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Here are a few brief news related to healthcare & pharmaceutical scenes for your update.

? FDA Granted Priority Review for New Anti-malaria Drug
? Australian Study Links Red Bull drink with Cardiovascular Risks
? FDA Once Again Postpones Approval of Prasugrel

 

? FDA Granted Priority Review for New Anti-malaria Drug
Novartis has announced that the FDA has granted priority review for Coartem, a fixed-dose combination of two antimalarials for malaria treatment worldwide. Recommended by the WHO and widely used in Africa, Coartem could become the first artemisinin-based combination treatment (ACT) approved for use by the FDA.
Coartem is said to be a highly effective 3-day malaria treatment that according to studies achieves cure rates of over 96% even in areas of multi-drug resistance.Currently approved in more than 80 countries, including 16 European nations, Coartem is said to be the only fixed-dose ACT that has been approved by internationally recognized stringent health authorities. In these countries, it is indicated for the treatment of acute uncomplicated infections due to plasmodium falciparum, the most dangerous form of malaria.
According to CEO of Novartis Daniel Vasella that Coartem has been used against malaria. Novartis has supplied 195 million treatments of Coartem without profit, helping to save the lives of close to 500,000 people suffering from malaria. Now Coartem has the potential to be the first ACT approved in the US.

 

 

? Australian Study Links Red Bull drink with Cardiovascular Risks
Researcher from the Cardiovascular Research Centre at the Royal Adelaide Hospital has found evidence that the popular stimulant energy drink Red Bull can increase the risk of heart attack or stroke, even in young people. The caffeine-loaded beverage, popular with university students and adrenaline sport fans to give them "wings," caused the blood to become sticky, a pre-cursor to cardiovascular problems such as stroke.
According to Scot Willoughby, the lead researcher told the press that one hour after they drank Red Bull, (their blood systems) were no longer normal. They were abnormal like we would expect in a patient with cardiovascular disease. This was the findings Willoughby’s  team inferred after tested the cardiovascular systems of 30 young adults one hour before and one hour after consuming one 250ml can of sugar-free Red Bull.
Red Bull is an energy drink created in the 1980s by Austrian entrepreneur Dietrich Mateschitz based on a similar Thai energy drink. One can contains 80 mg of caffeine, around the same as a normal cup of brewed coffee. Currently, it is banned in Norway, Uruguay and Denmark because of health risks.
The Austria-based entrepreneur is no stranger to endurance and extreme sports as Mr. Mateschitz himself bought the then struggling Jaguar Formula 1 racing team and it is now renamed as Red Bull F1 team which also took part in the recently completed inaugural F1 night race in Singapore on 28-Sep-08

 

 

? FDA Once Again Postpones Approval of Prasugrel
The much-anticipated FDA decision on prasugrel got some unexpected news: in a brief press statement released by Eli Lilly and Daiichi Sankyo right at the end of the day, the companies confirmed that the FDA would be missing its September 26 deadline in order to continue its review of the drug.
Prasugrel (marketing name Effient) is a novel platelet inhibitor developed by Daiichi Sankyo Co. and produced by Ube and currently under clinical development in cooperation with Eli Lilly for acute coronary syndromes planned for percutaneous coronary intervention (PCI).
Prasugrel is a member of the thienopyridine class of ADP receptor inhibitors, like ticlopidine (Ticlid) and clopidogrel (Plavix). These agents are believed to reduce the aggregation of platelets by irreversibly binding to P2Y12 receptors. Touted as the first real competitor to clopidogrel, The marketing approval was filed to FDA through priority review in January of this year and the initial review decision was slated for June 2008. But the FDA announced on June 26 that it would be postponing a decision for three months, in order to review additional analyses it has requested from the sponsors. Sep 26 has come and gone and it seems that further delays would be inevitable.

 

 

 

 

 

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