Pharmaceutical Science Update

Posted By Linda Brown
Found In Microsite: AAPS News Magazine
January 24, 2018 The Massachusetts Institute of Technology’s Broad Institute may have just lost future market dominance in Europe for a potentially highly valuable gene-editing technology known as CRISPR-Cas9. On Jan. 17, the European Patent Office ...
Posted By Linda Brown
Found In Microsite: AAPS News Magazine
On Jan. 17, the Food and Drug Administration (FDA) issued draft guidance  that describes how drugmakers can obtain valuable priority review vouchers allowing faster approval of another product if they develop medical countermeasures (MCMs), defined as ...
Posted By Linda Brown
Found In Microsite: AAPS News Magazine
The project is a move by FDA to provide the public with clinical trial data in a more digestible format, FDA Commissioner Scott Gottlieb said. Under the pilot to begin later in January, nine companies will share some information from their clinical study ...
Posted By Linda Brown
Found In Microsite: AAPS News Magazine
January 24, 2018 The Department of Health and Human Services (HHS) pressed pause on an Obama-era overhaul of regulations governing taxpayer-funded clinical trials and other human subjects research (83 Fed. Reg. 2,885). The latest development comes ...
Posted By Linda Brown
Found In Microsite: AAPS News Magazine
On Jan. 12, the Food and Drug Administration (FDA) approved an expanded use of AstraZeneca's Lynparza (olaparib) to include treating patients with certain types of metastasized breast cancer, whose tumors have an inherited genetic mutation known as BRCA. ...