Cadence wins FDA nod for Ofirmev; FDA staff backs Gardasil for anal cancer;

@FiercePharma: Pharma wants selective tweaks to healthcare reform. Article | Follow @FiercePharma

> Cadence Pharmaceuticals won the FDA's nod for its injectable pain and fever relief drug, Ofirmev. Report

> Merck's Gardasil vaccine should win expanded approval to prevent anal cancer and precancerous lesions in men and women, according to an FDA staff review. Story

> NuPathe has filed an NDA for transdermal delivery of migraine meds. Report

> Neurological disorder specialist Lundbeck has posted a modest growth in revenue for the third quarter, but warned the looming patent expiry for Lexapro would soon cut into its figures. Item

> Medco Health Solutions projected earnings would rise as much as 17 percent next year despite challenges and painted a rosy picture for the next decade, sending shares up more than 10 percent. Medco release | Article

> Roche's Tamiflu relieves flu symptoms more effectively than a combination of it and GlaxoSmithKline's Relenzaand should be the first choice for flu patients, scientists say. Report

> Lonza said its contract manufacturing business seems to be enjoying a return to form in the third quarter, despite continued volatility due to more stringent oversight of the drug approval process by regulatory authorities. News

> Nektar Therapeutics says it has entered into a non-exclusive agreement to manufacture and supply proprietary polymer material to Amgen. Report

> Measuring three biomarkers from a single blood sample may help doctors identify patients who are at high risk of developing chronic kidney disease, according to data from a 2,345-patient study published in the Journal of the American Society of Nephrology. Report

> Nanoshells--hollow silica spheres covered with gold--were invented and are being tested in Houston. And they continue to surprise researchers with how effective they are. Researchers say they are killing breast cancer cells at a previously unreachable root level. Article

> No, HIFU is not a three-line poem. It's an acronym for High Intensity Focused Ultrasound, and the French ultrasound company EDAP TMS has announced that after three years of testing, it has proven that HIFU can direct ultrasound-sensitive liposomes to deliver cancer drugs. News

Biotech News

 @FierceBiotech: The Top Writers in Biotech. Report  | Follow @FierceBiotech

 @JohnCFierce: The FDA embarks on long journey toward biosimilar rules. Article  | Follow @JohnCFierce

> FDA delays decision on BMS cancer drug ipilimumab. News 

> Idenix taps Renaud as CEO. Story 

> Karyopharm lands $20M in Series A. Item 

> Following FDA rejection, NicOx cuts 30 jobs. News 

Drug Delivery News

> HepaLife launches subsidiary for transdermal drug delivery. Story 

> NuPathe files NDA for transdermal delivery of migraine meds. News 

> Focused ultrasound releases cancer drug. Report 

> Nanoshells surprise scientists by destroying cancer stem cells. Story 

> Biodegradable nanoparticles from Canada show potential. Article 

> Diagnosis and treatment of lung injury using quantum dots. News

Medical Device News

> Wake Forest regenerates sustainable mini-livers. Report 

> Endologix buys Nellix in potential $54M deal. Article 

> FDA classifies Medtronic tissue stabilizer recall as Class I. Story 

> Intersect raises $30M for sinus treatment. Article 

> New Zealand device companies, research work shine. Item

> GE buys Orbotech unit. Report

> Stryker buys Boston Sci unit, Porex Surgical. News 

> PerkinElmer, LinaTech enter agreement. Item

And Finally... A prominent French physician was busted yesterday on charges that he helped a hedge fund avoid a $30 million bloodbath by leaking inside information about a drug trial. Report

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