Weekly Roundup 5.2.14

I need a bear hug from Friday.

April showers.  We had a lot of them.  Some of them, as you know, were snow showers.  This week, in particular, saw buckets of rain in many areas of the country – sometimes violent buckets – and here in the Mid-Atlantic states, we got our fair share of driving rain which can only mean that we are in for some really, really prolific May flowers.  Looking at my peonies, I am already counting many more buds getting ready to blossom over last year’s somewhat anemic crop.

While there were buckets of rain, there was not a downpour of news out of FDA.  No new warning letters (still only 2 so far this year) and not much press release action of note.  But I’ve looked around at a few other sources and here are a few interesting things from the week.

  • Approval of Zykadia for Late Stage Lung Cancer Drug FDA announced that Novartis had received an accelerated approval for Zykadia (ceritinib), a anapestic lymphoma kinase (ALK) tyrosine kinase inhibitor, for patients with a certain type of late-stage non-small cell lunch cancer (NSCL) which comprises about 85 percent of all lung cancers, though only 207 percent of those patients are ALK-positive.  Zykadia is the fourth drug with breakthrough therapy designation to receive FDA approval and is being approved four months prior to the PDUFA date.  According to the company release, the approval of the drug occurred less than three and a half years after the first patient entered a clinical trial for the compound.
  • White Paper on Pharma Tweetchats – Boehringer Ingelheim published a white paper this week – How Pharma Tweetchats Can Drive Healthcare Innovationwhich covers a variety of topics including helping people understand what a Tweetchat is, how to set one up, and why they are useful particularly for healthcare and pharma.  It is particularly nice that this asset comes by way of a pharma company so that others can learn – peer to peer counseling.

That’s it for me this week folks.  I hope you all have wonderful weekends.

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