Tag Archives: Rezvoglar

FDA Publishes Slew of CRLs in Effort to Increase Transparency

FDA announced it has published more than 200 CRLs to increase transparency. The CRLs were issued to applications submitted between 2020 and 2024, and all are for drugs that have since gained approval from the agency, a Department of Health and Human Services spokesperson told Fierce Biotech (view article). Below, FENIX provides an overview of select CRLs and brief insight into the FDA openness policy.

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US Insulin Pricing Analysis: Lilly cuts insulin prices by 70% and caps out-of-pocket costs at $35 per month

Lilly announced price reductions of 70% for its most commonly prescribed insulins and an expansion of its Insulin Value Program which caps patients’ out-of-pocket costs at $35 per month or less. Of note, President Joe Biden has already issued a statement stating Lilly’s move is “a big deal, and it’s time for other manufacturers to follow” (view article). Below, FENIX provides highlights and insights into Lilly’s rationale for the price reductions as well as an RAI and basal insulin pricing analysis.

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Medtronic CY Q3 ’22 Earnings Update; Novo Expands Manufacturing Facilities; FDA Approves Lilly’s Rezvoglar as an Interchangeable Biosimilar; Oramed Presents Additional Ph2 PRMD-0801 NASH Data

Four cardio-metabolic related news items have been observed: Medtronic hosted its CY Q3 ’22 earnings call (press release; slides); Novo announced plans to invest DKK 5.4B (~$750M USD) in the expansion of manufacturing facilities in Denmark (view press release); FDA approved Lilly’s Rezvoglar (bs-glargine) as an interchangeable to Sanofi’s Lantus (view label; view article); and Oramed hosted an event to discuss data from its Ph2 trial evaluating 8mg ORMD-0801 compared to placebo in 32 participants with T2DM and NASH (slides; webcast; press release). Below, FENIX provides context and insight on the respective news items.

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