s reputation, not to mention the serious threat posed to patient safety.

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Podcast
Vetter
The North American market is critical to Vetter’s strategic global growth as nearly half of its client base is already located here. In order to maximize on this opportunity, Vetter has decided to create a facility, its first outside of Germany, at the Illinois Science + Technology Park in suburban Chicago.

Read more...

 


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If your company was considering/is developing a biosimilar product, what would be your biggest concern?
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21%   Safety concerns
30%   Regulatory process
16%   Legal challenges
0%   Increased competition to innovative biologics
3%   The threat to biotech innovation
9%   No concerns; healthcare providers should have the option to prescribe a biosimilar

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