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Re: dDT post# 16542

Saturday, 10/27/2012 10:02:58 AM

Saturday, October 27, 2012 10:02:58 AM

Post# of 53906
November FDA plays

>>> Link back for October plays

11/02/2012 GlaxoSmithKline PLC GSK, GSK.L Raxibacumab injection (BLA)

FDA panel to review raxibacumab injection for treatment of inhalational anthrax.



11/08/2012 Novo Nordisk A/S NVO insulin degludec/insulin aspart and insulin degludec (NDAs)

FDA panel to review two insulins to treat type 1,2 diabetes



11/08/2012 Novartis AG NVS Exjade (deferasirox) sNDA

FDA panel to review Exjade for treatment of chronic iron overload in patients aged 10 years and older with non-transfusion-dependent thalassemia syndromes.

>> FDA Panel cancels date of discussion for the review of Exjade.



11/08/2012 Celgene Corporation CELG Pomalidomide (NDA)

FDA panel to review Pomalidomide for treatment of relapsed and refractory multiple myeloma

>> FDA Panel cancels the date of discussion for the review of Pomalidomide.



11/14/2012 Dynavax Technologies Corp DVAX HEPLISAV (BLA)

FDA panel to review HEPLISAV for hepatitis B virus in adults
-News



11/22/2012 MEDIVATION INC MDVN Enzalutamide (NDA) FDA decision on Enzalutamide for potential treatment of men with castration-resistant prostate cancer

>> FDA approves Enzalutamide to treat men with castration-resistant prostate cancer, on August 31.



11/28/2012 Johnson & Johnson JNJ Bedaquiline (NDA filed by Jannsen Therapeutics, a part of JNJ)

FDA panel to review Bedaquiline for treatment of patients with multi-drug resistant pulmonary tuberculosis.



11/29/2012 THERAVANCE, INC. THRX VIBATIV (telavancin hydrochloride) NDA

FDA panel to review VIBATIV for treatment of nosocomial pneumonia.


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