Friday 15 August 2008

Edinburgh festival classical music review: Ysa�e Quartet

The odor of coffee tree, and a Haydn quartet: hard not to feel that the first daybreak chamber concert of the Edinburgh International festival was offering an oasis of civilisation in an otherwise chaotic city. The Ysa�e Quartet too supplied music to stir up the einstein up. Even the Haydn was unlawful: the C major Quartet, Op 54 No 2, which, with its through-composed middle movements and slow, serene closing curtain, subverts the usual classical pattern.












For most, nevertheless, the find will have been Szymanowski's Quartet No 2, written in 1927. Its endorsement and third base movements register the composer in proudly Polish mode: the former is a rough-edged dance driven as if by clockwork, the latter grows out of a contemplative folk-like psychogenic fugue. But the first effort is the most intriguing. It begins with a whispered, poker-faced buzz from the inner instruments, spell the low gear violin and cello tissue an angular melody or so them, and nods simultaneously towards the soft-grained textures of French impressionism and the blunt emotionality of German expressionism; perhaps the two are not so far apart.

Warm-toned in the Haydn, mercurially vivid in the Szymanowski, the players became benign automatons for Stravinsky's Three Pieces, putting a stop on almost all vibrato; these spare slight pieces seemed to deal the clockwork aspect of the Szymanowski to its logical conclusion.

Last came Debussy's Quartet, inevitably a signature work for any French tout ensemble, particularly one and only that shares a name with the work's creators (the original Ysa�e Quartet gave the premiere in 1893). From the impatient opening, through the seamlessly turning cycles of the second move to a finale that seemed a whistlestop retrospective of all that had gone earlier, this was a riveting performance.







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Thursday 7 August 2008

FDA Rejects Schering-Plough's Anaesthetic Drug Sugammadex NDA

�The U.S. FDA has issued a non-approvable letter to Schering-Plough regarding the U.S. firm's New Drug Application (NDA) for sugammadex sodium. The product (likewise marketed under the brand Bridion) is a selective relaxant binding agent that reverses the effects of neuromuscular hinder by rocuronium in general anaesthesia. In a press statement, Schering-Plough has aforesaid that the FDA's concerns over the drug ar related to hypersensitivity or allergic reactions. No issues related to the efficacy of the drug have been mentioned by the agency. Schering-Plough acquired the drug after purchasing biopharmaceutical firm Organon Biosciences in November 2007, and has since touted the experimental product as one of its main gains. Schering has noted that the product is the first base innovation in two decades in the anaesthesia segment, and has committed to working with the FDA to dissolve the issues behind the rejection.


Meanwhile, the company's cholesterol production Vytorin was once once more under the spotlight. The U.S. House Energy and Commerce Committee has asked the FDA to print details of the findings on a study conducted to examine the product's cancer risk, Reuters reports. The field found a higher cancer risk associated with patients taking Vytorin at 39 and with patients on a placebo at 23 in the closely monitored trial.

Outlook and Implications


The rejection will be a setback for Schering-Plough - more in terms of investor confidence in the short term. The company has had a serial of run-ins with regulatory agencies since cholesterol do drugs Vytorin and Zetia (ezetimibe/simvastatin and ezetimibe) were linked to potency adverse safety issues. However, the development is evenhandedly surprising given that an FDA panel gave it a confident go-ahead in March. However, although the committee gave its commendation, it did cite concerns over allergy reactions. Nevertheless, the approval was unanimous. Further, the company gained European Commission approval for marketing the drug in the European Union (EU) as Bridion. For Schering-Plough, the ontogeny will delay the realization of the benefits the U.S. strong obtained when it acquired Organon Biosciences.


From a regulatory linear perspective, the intersection is the fourth in the heel of jilted applications from the FDA that is associated with Big Pharma firms. Notably, the regulative agency had rejected Merck & Co's (U.S.) Cordaptive/Tredaptive (nicotinic acid/laropiprant), Merck and Schering-Plough's respiratory combination dose Claritin and Singulari (loratidine and montelukast), and Eli Lilly's (U.S.) long-acting version of schizophrenic psychosis drug Zyprexa (olanzapine), principally due to safety concerns. The rejection will put the agency's conservative coming to NDAs under the spotlight. Global pharmaceutical major league have already noted that the number of FDA approvals has reduced, triggered by the withdrawal of Merck's Vioxx (rofecoxib) over safety concerns. The office is under increasing pressure from the U.S. authorities, leading to a tightening of criteria for NDA approvals.

http://www.schering-plough.com


View drug information on Claritin RediTabs; Vioxx; Zyprexa.



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