Mylan N.V. and Biocon Ltd. said the FDA has accepted Mylan's Biologics License Application for MYL-1401H, a proposed biosimilar to Neulasta (pegfilgrastim), for filing through the 351(k) pathway.
MIODx said it has signed an exclusive license for two key immunotherapy technologies from the University of California, San Francisco.
The new Cleveland Clinic Taussig Cancer Center will begin welcoming patients March 6.
Jeffrey Patrick was named director of the Drug Development Institute at The Ohio State University Comprehensive Cancer Center–Arthur G. James Cancer Hospital and Richard J. Solove Research Institute.
Moonshot appropriations are not a substitute for sustained increases in appropriations, NCI Acting Director Doug Lowy said at the meeting of the National Cancer Advisory Board Feb. 15.
Marcia Crosse: This “failure of the adverse event reporting system” should serve as a “wake up call”
Hundreds of women were injured or have died from upstaging of unsuspected uterine cancer by power morcellation because FDA didn’t know the actual risk of cancer in fibroids, and hospitals failed to report harm, according to the U.S. Government Accountability Office.Between 1991 and 2014, FDA cleared 25 submissions for power morcellators to be marketed in the U.S. The GAO report notes that FDA had been aware of the device's potential for spreading tissue since 1991.
FDA's passive reliance on self-reporting by hospitals and device manufacturers allowed harm caused by power morcellators to go unnoticed for over two decades—likely contributing to injury and deaths of hundreds of women, according to the U.S. Government Accountability Office said.
It took the Multiple Myeloma Research Foundation nearly a decade and over $40 million to create what the foundation describes as the largest disease-specific cancer genome dataset in existence.
The data on the second most common blood cancer—with genomic information from about 1,400 patients—was compiled by the Multiple Myeloma Research Foundation through a genome mapping initiative and a $40 million network of clinical trials.
The Government Accountability Office Feb. 8 released an analysis of FDA's failure to detect the health hazards of power morcellation, a once widely used procedure that has been shown to upstage uterine cancers.
