Discovery Labs mounts a new attempt to gain approval on long-delayed Surfaxin; FDA approves Sagent's injectable antipsychotic;

@FierceBiotech: Biomarkers vs. pen-and-paper tests for Alzheimer's: which wins? Story | Follow @FierceBiotech

@JohnCFierce: After a shakeup, iPierian names Nancy E. Stagliano, co-founder of CytomX, as new CEO. | Follow @JohnCFierce

@RyanMFierce: Researchers use neural #stem cells (of iPS variety) to study impacts of potential bipolar-disorder treatments Article | Follow @RyanMFierce

> Discovery Labs says it has responded to the FDA's 2009 CRL on Surfaxin, a long-delayed treatment for respiratory distress syndrome in infants. The biotech says it expects a decision on the drug in six months. Two years ago the FDA questioned certain aspects of a Surfaxin biological activity test (a quality control stability and release test). Discovery Labs has been trying to win an approval for this drug since 2004. Report

> The FDA has approved Sagent's injectable formulation for the antipsychotic drug haloperidol. Story

> Following a management shakeup, iPierian says that it has recruited Nancy Stagliano, the co-founder of CytomX, as its new CEO. iPierian release

> Exelixis reports that the pre-specified number of progression-free survival events required for un-blinding the Phase III data on cabozantinib has been reached. Top-line data is expected early in the fourth quarter of 2011. Release

> Debiopharm and Ascenta Therapeutics struck a licensing deal on AT-406, an early-stage apoptosis molecule. "We are very excited about this collaboration with Ascenta Therapeutics. This company has an impressive scientific team and expertise in the field of apoptosis", said Dr Rolland-Yves Mauvernay, president and founder of Debiopharm. "It should be possible to combine AT-406 (or Debio 1143) with other pro-apoptotic agents, which can potentially bring huge benefits to patients by enhancing the efficiency of the treatment." Release

> Dynavax won a $600,000 SBIR grant to back its research on the role of the phosphoinositide 3-kinase in preclinical models of skin autoimmune inflammation. Dynavax release

Pharma News

@FiercePharma: Quirky Medicaid rules gave generics firms a loophole to hike prices on capsules, but not tablets, whistleblower says Report | Follow @FiercePharma

> Par used Medicaid rule to overcharge for meds, suit says. Article

> Longtime liberal advocate to lead generics industry group. More

Medical Device News

> St. Jude gets CE Mark for migraine device. News

> GI Dynamics starts trading on ASX. Report

> Veracyte thyroid test could reduce unnecessary procedures. More

> Urologix signs deal to sell Prostiva RF therapy system for BPH. Item

Drug Delivery News

> Virus sent on seek-and-destroy mission against cancer. Article

> Needle-free delivery market to double in 5 years, analyst says. Story

> Probiotics researcher says he's found a better delivery polymer. Article

> BDSI moves forward with anti-opioid drug, delivery method. Report

> Molecular motor could--someday--power drug delivery device. Piece

> Making sure your nanoparticles are pure. More

And Finally... UN officials say there's no reason to hit the panic button yet on a new mutant strain of bird flu that has popped up in Asia. There is no evidence, they say, that this new strain is any deadlier than the original version. Story

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