XTalks

OCTOBER 22, 2021

Boehringer Ingelheim’s Cyltezo has become the second interchangeable biosimilar approved by the FDA, and the first approved interchangeable monoclonal antibody. In July 2021, the agency approved the first interchangeable biosimilar product, Semglee (insulin glargine-yfgn) for the treatment of diabetes.

FDA Approval 98

FDA Approval Production Insulin Antibody 98

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. mg and 2.4 mg doses of Wegovy.

FDA Approval 98

FDA Approval Containment Drugs Pharmacy 98

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.

Insulin 52

Insulin FDA Approval Doctors Doctor 52

Roots Analysis

FEBRUARY 22, 2022

Given the inherent benefits of autoinjectors, a number of players have launched their proprietary products in combination with autoinjectors for use across a wide array of disease indications. The generic version of EpiPen received the FDA approval in 2018. Rising Need of Autoinjectors – Roots Analysis.

Drug Delivery 52

Drug Delivery Production Marketing Development 52

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.

Insulin 40

Insulin FDA Approval Drugs Production 40

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]

FDA Approval 52

FDA Approval Antibody DNA Hormones 52

Drug Discovery World

JULY 13, 2023

The rules and regulations Unlicensed drugs are drugs that have not yet been assessed by a regulator, while off-label use is when an approved medication is prescribed outside of the terms of its license, e.g., for a different disease or in a different patient group. What are the risks?

Drugs 94

Drugs Medicine Regulation Licensing 94