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EVENTS
Today
Berlin, Germany
Today
Berlin, Germany
22 March 2010
London, UK
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DIRECTORY Scrip Directory 2009
Merck/Portola's betrixaban shows bleeding benefit in Phase IIb
16 March 2010
Merck / Portola Pharmaceuticals ' investigational Factor Xa inhibiting anticoagulant betrixaban was associated with significantly less clinically relevant bleeding than warfarin when given at 40mg/day to patients with atrial fibrillation, show new results from a dose-finding study presented on March 15th at the American College of Cardiology (ACC) meeting in Atlanta. "The EXPLORE-Xa study accomplished its objective of providing important information to guide the betrixaban dosing strategy for ...
 
OSI eyes third party options after board rejects Astellas bid
16 March 2010
OSI Pharmaceuticals ' board has unanimously rejected Astellas 's unsolicited $52 per share cash offer for the company, recommending that OSI shareholders do the same. After a formal review, which included external advisors, the board's conclusion was that "the offer does not fully reflect OSI's ...
ThromboGenics hopes for transformational 2010
15 March 2010
ThromboGenics ' cash and investments grew to €76.7 million last year after its €42 million private placement in November. The balance will give ThromboGenics "the financial resources to continue to pursue [its] strategy of becoming a strong, profitable and integrated biopharmaceutical company", ...
 
Merck/Portola's betrixaban shows bleeding benefit in Phase IIb
16 March 2010
Merck / Portola Pharmaceuticals ' investigational Factor Xa inhibiting anticoagulant betrixaban was associated with significantly less clinically relevant bleeding than warfarin when given at 40mg/day to patients with atrial fibrillation, show new results from a dose-finding study presented on ...
ACCORD LIPID: Fenofibrates fail to improve cardiovascular outcomes type 2 diabetics
15 March 2010
Hypolipaemic fenofibrates such as Abbott s' TriCor, its next-generation Trilipix and generics, do not improve cardiovascular outcomes in patients with type 2 diabetes when used in combination with simvastatin (Merck & Co's lipid-lowering Zocor). The much-awaited ACCORD LIPID data were presented ...
 
US vaccine court again rejects MMR-autism link
16 March 2010
A special federal court, the US Court of Federal Claims, which was established to handle claims of injury from vaccines, ruled on 12 March that the mercury-containing preservative thimerosal in the measles-mumps-rubella (MMR) vaccine is not to blame for autism. Special Master George ...
Daiichi Sankyo sees new products, Ranbaxy taking sales to $12 billion level in three years
15 March 2010
Daiichi Sankyo is aiming to boost its group operating profit by almost 90% to ¥180 billion ($1.98 billion) in the fiscal year ending March 31st, 2013, on net sales which are seen reaching ¥1,150 billion, a 20% increase over those forecast for the year to this March 31st. Much of the projected ...
 
Genzyme plays down latest Cerezyme impurity
16 March 2010
Genzyme has just revealed that it found an impurity in a single vial of its Gaucher's disease drug Cerezyme (imiglucerase) from its fill-finish facility in Waterford, Ireland last December. However, it downplayed the problem, noting that the impurity was present at an extremely low level and in ...
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, ...
 
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 ...
 
Bioprojet's orphan drug for EDS enters Phase III trials
16 March 2010
The privately owned French biotech firm Bioprojet says that its new compound for excessive daytime sleepiness (EDS), pitolisant, has shown good results in several European Phase II trials and has now begun Phase III development. The product, which Bioprojet says is the first histamine H 3 receptor ...
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 ...
 
Daiichi Sankyo sees new products, Ranbaxy taking sales to $12 billion level in three years
15 March 2010
Daiichi Sankyo is aiming to boost its group operating profit by almost 90% to ¥180 billion ($1.98 billion) in the fiscal year ending March 31st, 2013, on net sales which are seen reaching ¥1,150 billion, a 20% increase over those forecast for the year to this March 31st. Much of the projected ...
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) ...
 
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 ...
 
Gene therapy-focused Genetix Pharmaceuticals raises $35 million
15 March 2010
Genetix Pharmaceuticals, which is developing gene therapies for genetic disorders, has raised $35 million in series B funds. The round included new investors Third Rock Ventures and Genzyme Ventures, with existing investors TVM Capital, Forbion and Easton Capital also participating. The proceeds ...
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 ...
 
EXPERT VIEW
EU must act to save its minor markets for medicines
15 March 2010
Faraz Kermani
The fact that many poor countries globally suffer as a result of the lack of access to life-saving ...

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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