Eli Lilly and Incyte’s second attempt to get U.S. approval of rheumatoid arthritis drug baricitinib could be scuppered again by lingering FDA concerns about safety. A briefing document published ahead of the April 23 advisory committee meeting on baricitinib suggests that Lilly and Incyte’s lightning-fast amendment and refile of the dossier hasn’t added enough data to persuade the FDA to change its stance on the risk of blood clots with the JAK inhibitor.
Digital health appears to be making its way onto the national stage. On Tuesday, FDA Commissioner Scott Gottlieb gave the field a shout-out in his remarks to the US House Subcommittee on Agriculture, Rural Development concerning the Fiscal Year 2019 budget request for the FDA.
On April 6, 2018, the Food and Drug Administration(FDA) approved rucaparib (Rubraca®, Clovis Oncology Inc.), a poly ADP-ribose polymerase (PARP) inhibitor, for the maintenance treatment of recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.
The U.S. Food and Drug Administration (FDA) issued two Complete Response Letters (CRLs) to South Korean manufacturer Celltrion. One was for a proposed biosimilar for Genentech and Biogen’s Rituxan for lymphomas and leukemias, and a proposed biosimilar to AbbVie’s Humira for rheumatoid arthritis, plaque psoriasis, Crohn’s disease and other autoimmune disorders.
Smart inhaler company Adherium announced last week that it has received 510(k) clearance for over-the-counter sales of its inhaler monitoring device for AstraZeneca’s Symbicort aerosol inhaler, called the SmartTouch for Symbicort.
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