Drug and Health News

Here you will find a quick summary of key items from the mass media and links to their sources.  

12/06/2007 - TV Show "Mystery Diagnosis" Spotlights PNH

08/27/2007 - FDA Assigns Fast Track Status to Pharmion's Oral Azacitidine (Vidaza®) for MDS

06/21/2007 - European Commission Approves Soliris for Treatment of Paroxysmal Nocturnal Hemoglobinuria

05/21/2007 - Revised Warnings and Adverse Reactions for Exjade (deferasirox)

03/19/2007 - FDA approves eculizumab (Soliris®) to treat Paroxysmal Nocturnal Hemoglobinuria (PNH)

11/14/2006 - FDA Grants Priority Review for Soliris (eculizumab) Biologics License Application for Treatment of PNH

10/05/2006 - Drug Study Results Offer Hope for Bone Marrow Disease Patients

09/21/2006 - Study Offers Hope For Rare Bone Marrow Disease

08/30/2006 - Exjade approved for the European Union

06/13/2006 - Vidaza NDA Supplement for IV Administration Accepted by FDA

06/12/2006 - Results of MDS studies presented at 2006 ASCO meeting

06/02/2006 - Dacogen (decitabine) for injection is now commercially available

05/03/2006 - Dacogen (decitabine) approved by the FDA for patients with all subtypes of myelodysplastic syndromes (MDS)

05/02/2006 - Dacogen trial results published in Cancer

04/25/2006 - Results from phase III study of deferasirox published in Blood journal

04/24/2006 - Major national non-profits partner with Losta Helping Hands

04/03/2006 - Generic equivalent of iron overload drug Desferal receives FDA approval

03/30/2006 - IV infusion approval sought for Vidaza

03/14/2006 - Dacogen trial results released

03/10/2006 - FDA Blood Products Advisory Committee (BRAC) makes recommendation on platelet donation guidelines

03/10/2006 - FDA Pediatric Oncology Subcommittee to discuss Exjade

03/03/2006 - FDA Blood Products Advisory Committee (BPAC) to discuss proposed changes to guidance document on platelet donation

01/26/2006 - Alexion Reports Phase III results for eculizumab

12/28/2005 - Revlimid® (lenolidomide) approved by the FDA for patients with a subgroup of myelodysplastic syndromes (MDS)

12/12/2005 - American Society of Hematology meets in Atlanta

12/06/2005 - ASCO recognizes Revlimid as one of top 11 advances for cancer treatment in 2005

11/03/2005 - Once-daily oral iron chelator Exjade(R) receives approval in the U.S.

11/01/2005 - President George W. Bush outlines plan to fight flu

10/26/2005 - REVLIMID(R) Marketing Authorization Application Accepted by European Medicines Agency for Review

10/21/2005 - Bone Marrow Failure Symposium meets in Washington DC

10/11/2005 - MDS Presentations in 4 U.S. Cities

10/03/2005 - FDA extends review date for Revlimid

09/30/2005 - FDA Blood Products Advisory Committee (BPAC) recommends Exjade® be approved

09/14/2005 - FDA Oncologic Drugs Advisory Committee (ODAC) recommends REVLIMID(R) for full approval

09/13/2005 - MGI Pharma and SuperGen received approvable letter from the FDA for Dacogen(TM) requesting submission of phase III clinical trial data

09/01/2005 - MGI Pharma and SuperGen receive approvable letter from the FDA for Dacogen(TM) requesting submission of phase III clinical data

07/06/2005 - Phase II clinical trial data for Aranesp ® presented at the 17th International Symposium of the Multinational Association of Supportive Care in Cancer (MASCC) in Geneva

06/22/2005 - FDA grants priority review for Exjade® (deferasirox)

06/21/2005 - FDA grants priority review for Celgene’s REVLIMID®

06/07/2005 - Celgene's REVLIMID® (lenalidomide) New Drug Application accepted for review by FDA

06/05/2005 - Novartis Oncology presents clinical trial data for Exjade® (ICL670) at the European Hematology Association meeting

05/31/2005 - Medical school standards for clinical trial agreements with drug companies

05/25/2005 - Genetic testing in MDS

05/18/2005 - Results of MDS studies presented at ASCO meeting

05/03/2005 - Novartis files Exjade® New Drug Applicationwith FDA

04/08/2005 - REVLIMID® New Drug Application submitted to FDA for review

02/10/2005 - Results of REVLIMID® study published in New England Journal of Medicine

01/04/2005 - Dacogen NDA accepted for filing by FDA

12/05/2004 - American Society of Hematology meets in San Diego

11/01/2004 - Dacogen New Drug Application (NDA) submitted to FDA

11/01/2004 - Eculizumab clinical trial begins for PNH Patients

10/25/2004 - Dacogen™ (decitabine) accepted for review by European Medicines Agency (EMEA)

07/20/2004 - Alexion reaches agreement with FDA for phase III study of eculizumab

07/02/2004 - Bone marrow transplant guidelines for MDS

06/16/2004 - Preliminary data on Trisenox® shows response in MDS

06/02/2004 - Memory and concentration study for MDS patients

05/19/2004 - FDA approves Pharmion's Vidaza™ for the treatment of MDS

04/20/2004 - Alexion presents one year cumulative results of ongoing trial in PNH

04/01/2004 - Results from Dacogen™ (decitabine) phase III study

03/03/2004 - REVLIMID® receives orphan drug designation from European Commission for MDS

02/23/2004 - FDA accepts Pharmion's New Drug Application for Vidaza™

02/05/2004 - Effect of Eculizumab in Patients with PNH

12/30/2003 - Pharmion Submits New Drug Application for Vidaza™ (azacytidine)

12/22/2003 - Novacea Stops Enrollment in DN-101 Trial For MDS

12/08/2003 - Eculizumab Granted Orphan Drug Status for Treatment of PNH

11/19/2003 - American Society of Hematology Meets in December

11/19/2003 - Telik Announces Results from Phase 1-2a Trial of TELINTRA™ for MDS

11/06/2003 - Cleveland Clinic Taussig Cancer Center Receives $4.5 Million Grant to Establish Bone Marrow Failure Clinical Research Center

05/19/2003 - Recent Studies on Two Oral Iron Chelators - ICL-670 in the U.S. and Deferiprone in Italy

05/19/2003 - TRISENOX® Produces High Rates of Response in MDS

05/19/2003 - REVIMID® Clinical Data Shows Promise for MDS

04/15/2003 - REVIMID® Receives Fast-Track Status from FDA

03/17/2003 - Patient Enrollment Completed in Phase III Clinical Study of Decitabine

03/13/2003 - Counterfeit PROCRIT® Alert

02/27/2003 - Decitabine Granted Orphan Drug Status in Europe