Amgen catches a break as FDA rejects Neulasta knockoff; Zafgen gets a new CEO as Hughes moves to top science job
→ Amgen caught a break today on its blockbuster franchise drug Neulasta. The FDA has rejected an application from Biocon and Mylan for a knockoff of the biologic after citing manufacturing issues at the Indian company that need to be resolved. Novartis was recently handed a CRL for its biosimilar of Neulasta as well, conserving a multibillion-dollar market for Amgen. Biocon, though, says it doesn’t expect a delay in its commercial launch plans.
→ Jeff Hatfield is being given the leading role at Zafgen, which is making a comeback bid after its lead drug proved unsafe. Hatfield, coming off his role as CEO of Vitae, which was sold to Allergan, will take the helm as Tom Hughes moves into a new role as chief scientific officer. Hughes is also retaining the president’s title in the shift at Zafgen. Hughes says he’s happy with the change-up, noting: “We are ramping up our clinical activities with ZGN-1061 now in Phase 2, and have two preclinical candidates that are advancing toward the clinic. We also have exciting new insights into the MetAP2 pathway that warrant an increased commitment to advance our understanding of its therapeutic potential and develop new drugs leveraging its impact.”
→ Ex-JPMorgan exec and newly minted venture exec Stephen Berenson is joining the board at Moderna, where Flagship chief Noubar Afeyan is chairman of the board. Berenson joined Flagship as an executive partner last summer after wrapping a stint as vice chairman of investment banking.
→ Celgene’s slow and steady entry into neurodegeneration R&D is progressing nicely. After the “successful” completion of a screening program, Evotec is picking up a $5 million milestone for its neurodegeneration work for Celgene.