HHS Eyed Optimal Use Of Protease Inhibitors Even Before Victrelis Approval
Even before FDA’s May 13 approval of Merck’s protease inhibitor Victrelis (boceprevir) for hepatitis C, federal health officials were eyeing the best way to maximize treatment with this new class of drugs.
You may also be interested in...
A series of federal public health initiatives are aligning to expand the market for the first two protease inhibitors expected to win approval for hepatitis C treatment.
Agency is working with manufacturers, including Takeda and Emergent BioSolutions, to accelerate development of hyperimmune globulin products, with an eye toward starting clinical testing in several months; new FDA guidelines on convalescent plasma collection for single-patient emergency IND use are helpful in understanding agency expectations around source plasma collection for manufactured products as well, Emergent SVP Laura Saward says.
Sanofi’s Lantus stands alone as the only insulin product still listed in the ‘Orange Book’ post-transition because it is referenced in Mylan/Biocon’s pending 505(b)(2) application for insulin glargine; the FDA said it stands ready to review biosimilar and interchangeable applications that reference the newly ‘deemed’ biologic products.