Weekly Roundup – 01/23/09

Late posting today – Typepad was curiously uncooperative today.


This week we saw the end of one Administration and the beginning of another, but we also saw more than that.  We saw that America once again stood apart from other nations, doing something no other developed nation to my knowledge has ever accomplished and set a new tone for ourselves and the world.  

On a more micro level, we also saw a great deal of change in the healthcare environment in the U.S., with a new Surgeon General in line, Sanjay Gupta, and heads of HHS, CMS, FDA all going to persons who will be in an "acting" capacity.  

Here is a little bit else of what happened:

  • Interesting List of Hospitals and Social Media - Developed in December, this is a listing of hospitals involved in various social media.   It is interesting to note how much healthcare is gravitating to Social Media, recalling the list of newspapers that are twittering posted a few weeks back in this space.  
  • Grassley Introduces Transparency Bill – Reviving a past effort from the 110th Congress, S. 301- A bill to amend title XI of the Social Security Act to provide for transparency in the relationship between physicians and manufacturers of drugs, devices, biologicals, or medical supplies for which payment is made under Medicare, Medicaid, or SCHIP.
  • FDA Clears First Stem Cell Trial - Geron Corporation(Nasdaq: GERN) announced January 23 that the U.S. Food and Drug Administration (FDA) has granted clearance of the company's Investigational New Drug (IND) application for the clinical trial of GRNOPC1 in patients with acute spinal cord injury.  The clearance enables Geron to move forward with the world's first study of a human embryonic stem cell (hESC)-based therapy in man. Geron plans to initiate a Phase I multi-center trial that is designed to establish the safety of GRNOPC1 in patients with "complete" American Spinal Injury Association (ASIA) grade A subacute thoracic spinal cord injuries.   The company, but not the FDA, issued a release.  
  • Congressional Budget Office Issues Report to Congress on Health IT - CBOhas analyzed the effect on federal direct spending and revenues of the Health Information Technology for Economic and Clinical Health (HITECH) Act.   
  • FDA Issues CRL to SCOLR Pharma's aNDA for CDT(r) 12-Hour Pseudoephedrine –  Scolr Pharmaannounced a CRL issued by FDA issued a CRL for pseudoephedrine – an application that was filed in August 2008 that sought approval for a 120 mg 12-hour tablet.  The company said that the FDA identified the issues as "minor".   

It was a short week, but it sure didn't feel like it.  Hope the weekend lasts long!    

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