Look back at pharma news in week to October 5

US Food and Drug Administration approvals dominated much of the news last week. Among these was the FDA’s approval of Regeneron’s Libtayo, marking the firm’s entry into the immuno-oncology sector. The FDA also cleared for marketing: Pfizer’s Vizimpro for a rare form of lung cancer; Paratek’s antibiotic Nuzyra and acne drug Seysara; and Roche’s hemophilia A drug Hemlibra in a much wider patient population, so boding well for the Swiss pharma giant’s moves to expand out of its core oncology franchise that is facing copycat competition. On the deal-making front, there was the unexpected news that Janssen is pulling out of its agreement with Aduro Biotech on cancer drug candidates.

PD-1 approval begins oncology franchise for Regeneron-Sanofi; what comes next?

The FDA approved the jointly developed and commercialized Regeneron and Sanofi PD-1 antibody cemiplimab, now known as Libtayo. Libtayo’s label is consistent with the clinical trial results, and the labelled safety liabilities are consistent with other PD-1 antibodies, says Leerink Research analyst Geoffrey Porges. Libtayo’s list price of $9,100 per 350mg vial, or effectively $12,130 per month, is also consistent with other PD-1 antibodies, and he expects the initial rebating to be modest.