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Despite the rejection, analysts saw Regeneron’s use of an alternate filler for Eylea HD as a positive development, with BMO Capital Markets noting that this could signal the end of manufacturing troubles for the franchise.

The approvals come as a pleasant surprise for Regeneron, analysts say, helping bolster the overall product profile of high-dose Eylea despite outstanding manufacturing concerns.

Regeneron’s antibody duos significantly lowered eye itching and redness, as well as pin prick reactivity, in people with cat and birch allergies. Still, BMO Capital Markets expressed uncertainty about the assets’ “commercial potential in a highly generic market.”

The delays, first revealed in Regeneron’s Q2 report, were chalked up to manufacturing issues at Novo Nordisk-owned plants.

As third-quarter earnings continue to roll out, Novartis makes headlines with the second biggest acquisition of the year; Novartis’ CEO also downplayed the impact of Big Pharma pricing deals with the Trump administration; Regeneron continued the trend of dropping cell therapy assets; BioSpace takes a look at how the FDA is functioning mid-shutdown.

Regeneron is aiming to file a regulatory application for DB-OTO by the end of the year.

The discontinued CAR T therapy bbT369 came to Regeneron when the pharma bought all of 2seventy bio’s pipeline assets for $5 million upfront in January 2024.

Delays in the decision dates for high-dose Eylea are linked to issues at a Catalent-owned facility. Once these are resolved, Regeneron expects “to receive favorable action” on these applications, CEO Leonard Schleifer told investors.

Regeneron’s cemdisiran, used alone or in combination with its complement inhibitor Veopoz, significantly improved activities of daily living in patients with generalized myasthenia gravis.