Archive: October, 2009

• Biogen’s Tysabri Problems the Fault of European Docs?

  As mentioned in my last BNET Pharma posting, Biogen Idec’s key multiple sclerosis drug Tysabri had been linked to 23 worldwide cases of a potentially deadly brain [...]

  • Caroline says: 23 cases of PML have been confirmed in patients taking Tysabri, most of them in European countries and with an alarmingly high presence in Germany. The US has the fewest cases, and the most stringent patient monitoring program. Is this the reason there are more cases of PML in countries that aren't so strict?
     
  
  

  • FDA delays ruling on Acorda’s MS drug until 1/2010

    October 22, 2009 6:38 AM ET HAWTHORNE, N.Y. (AP) – Acorda Therapeutics Inc. said Thursday the Food and Drug Administration delayed a ruling on its multiple sclerosis [...]

    • Caroline says: The FDA has delayed their ruling on fampridine-sr, the walking drug from Acorda. The ruling was supposed to be made Oct 22, but Acorda has submitted some new risk-evaluation data so the decision is delayed.
       
    
    

    • Newly Published Data Show Copaxone Promoted Remyelination of Damaged Axons

      The purpose of this study was to examine the effect of glatiramer acetate on oligodendrogenesis (the formation of myelin-producing glial cells in the central nervous system) and [...]

      
      

      • Teva Sues Mylan Over MS Drug Copaxone

        Teva Pharmaceutical Industries Ltd. issued a press release last week discussing the abbreviated new drug application (ANDA) containing a Paragraph IV certification for COPAXONE® (glatiramer acetate injection), [...]

        • Caroline says: Not long ago, I posted a similar article about Biogen blocking the generic equivalent of Avonex and now it appears Teva is doing the same thing with Copaxone. The company is saying that Copaxone is so complex that only they can develop it...I'm not kidding. Read the article. This is the logic behind their litigation. Once again we see pharma putting profits over patients...shame on you, Teva.
           
        
        

        • A New Cause for MS?

          By Henry L. Davis NEWS MEDICAL REPORTER October 15, 2009, 6:36 AM Buffalo physicians announced Wednesday that they have started a large study that could overturn thinking [...]

          • Caroline says: This is science that is totally out of my realm of understanding (or coherently commenting on)...so, the MS Society's response will have to suffice: "There is insufficient evidence to suggest that this phenomenon is the cause of MS." Nuff said, I suppose. Read it and decide for yourself.
             
          • Related Links:
          • http://www.buffalonews.com/cityregion/buffaloerie/story/828345.html?imw=Y…
          
          

          • What’s the Point of Extavia?

            Featured Story Oct. 16, 2009 By Angela Maas, Managing Editor Another drug in the self-injected multiple sclerosis (MS) class recently came onto the marketplace. But many within [...]

            • Caroline says: The general consensus on Extavia (the generic form of Betaseron that received FDA approval earlier this year) is that its sole purpose is to create Novartis' entree into the MS marketplace in preparation for FTY-720. The MS market is one in which until now, Novartis has been totally unfamiliar. The strategy is clear -- but the point of Extavia is not, according to this very interesting article. Several experts note that Betaseron has the lowest market share of all interferons, and although the price of Extavia hasn't been officially released, insiders report it will cost barely less than Betaseron. The only thing in this article that I patently disagree with is that Copaxone is the most prescribed interferon...um, since when? Interesting insight into pharma marketing strategy and a fun read, nonetheless!
               
            
            

            • Acorda Announces Positive Vote by FDA Advisory Committee for Fampridine-SR

              Wed, Oct 14, 2009 * Committee Views Fampridine-SR as Safe, Effective and Clinically Meaningful for Improving Walking in People with Multiple Sclerosis * Conference Call Scheduled for [...]

              • Caroline says: Acorda had a special advisory board meeting requested by the FDA to discuss side effect issues in doses above 10mg. The outcome was positive for Acorda: in 10mg doses the drug appears safe and it helps people walk.
                 
              
              

              • Luteolin as a therapeutic option for MS

                Multiple sclerosis (MS) remains without an effective treatment in spite of intense research efforts. Interferon-beta (IFN-beta) reduces duration and severity of symptoms in many relapsing-remitting MS patients, [...]

                • Caroline says: It is refreshing to see a potential MS treatment that naturally occurs in food. Not that drugs don't help, of course. But they're drugs, and it's not great to be on a lot of them at once. To my knowledge, studies on luteolin have not been undertaken on PWMS. But, it is abundant in foods like parsley, artichoke, basil, and celery.
                   
                
                

                • Avanir posts mixed late stage Zenvia study results

                  ALISO VIEJO, Calif. — Avanir Pharmaceuticals Inc. on Friday reported mixed results for its drug candidate Zenvia, which is intended to reduce involuntary emotional outbursts in patients [...]

                  • Caroline says: This drug is being studied in other neurological disorders in addition to MS. There are no currently approved treatments for pseudobulbar effect (uncontrolled crying or laughing) for any neurological condition.
                     
                  
                  

                  • MS Walking Improvement Drug Receives Negative FDA Review

                    By MATTHEW PERRONE (AP) – 2 days ago WASHINGTON — Shares of Acorda Therapeutics plummeted Friday after the Food and Drug Administration issued a negative opinion that [...]

                    • Caroline says: I think a lot of people were excited about this drug...it had a huge amount of press so this is a bummer for many people. The risk of seizure is an issue with doses above 10mg. This means that the drug can still be approved by the FDA, but it may have a "black box" warning about seizures. The FDA will complete its review Oct 22, 2009.
                       
                    
                    
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