- comments again on the two cases of PML that were reported in July and the need to affirm to those taking Tysabri that the risk of PML exists for use in monotherapy.
- Prescribing information for Tysabri will be revised to include information informing prescribers and patients that cases of PML have occurred in patients taking Tysabri as monotherapy. Healthcare professionals should continue to monitor patients for sign and symptoms of PML. Additionally, Tysabri should not be infused if PML is suspected.
- FDA states that while the two patients who developed PML were on monotherapy, the FDA still believes that Tysabri monotherapy may confer a lower risk of PML than when Tysabri is used together with other immunomodulatory medications.

Other headlines for [ELN]

• ELN 11/18/2008 02:08pm
  Elan Corp PLC CEO: Sees 20% market share as achievable over time for Tysarbri, expects to complete pipeline transaction by mid 2009 with Oncology or other drugs- Notes could continue cost cutting measures through more...
  
• ELN 11/10/2008 01:18pm
  Elan Corp PLC Signs agreement with Azur Pharma to Develop a Once-Daily Clozapine- Clozapine is currently marketed in immediate release presentations, including Azur's proprietary orally disintegrating tablet more...
  
• JNJ 11/1/2008 06:03pm
  Johnson & Johnson Inc Study suggests treatment with Paliperidone ER improves symptoms of schizoaffective disorder-Patients with schizoaffective disorder receiving paliperidone extended release tablets (paliperidone ER) more...
  
• BIIB 10/29/2008 04:29pm
  Biogen Idec, Inc. Notified of case of PML in one MS patient taking Tsyabri - filing- the patient had gotten 14 doses of Tysabri before being diagnosed with the brain illness PML
  
• ELN 10/24/2008 09:58am
  Elan Corp PLC Caris & Company Raised ELN to Average from Sell (timing uncertain)- likely pre-open
  

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