Susvimo, a PDS version of the blockbuster Lucentis, is a refillable eye implant that will extend Roche's commercial opportunity in wet-AMD but presents training challenges. Pricing is slightly below Lucentis.

Public Company Edition: Xilio, Ventyx, MiNK and Context went public in the US and later traded at or above their initial public offering prices. Also, Sarepta raised $500m and Relay grossed $350m in new offerings, while Oncopeptides, Esperion, Zymergen and Ardelyx reorganized and cut jobs.

A new study highlights a subset of high-cost drugs in Medicaid for which legal and policy tools may be available to manage spending growth.

Practicing obstetricians who are maternal fetal-medicine specialists should make up a ‘significant proportion’ of the advisory committee at the forthcoming hearing, Covis says; CDER calls for a more ‘balanced’ panel that includes expertise in biostatistics, neonatology and epidemiology.