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EVENTS
17 March 2010
Berlin, Germany
17 March 2010
Berlin, Germany
22 March 2010
London, UK
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DIRECTORY Scrip Directory 2009
US FDA advisory committees back randomised trials for LABA safety
12 March 2010
The US FDA was established in 1931, but only three years ago did it get the power to order drug makers to conduct safety studies of products that have already been approved and put into general use. Just how difficult it is going to be to use that authority became clear at a two-day joint meeting held on March 10th-11th of the agency's advisory committees on pulmonary and allergy drugs and on drug safety and risk management. The FDA was asking the outside experts to weigh in on how to ...
 
FDA panel backs InterMune's pulmonary fibrosis drug Esbriet despite reservations
10 March 2010
By a decisive 9-3 vote, the US FDA 's advisory committee on pulmonary drugs on March 9th recommended that the agency approve the new drug application (NDA) from InterMune to market as a treatment its drug Esbriet (pirfenidone) to reduce the decline in lung function in patients with idiopathic ...
Japanese recommendation moves alogliptin closer to the market
04 March 2010
An advisory committee to Japan's ministry of health, labour and welfare has recommended for approval Takeda 's oral antidiabetic, alogliptin. The positive opinion moves the DPP-4 inhibitor closer to what is likely to be its first market, following the delays in the US last year. Alogliptin has yet ...
 
Pfizer faces disappointment with anticancers after more Phase III failures
12 March 2010
Pfizer is facing more disappointment with the development of some of its most advanced anticancers after Sutent (sunitinib) failed two more Phase III trials in advanced breast cancer - ending development for the drug in the disease - and figitumumab (CP-751,871), one of the most advanced (IGF-1) ...
Europe to give €12 million for influenza antiviral projects
12 March 2010
The European Commission will provide €12 million in funding for two new research projects which will develop novel influenza treatments, including against both (A) H1N1 pandemic influenza and (A) H5N1 avian flu. Speaking at an EU influenza meeting in Venice, Italy, this week the Commission said the ...
 
FDA panel backs InterMune's pulmonary fibrosis drug Esbriet despite reservations
10 March 2010
By a decisive 9-3 vote, the US FDA 's advisory committee on pulmonary drugs on March 9th recommended that the agency approve the new drug application (NDA) from InterMune to market as a treatment its drug Esbriet (pirfenidone) to reduce the decline in lung function in patients with idiopathic ...
FDA criminal division may increase misdemeanour prosecutions against execs
10 March 2010
The US FDA may in the future look to increase prosecution of "responsible corporate officials" in both the pharmaceutical and food industry, Commissioner Margaret Hamburg has stated in a letter, which followed a scathing new government report citing a severe lack of oversight in how the agency ...
 
US FDA advisory committees back randomised trials for LABA safety
12 March 2010
The US FDA was established in 1931, but only three years ago did it get the power to order drug makers to conduct safety studies of products that have already been approved and put into general use. Just how difficult it is going to be to use that authority became clear at a two-day joint meeting ...
Avastin fails only Phase III trial in advanced prostate cancer
12 March 2010
Roche 's Avastin (bevacizumab), the world's best-selling cancer drug, has failed to prolong overall survival in its only Phase III trial in advanced prostate cancer, CALGB 90401, which was sponsored by the US National Cancer Institute (NCI). Roche said it was analysing the data to determine the ...
 
Europe to give €12 million for influenza antiviral projects
12 March 2010
The European Commission will provide €12 million in funding for two new research projects which will develop novel influenza treatments, including against both (A) H1N1 pandemic influenza and (A) H5N1 avian flu. Speaking at an EU influenza meeting in Venice, Italy, this week the Commission said the ...
Medivation/Pfizer's disappointing Dimebon data sends Alzheimer's hopes, and shares, crashing
04 March 2010
Medivation / Pfizer 's experimental Alzheimer's disease drug Dimebon (latrepirdine), failed to differentiate from placebo and met none of its endpoints, show top-line results of the first Phase III efficacy trial, dashing the hopes of doctors, patients and analysts alike. Although Medivation's ...
 
Ark withdraws EU brain cancer filing for Cerepro and starts strategic review
09 March 2010
Ark Therapeutics has withdrawn the EU filing of its brain cancer gene therapy candidate Cerepro (sitimagene ceradenovec), dropping a previous appeal over a negative opinion from the CHMP. It has at the same time initiated a full strategic review of its business and is in discussions with a number ...
Japanese recommendation moves alogliptin closer to the market
04 March 2010
An advisory committee to Japan's ministry of health, labour and welfare has recommended for approval Takeda 's oral antidiabetic, alogliptin. The positive opinion moves the DPP-4 inhibitor closer to what is likely to be its first market, following the delays in the US last year. Alogliptin has yet ...
 
EXPERT VIEW
Paediatric medicines - don't forget the excipients
12 February 2009
Peter Charlish
In recent years there has been a growing realisation that many drugs used in children have not, for ...

Market Insight - Power of observation propels comparative effectiveness research into the mainstream
02 March 2010

US agencies are making inroads in the use of comparative effectiveness research to support more ...

 Market Insight: Big pharma hit by Greece's fi...
 How to run clinical trials in the Middle East...

Market Insight - Fear gives way to prudence as VCs eye return of bull biotech market
19 February 2010

2009 was a bad year for investment in the biotech sector, with venture capital funds fleeing to ...

Market Insight - Microdosing reaching a tipping point?
05 February 2010

Advocates of microdosing, a technique that involves testing very small doses of products in humans, ...

Genzyme's gambit: A hedge against Carl Icahn
18 February 2010
Christopher Spillane
The fall in Genzyme 's share price made it an obvious target. The Massachusetts based biotech ...

European Medicines Agency and logos: snakes, DNA and the pestle and mortar
22 December 2009
Elizabeth Sukkar
Logos are said to be an important part of an organisation's branding. Really good logos contribute ...

The art of targeting cancer therapies: an interview with Professor Paul Workman
15 September 2008
Malini Guha
Whilst there have been many successes in Professor Paul Workman's 30-year career in cancer drug ...

Focus on Controlled-Release Therapies
09 July 2008
New life from controlled-release - With days to go before the 35th Annual Meeting of the Controlled ...

Pipeline Watch
26 June 2009
This week’s table shows the continued roll out of Servier’s melatonergic antidepressant Valdoxan ...

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