Lilly Unlucky? Lilly Leads Big Pharma In US FDA Complete Response Letters
Executive Summary
Clinical concerns outweigh quality issues in big pharma CRLs, a Pink Sheet analysis finds, making mirikizumab – the fourth new product candidate sponsored by Lilly to receive a CRL since 2021 – even more of an outlier: it was turned back by FDA because of manufacturing concerns.
You may also be interested in...
Lilly Plans Mirikizumab Filing For Crohn’s After Phase III Success
Mirikizumab, already under review at the FDA for ulcerative colitis, bests placebo on two primary endpoints in Crohn’s. Lilly hopes to beat AbbVie’s Skyrizi, already approved for Crohn's, to market in UC.
EU Decision Time For Janssen’s Talquetamab & 14 Other Products, But MSD Withdraws Lagevrio Filing
A bumper crop of products are up for an opinion this week by the European Medicines Agency’s human medicines committee, the CHMP, as to whether they should be approved in the EU.
EU Crunch Time For Previously Rejected Lagevrio & Other New Drugs
MSD/Ridgeback Biotherapeutics’ COVID-19 treatment Lagevrio is among the products that are up for an opinion this week from the European Medicines Agency on whether they should be recommended for use across the EU.