FDA Approves Investigational MS Trial

New Drug Approvals

The stem cell research division of the Tisch MS Research Center of New York announced that the U.S. Food and Drug Administration (FDA) approved autologous, mesenchymal stem cell-derived neural progenitor cells (MSC-NPs) as an Investigational New Drug (IND) for an open label, phase 1 clinical trial in the treatment of multiple sclerosis.



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Personalized Tumor Vaccine Hits Phase 2

New Drug Approvals



str ref———-http://www.kidneycancerinstitute.com/Bevacizumab.html

Northwestern Medicine recently joined a landmark clinical trial to investigate if a vaccine made from a patient’s own brain tumor is effective in slowing tumor progression and extending survival. The randomized phase 2 trial will study how well giving the study vaccine with or without Avastin (bevacizumab) works in treating patients with recurrent glioblastoma multiforme (GBM).



(Avastin, Genentech Inc.- Year approved:2009)
Avastin (or bevacizumab to the scientific community) is a humanised monoclonal antibody that is directed against all biologically active forms of VEGF. Antibodies are molecules that are typically a normal part of the human immune system. An antibody is meant to bind to a very specific target which is then typically destroyed and removed by the body. Avastin is an antibody that binds VEGF and acts to block its action.
Bevacizumab was one of the first antiangiogenic agents to demonstrate activity against…

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Alnylam Hemophilia Drug Garners Orphan Drug Status

New Drug Approvals

CAMBRIDGE, Mass., Aug 14, 2013 (AP) — The Food and Drug Administration has granted an “orphan drug designation” to a potential hemophilia treatment from Alnylam Pharmaceuticals Inc.

Orphan drug status is awarded to drugs that could treat diseases that affect fewer than 200,000 people in the United States. It comes with some added marketing exclusivity.

The Cambridge, Mass., company said Wednesday that the agency gave the designation to a drug labeled ALN-AT3 for the treatment of hemophilia B. Alnylam has tested the drug in mice and plans to start studies involving humans early next year.

for the treatment of hemophilia B. Alnylam has tested the drug in mice and plans to start studies involving humans early next year.



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Propecia Could Save 70,000 Men From Prostate Cancer

New Drug Approvals



The baldness drug propecia could help reduce the risk of prostate cancer with less side-effects than previously thought, according to a new study.

By Amir Khan, Everyday Health Staff Writer

Warding off prostate cancer may be as easy as growing your hair, according to new data published in the New England Journal of Medicine by researchers from the University of Texas Health Science Center at San Antonio. The researchers followed up on patients from one of their previous studies, and found that the baldness drug finasteride, also known as Propecia, reduced the risk of prostate cancer by more than a third, and resulted in less-severe side effects than previously thought.

“If you look at the number of prostate cancers that are diagnosed annually and multiply that by 30 percent, that’s the number of cancers we might be able to prevent each year,” Ian Thompson Jr., MD, study author and director…

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