FDA's Onsolis approval restricts distribution; Biogen says Tysabri back on blockbuster track;

> FDA gave the nod to Onsolis, a fentanyl drug for breakthrough pain, under a risk-management plan that restricts distribution to registered prescribers, patients, and pharmacies. FDA release

> With the number of patients on Tysabri growing and new-patient scrips increasing as well, Biogen Idec says the drug is back on track to become a blockbuster. Report

> Cubist Pharmaceuticals swung to a second-quarter profit from a loss one year ago as sales of its antibiotic Cubicin met reduced Street expectations. Report

> Mylan Pharmaceuticals got the FDA nod for its version of the King Pharmaceuticals thyroid deficiency med Cytomel. Mylan release

> Piedmont Pharmaceuticals tapped Michael Kelly as its CFO; previously, he had been CFO of global manufacturing for Novartis Animal Health. Piedmont release

> Boston Scientific won FDA approval for its Taxus Liberte Long stent system. Report

> Bausch & Lomb is moving its global HQ to Madison, New Jersey, creating 70 jobs. Report

> Biogen Idec co-founder Phillip A. Sharp, 65, is retiring from the board of directors. Report

Biotech News

> Researchers say that Medivation's experimental Alzheimer's therapy Dimebon appears to actually increase levels of the toxic protein amyloid beta while still delaying progression of the memory-wasting disease. And they don't quite know what to make of that conclusion. Report

> BIOTECanada just checked the temperature of the country's biotech industry and found that a bad financial fever appears to be getting worse. Report

> Biogen Idec's recent $510 million collaboration deal with Acorda bit deeply into its quarterly profits. Biogen, one of the world's most successful biotech companies, says the deal drove its R&D expenses up 65 percent in the second quarter, driving a 30 percent slide in profits. Report

> An FDA advisory committee has handed Spain's Zeltia a crushing blow, deciding against a combination therapy that includes its lead cancer drug Yondelis (trabectedin) by a vote of 14 to 1. The news cost Zeltia 35 percent of its share price. Report

And Finally... The WHO suspended pandemic H1N1 case counts, saying that the practice is resource-intensive and misdirects disease surveillance. Report

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