XTalks
OCTOBER 22, 2021
In July 2021, the agency approved the first interchangeable biosimilar product, Semglee (insulin glargine-yfgn) for the treatment of diabetes. Semglee is both biosimilar to, and interchangeable with, Lantus (insulin glargine). Biosimilars are sometimes mistakenly likened to generics, but the two are not the same.
Drug Discovery World
FEBRUARY 23, 2024
In a breakthrough for advanced therapies, this week saw the FDA approve the first ever cell therapy for solid tumour cancers, but there were other significant developments in the cell and gene therapy space.
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XTalks
JUNE 5, 2023
GLP-1 stimulates insulin production, thus reducing blood glucose levels, and it interacts with the brain to suppress appetite and create a feeling of fullness. As of May 2023, both Ozempic and Wegovy were on the FDA’s Drug Shortages list due to a global shortage of semaglutide.
pharmaphorum
NOVEMBER 21, 2022
The company argues that the cost is justified as Tzield (teplizumab) is the first drug that can delay the onset of type 1 diabetes, fending off the time when they become highly reliant on insulins and at risk of the serious complications that can accompany advanced T1D. It also has an option on global marketing rights to the drug.
The Pharma Data
AUGUST 17, 2021
approval of pump use for Lilly’s novel insulin is latest development designed to help people with diabetes manage blood sugar levels. Lyumjev, a novel formulation of insulin lispro developed to speed the absorption of insulin into the bloodstream and reduce A1C levels, was approved by the FDA in June 2020.
FDA Law Blog
FEBRUARY 7, 2022
Further, though any relevant discussion is redacted, the Untitled Letter suggests that FDA had previously provided comments to Lilly about its Trulicity promotion more generally. These issues are not new—although the fact that this is an Instagram post with video raises a new context for considering them.
The Pharma Data
AUGUST 17, 2021
Second FDA approved indication for dostarlimab in 2021 GARNET study demonstrated objective response rate of 41.6% This indication received accelerated approval based on tumour response rate and durability of response. This approval was based on data from cohort A1, which included 71 patients with dMMR endometrial cancer. [vii]
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