Archive: July, 2010

• FDA Grants Cladribine Priority Review

  July 28 (Bloomberg) — Merck KGaA said U.S. regulators granted the cladribine multiple sclerosis pill priority review, reducing to six months from 10 the time it will [...]

  • Caroline says: The FDA has granted priority review status to Merck's oral MS pill, cladribine. Priority review status reduces FDA review time from 10 months to 6...thus putting a Q4 2010 approval date possible for the second MS oral to be FDA approved this year (Novartis' Gilenia will likely receive approval in September 2010). This FDA priority review status comes on the heels of Russia's approval of cladribine earlier this month. Big news, folks.
     
  • Related Links:
  • http://www.businessweek.com/news/2010-07-28/merck-kgaa-says-fda-grants-cladribin…
  
  

  • If caught early, Tysabri-PML not fatal for MS patients

    Alexandra Schroder, M.D., the lead investigator from Ruhr-University in Bochum, Germany points out that this is different for those who don’t have multiple sclerosis (MS) and get [...]

    • Caroline says: This is good news for Tysabri patients -- the previously always fatal PML side effect can now be controlled if caught early. ALL patients on Tysabri in the US must be monitored in the TOUCH prescribing program -- so PML is likely caught earlier.
       
    • Related Links:
    • http://www.examiner.com/x-32750-Lima-Multiple-Sclerosis-Examiner~y2010m7d22-If-c…
    
    

    • EX-US: First Oral Approved for PWMS: Cladribine approved in RUSSIA

      Merck Serono, a division of Merck KGaA, Darmstadt, Germany, announced today that the Russian Federal Service on Surveillance in Healthcare and Social Development has become the first [...]

      • Caroline says: The Russian approval of Merck's cladribine marks approval of the FIRST oral MS drug in the world. The Russian Federal Service on Surveillance in Healthcare and Social Development (Russia's FDA) has approved Cladribine for RRMS. It will be marketed under the brand name Movectro and Russian launch is expected in early 2011.
         
      • Related Links:
      • http://www.prnewswire.co.uk/cgi/news/release?id=291909…
      
      

      • Genmab reports positive interim results from Phase II MS trial

        Jul 07, 2010 (Datamonitor via COMTEX) – Genmab, a biotechnology company, has announced positive interim results from an ofatumumab Phase II safety and pharmacokinetics study in patients [...]

        • Caroline says: Ofatumumab is currently approved for people with CLL (chronic lymphocytic leukemia) and is being studied for some autoimmune disorders and other forms of cancer (b-cell). It is a human monoclonal antibody (anyone notice a trend here?)...being studied by Genmab for RRMS.
           
        • Related Links:
        • http://www.tradingmarkets.com/news/stock-alert/gnmbf_genmab-reports-positive-int…
        
        

        • Is There a Link Between Depression and MS?

          Multiple sclerosis (MS) is a disease that steadily erodes the ability for nerve cells to communicate and this leads to all kinds of neurological symptoms, often slowly [...]

          • Caroline says: I don't really like this article for the generalizations it makes. However, I do think it is important to address depression and MS, since it is a pretty ubiquitous issue. This study found that the hippocampus (the part of your brain responsible for long-term memory) in PWMS is smaller than in those without MS.
             
          • Related Links:
          • http://www.scientificamerican.com/podcast/episode.cfm?id=the-connection-between-…
          
          

          • Progressive forms of MS may have new and viable treatment options

            Dr. Saud A Sadiq, of the Multiple Sclerosis Research Center of New York (MSRCNY), has this to say about their new findings, “We have opened an avenue [...]

            • Caroline says: So great to hear that there are emerging options for progressive forms of MS. Currently, Betaseron and mitoxantrone are the only approved disease-modifying treatments for secondary progressive MS (compared with none for primary progressive MS)...and the need is very clearly there for more. These results are hopeful news!
               
            • Related Links:
            • http://www.examiner.com/x-32750-Lima-Multiple-Sclerosis-Examiner~y2010m7d1-Progr…
            
            

            • University of Buffalo to Conduct CCSVI Trial

              BUFFALO, N.Y. — Buffalo medical researchers led by a team from the University at Buffalo Department of Neurosurgery, will embark on a landmark prospective randomized double-blinded study [...]

              • Related Links:
              • http://www.buffalo.edu/news/11500…