This week’s headlines include, fewer drugs approved in 2013 than prior year, Sanofi MS drug doesn’t win approval, cervical cancer genome can lead to treatments, and stem cell news.
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“The number of new drugs approved in the United States fell in 2013 compared with the previous year as fewer applications were filed, though several products for hard-to-treat diseases were approved in record time. The U.S. Food and Drug Administration approved 27 new drugs in 2013, down from a banner year in 2012 which saw 39 drugs approved, the greatest number since 1997 according to FDA data.”
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“Sanofi’s Lemtrada multiple sclerosis treatment has failed to win approval from U.S. regulators, dealing a setback to a drug which was at the heart of the French drugmaker’s $20 billion takeover of biotech firm Genzyme. The U.S. Food & Drug Administration (FDA) rejected Lemtrada for launch in the world’s biggest drug market on the grounds that Genzyme had not shown its benefits outweighed its “serious adverse effects”, Sanofi said on Monday.”
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“The first genome-wide study of cervical cancer mutations in a large cohort of patients was published this week in Nature. The program, undertaken through the Slim Initiative for Genomic Medicine in the Americas (SIGMA) and featuring an international team of researchers from Mexico, the U.S. and Norway, sequenced the whole exomes of over a hundred patients and their cervical tumors in order to identify key mutations involved in this cancer type. “Cervical cancer remains one of the most common deadly cancers around the world, although today vaccination offers the promise of vastly decreasing the number of cervical cancer cases,” said Dr. Matthew Meyerson, a senior co-author of the paper and member of both the Broad Institute and the Dana Farber Cancer Institute, in an email to Bio-IT World. “Finding new genomic alterations in cervical cancer, as we have just reported, offers the promise that new treatments can be tested for patients with life-threatening cervical cancers.”
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“I am a biotech VC, but not a techie. So I don’t follow stem cells, Gene Therapy, and other similar “blockbuster” technologies in the life sciences. Rather than looking at all the gosh-and-golly stuff going into the biotech pipeline, I wait to see what is coming out of the other end. So far, very little in the most innovative areas.”
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“A new stem cell treatment may help heart attack patients do something once thought medically impossible — regenerate dead heart muscle. Scripps Health in La Jolla is one of three centers testing the therapy from Capricor, a Los Angeles biotech company. The cardiac stem cells are meant to boost the heart’s natural ability to perform minor repairs. If it works, scars should shrink and functional heart muscle should grow.”
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“Stem Cell Treatment Owned by Mesoblast Pharmaceutical Set for Launch in Japan,” The Age Business Day
“A treatment owned by Mesoblast Pharmaceutical is set to become the first stem cell treatment to be available in Japan, following an application by its local partner, JCR Pharmaceutical, to launch the product in that market. According to Japanese reports, JCR Pharmaceutical will lodge its application to market a treatment for so-called graft versus host disease (GVHD), which is a side effect of bone marrow or umbilical cord blood transplant surgery, by the end of December.”
If you like this story, please see our blog titled “The Top 15 Cell Culture Dish Ask the Expert Sessions in 2013“