The House is expected to pass the FDA user fee bill and move to conference with the Senate in hopes of completing the legislation before July 4.
With positive Phase II data in hand, Regeneron and Sanofi are planning to begin a Phase III program for REGN727, their PCSK9-targeting antibody for hypercholesterolemia, in June. It would be the first Phase III trial for a PCSK9 inhibitor in lowering LDL cholesterol. The companies released promising data in patients with heterozygous familial hypercholesterolemia on May 26.
At its July 24 meeting FDA’s Oncologic Drugs Advisory Committee will take up GlaxoSmithKline’s supplementary application seeking to treat women who have failed on Roche’s Herceptin (trastuzumab) with its breast cancer drug Tykerb (lapatinib) in combination with Herceptin.