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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
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) receptor antagonists in development, failed a second Phase III trial in advanced non-small cell lung cancer (NSCLC). "Sunitinib has been thoroughly evaluated in advanced HER-2 negative breast cancer, ...
 
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) ...
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 ...
 
Philippines makes more medicine price cuts for pharma
09 March 2010
The Philippines government has announced a second wave of price cuts in the medicines sector under the government-mediated access price (GMAP) programme. Most reductions will come into effect on March 31st, while others will be implemented at a later date when supply issues have been addressed. ...
BMS expects 9-13% decline in EPS after Plavix genericisation
05 March 2010
Bristol-Myers Squibb expects its minimum projected non-GAAP EPS to be at least 9% lower in 2013 than its projected 2010 figure, as the loss of patent exclusivity to its lead product, the blood thinner Plavix (clopidogrel), takes full effect. The company expects 2013 EPS to be at least $1.95, ...
 
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 ...
India reports 741 polio cases in 2009
11 March 2010
India has reported 741 cases of polio in 2009 (up from 559 in 2008), with the two states of Uttar Pradesh and Bihar reporting the bulk of these. As of February 26th this year, the country had reported 16 cases of the enterovirus. Uttar Pradesh reported 602 cases of polio last year and eight up to ...
 
BMS expects 9-13% decline in EPS after Plavix genericisation
05 March 2010
Bristol-Myers Squibb expects its minimum projected non-GAAP EPS to be at least 9% lower in 2013 than its projected 2010 figure, as the loss of patent exclusivity to its lead product, the blood thinner Plavix (clopidogrel), takes full effect. The company expects 2013 EPS to be at least $1.95, ...
Antidiabetic GLP-1s only linked to thyroid cancer in rodents, study suggests
05 March 2010
Thyroid cancer risks of anti-diabetic GLP-1 analogues are probably limited to rats and mice, suggests Novo Nordisk -sponsored research published this week in the journal Endocrinology. Investors, who had been expecting the good news, nevertheless breathed a sigh of relief for the emerging ...
 
FDA continues "safety review" of potential link between bisphosphonates and fractures
11 March 2010
The US FDA has announced an "ongoing safety review" of oral bisphosphosphonates to see if they are potentially linked to atypical subtrochanteric femur fractures, or fractures in the bone just below the hip joint. For the data reviewed to date, there is no clear connection, the regulator said. An ...
Amgen's Prolia beats Zometa in final Phase III bone metastases trial
09 February 2010
Amgen's Prolia (denosumab) was superior to Novartis's bisphosphonate Zometa (zoledronic acid) in delaying bone complications in prostate cancer patients with bone metastases, show top-line Phase III data. Before the data was announced, Jefferies analysts commented that positive data from this ...
 
Actelion needs to provide more info to FDA for Zavesca in Niemann-Pick disease
12 March 2010
The US FDA has issued Actelion with a complete response letter for its drug Zavesca (miglustat), for the treatment of progressive neurological manifestations in adults and children with Niemann-Pick type C (NP-C) disease – a rare, fatal neurodegenerative genetic disorder. The FDA has requested ...
PTC Therapeutics/Genzyme's ataluren fails in Phase IIb muscular dystrophy trial
11 March 2010
PTC Therapeutics and Genzyme 's ataluren, an experimental nonsense mutation suppressor, has failed in nonsense mutation Duchenne/Becker Muscular Dystrophy (nmDBMD), show top-line Phase IIb results. Around 10-15% of DBMD cases are due to nonsense mutations. Despite the failure, Dr Langdon Miller, ...
 
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) ...
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 ...
 
GSK's RLS setback has XenoPort halving workforce
09 March 2010
XenoPort is shedding 50% of its workforce and shelving its discovery research efforts following the "unexpected setback" in the approval of Horizant (XP13512; gabapentin enacarbil extended release tablets), which is under development with GlaxoSmithKline in the US to treat restless legs syndrome ...
AstraZeneca to exit specialist areas
03 March 2010
AstraZeneca is to stop research in several core areas as it strives to improve its R&D efficiency and cut costs. Newly released details of the restructuring, which was first revealed at its financial results meeting in January, show that it will also include a number of site closures worldwide. In ...
 
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 ...
FDA continues "safety review" of potential link between bisphosphonates and fractures
11 March 2010
The US FDA has announced an "ongoing safety review" of oral bisphosphosphonates to see if they are potentially linked to atypical subtrochanteric femur fractures, or fractures in the bone just below the hip joint. For the data reviewed to date, there is no clear connection, the regulator said. An ...
 
EXPERT VIEW
Keeping the faith with anticancers
12 March 2010
Peter Charlish
It has been a bad week for anticancer drug development, with two late-stage projects coming to ...

How to run clinical trials in the Middle East - why the GCC?
04 March 2010

A grouping of Middle Eastern countries came together under the auspices of the Gulf Co-operation ...

How to run clinical trials in the Middle East - Qatar
04 March 2010

With a population of only 835,000, Qatar's GDP per capita is $103,500 and its healthcare spend ...

How to run clinical trials in the Middle East - introduction
04 March 2010

The attractions of the Middle East as a location for clinical research include patient diversity, ...

Private investment round-up: January 2010
16 February 2010
Private investments began 2010 in a much more positive fashion than at the start of 2009, but were ...

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 ...

Face to Face with Sandoz's "growth guy" Jeff George
04 March 2010
Eleanor Malone
Jeff George took over as head of Sandoz, Novartis's generics business, in late 2008. With a big ...

Focus on Oncology
23 May 2008
Cancer drugs - the economic challenge. Karol Sikora assesses the extent to which health technology ...

Nycomed targets Russia for future expansion
18 June 2009
Sita Shah
Russia has suffered more than most countries in the current economic crisis, with GDP growth rates ...

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