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CMS Finalizes Guidance on Medicare Part D Manufacturer Discount Program

FDA Law Blog

As part of this change, the Coverage Gap Discount Program (CGDP), a program that has existed since 2011, will sunset on December 31, 2024, and be replaced by the Medicare Part D Manufacturer Discount Program (the “Discount Program”). CMS will send the final manufacturer invoice for discount liabilities accrued by then on April 30, 2028.

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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). Abbott Spinal Cord Stimulation (SCS) Systems Manufacturer/developer : Abbott Medical Date of FDA approval : May 30, 2024 Approved for : Chronic, hard-to-manage pain in the torso, arms and legs.

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FDA approves Lyumjev® (insulin lispro-aabc injection) 100 units/mL for use in insulin pumps

The Pharma Data

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.

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The US biosimilar market: Predictions for 2021

pharmaphorum

One of these markets is the insulin market. Up until now, the insulin market has experienced little competition and, as a result, prices have soared over the years. Currently, more than seven million patients rely on insulin, and that number is growing each year. But, that will soon be changing, due to biosimilars.

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Biologic Therapeutics Development, Part 1: Definition and Distinct Characteristics

Camargo

Essentially, a biologic is a product that is produced from living organisms or that contains components of living organisms. They are often heat sensitive, membrane impermeable, subject to enzymatic degradation, and susceptible to microbial contamination (a factor which impacts manufacturing steps and quality considerations).

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Researchers Develop World’s First Saliva Test for Diabetes

XTalks

The test involves the use of testing strips that contain a glucose biosensor with electronic elements in the test’s transistor, like inks, that allow for mass printing of the test strips at low cost. Related: Droplet Micron Insulin Needle Offers Innovation in Crowded Diabetes Supply Market. Biosensor Technology.

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FDA Warns About Compounded Versions of Ozempic and Wegovy

XTalks

Ozempic and Wegovy, which contain the active ingredient semaglutide, were approved by the US Food and Drug Administration (FDA). 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.