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Investigational Drug Review and Outlook 2011

UBM Canon, April 2011, Pages: 23


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More drugs are being developed for oncology indications by pharmaceutical and biotechnology companies than for any other therapeutic grouping. Of the 100 investigational drugs recognized in this special report, more than one-third target various forms of cancer. One of the potential blockbuster products included in this compilation is Exelixis Inc.’s cabozantinib. As an inhibitor of tumor growth, metastasis and angiogenesis, cabozantinib simultaneously targets two critical kinases involved in the development and progression of many cancers. This drug compound is on track to be submitted for FDA marketing approval during mid-2011.

During 2010, the U.S. Food and Drug Administration received a record 323 orphan-drug designation requests and granted 192 designations, according to published reports. The U.S. regulatory agency approved for marketing 14 orphan products during 2010. Many companies continue to seek additional opportunities to develop more novel therapies for orphan-drug diseases. This report includes details of drugs being developed for various rare diseases including Duchenne muscular dystrophy, the bone-marrow disorder myelofibrosis, and Berger’s disease, a condition that affects the kidney.

In addition to products for rare diseases, some of the investigational drugs in this report have shown first-in-class potential in targeting major disease areas affecting many millions of people. These therapeutic fields include cardiovascular conditions, HIV, diabetes, mental-health disorders, arthritis, osteoporosis, multiple sclerosis, psoriasis, and hepatitis.


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