Officials of the U.S. Food and Drug Administration and Alnylam Pharmaceuticals have agreed on safety measures and a “risk mitigation strategy” to allow the resumption of clinical studies of fitusiran, the company said in a recent press release. All ongoing trials of fitusiran had been suspended after the Sept. 7 death…
The European Medicines Agency has recommended marketing authorization for Shire’s Adynovi (BAX-855) as a treatment for adults and adolescents with hemophilia A. Approval would mean the therapy could be used twice a week to prevent bleeding episodes and to counter bleeding when episodes do occur. The U.S. Food and Drug Administration…
Interim results from the Phase 3 ASPIRE study indicate that patients with hemophilia A showed continuous improvement in joint health for nearly three years while receiving prophylactic dosing of Bioverativ and Sobi’s Eloctate. The interim results were reported in a study titled, “Improved joint health in subjects with severe haemophilia A…
The U.S. Food and Drug Administration (FDA) has accepted Bayer’s Biologics License Application (BLA) filing for BAY94-9027 to treat hemophilia A in adolescents starting at age 12, and in adults. A BLA is a marketing application that covers biological products, as opposed to chemically synthesized ones, and its…
Researchers at South Dakota State University (SDSU) studying mouse sperm found that drugs such as those used to treat HIV infection suppress L1s, or snippets of DNA that cause gene mutations. L1s are called transposons or mobile genetic elements. They are DNA fragments in the genome that replicate themselves and…
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