Pharmaceutical Technology

OCTOBER 12, 2022

Novo Nordisk has recently completed its six-part ONWARDS Phase III trial, as ONWARDS 5 reached its primary endpoint with Icodec demonstrating non-inferiority in reducing hemoglobin A1C (HbA1c) in patients with type 2 diabetes (T2D) at week 52 in comparison to once-daily basal insulin analogs. Patients had an overall baseline HbA1c of 8.9%

Insulin 182

Insulin Trials Marketing FDA Approval 182

Camargo

OCTOBER 14, 2020

In this situation, the timing and content of amendments following tentative approval can be complicated; Camargo can help sponsors navigate the process. Approval of the Month: FDA Approves First Closed-Loop Monitoring and Drug Delivery Device. Senior Director of Regulatory Compliance and Submissions.

Development 196

Development Insulin Drug Delivery Production 196

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.

FDA Approval 98

FDA Approval Containment Drugs Pharmacy 98

XTalks

JUNE 12, 2023

Internationally, Medtronic expanded its MiniMed 780G insulin pump and Guardian 4 sensor. Additionally, Abbott launched over 125 new products in 2022, in conjunction with a series of FDA approvals. These approvals reinforced the company’s position as a global leader in eye health. billion ($22.83 billion USD), a 20.65

FDA Approval 98

FDA Approval Production Sales In-Vitro 98

Roots Analysis

FEBRUARY 22, 2022

The generic version of EpiPen received the FDA approval in 2018. In compliance with laws and legislations for the prevention of needlestick injuries, most autoinjectors have an integrated safety device. One of the most widely recognized autoinjector in the market is EpiPen® (Mylan), which is a prefilled epinephrine autoinjector.

Drug Delivery 52

Drug Delivery Production Marketing Development 52