Eli Lilly and Company
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Latest From Eli Lilly and Company
Eli Lilly has asked the European Medicines Agency to grant accelerated assessment to its planned EU marketing application for pirtobrutinib. Meanwhile, the agency has rejected requests to fast-track SIFI’s Akantior and Janssen’s Zejula plus Zytiga combination therapy.
While industry concern with FDA’s policy shift on clinical data from China has focused on the disruption in business plans, Republican lawmakers appear to feel that the agency has not gone far enough and are seeking a GAO review of FDA’s entire bioresearch monitoring program.
Concert’s deuterated ruxolitinib analog is potentially third in line to market for alopecia areata, behind Lilly’s Olumiant and a Pfizer JAK3 inhibitor, but may be demonstrating a best-in-class profile.
Xevudy, which was part of the deal, has already seen restrictions on its use due to diminished efficacy against Omicron. Plus, Ocugen is back in the game as the FDA has released the clinical hold on its Phase II/III vaccine trial, while Pfizer/BioNTech release new booster shot data for Comirnaty in children aged 6 months-5 years.
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