PharmaMar Recibe el Ok de la FDA Para Iniciar Fase I con PM54 en Combi con Inmuno Para Posible Tratamiento . PARA EI RELEVO DE LURBINECTEDIN ESTABAN PM184 Y PM14 AMBOS RETIRADOS POR LA CIA. AHORA HAY OTROS DOS FÁRMACOS EN FASE I EN EL INTENTO DE RELEVAR A LURBINECTEDIN : PM54 Y PM534 ... EL PROBLEMA ES QUE AMBOS AÚN ESTAN EN FASE I CON TODO LO QUE ESTO IMPLICA EN CUESTIÓN DE PLAZOS ... YA QUE PARA REALUZAR 3 FASES CLÍNICAS HACEN FALTA DE 12 A 15 AÑOS ... NOS IRÍAMOS AL 2040.
10 octubre 2012
Lurbinectedin ( PharmaMar ) . New Animal Models can Revolutionize the Study of Cancer .
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Doxil , J&J Ya ha Pedido a la FDA y a la EMEA una Aprobación para Fabricar de Nuevo el Farmaco .
... Now, J&J wants to enlist Ben Venue's help again. As The Wall Street Journal reports, J&J's new Doxil plan would rely on Ben Venue to produce the drug, in areas of its Bedford plant that are now available and approved for use. Another supplier would handle sterile filtration and aseptic filling, to make sure the drug isn't contaminated.
J&J has asked FDA and its counterparts in the EU to approve the new process, the WSJ says. That would amp up Doxil supplies in the short term, giving J&J time to find a long-term manufacturer for Doxil.
J&J has asked FDA and its counterparts in the EU to approve the new process, the WSJ says. That would amp up Doxil supplies in the short term, giving J&J time to find a long-term manufacturer for Doxil.
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