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Sanofi Wins FDA Nod for Merilog, First Rapid-Acting Insulin Biosimilar

XTalks

The FDA has approved Sanofis Merilog (insulin-aspart-szjj) as the first rapid-acting insulin biosimilar product for the treatment of diabetes. Merilog is a biosimilar to Novo Nordisks NovoLog, a widely used rapid-acting insulin aspart. Approximately 8.4 Approximately 8.4

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Lilly’s new drug Mounjaro (tirzepatide ) wins US FDA approval

pharmaphorum

It was also compared to a placebo, a GLP-1 receptor agonist (semaglutide) and two long-acting insulin analogues. more than placebo when used in combination with a long-acting insulin. more than insulin degludec and 1.0% more than insulin glargine. more than insulin degludec and 1.0% more than insulin glargine.

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Top 30 New Medical Devices of 2024

XTalks

TriClip G4 System Manufacturer/developer : Abbott Medical Date of FDA approval : April 1, 2024 Approved for : Tricuspid regurgitation (TR). Date of FDA approval : March 29, 2024 Approved for : To detect exposure to human parvovirus B19. TriClip size comparison photo. Photo courtesy of Abbott Medical.

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Provention’s Tzield can delay type 1 diabetes. But will it reach all patients?

Pharmaceutical Technology

On November 17, 2022, the FDA approved Provention Bio’s Tzield (teplizumab) , making it the first and only treatment to delay the onset of type 1 diabetes (T1D). The international T1D network TrialNet’s research was instrumental in the FDA’s approval of the first drug to delay T1D in at-risk people.

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Newly Approved T1D Therapy Lantidra Could Eliminate Need for Insulin Injections

XTalks

The treatment is derived from deceased donor pancreatic cells and is indicated for patients who are unable to achieve average blood glucose levels (glycated hemoglobin) with daily insulin injections or with continuous infusion through a pump because of repeated episodes of severe hypoglycemia (low blood sugar).

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Cyltezo Becomes First FDA-Approved Interchangeable Humira Biosimilar

XTalks

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.

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In the News: September Regulatory and Development Updates

Camargo

The FDA has also recently launched the Software Pre-Certification Pilot Program to provide an efficient regulatory framework for developers of SaMD products. FDA Issues Guidances Dealing with ANDAs. Approval of the Month: FDA Approves First Closed-Loop Monitoring and Drug Delivery Device.