Express Pharma

DECEMBER 2, 2024

The company’s Phase III product Rybelsus, already FDA approved for cardiovascular risk factors and type 2 diabetes, is being positioned for a label expansion to include obesity. With a projected launch in 2026, it represents Eli Lilly’s bid to expand the company’s dominance in the GLP-1R category.”

Labelling 126

Labelling Diabetes Drug Development 126

Putting Patients First Blog

JULY 2, 2024

1 And we appreciated CMS’ thorough responses to comments for IPAY 2026 and hope the Agency will replicate this for this comment opportunity. These elements were previously highlighted in our comments in response to the IPAY 2026 guidance, and we continue to stress their importance for the 2027 draft guidance.

Drug Pricing 52

Drug Pricing Insurance Coverage and Processing Labelling HIPAA 52

Putting Patients First Blog

JANUARY 27, 2025

3 ,4, 5 As such, the NHC supports CMS proposal to ensure that Part D sponsors cover AOMs for obesity with clinical criteria that is not more restrictive than the FDA labeling for each AOM. However, we urge CMS to consider broadening eligibility criteria to include individuals who are overweight but have not yet developed these conditions.

Insurance Coverage and Processing 40

Insurance Coverage and Processing Biosimilars Communication Department of Veterans Affairs 40

Pharmaceutical Technology

MAY 9, 2023

Revenue prospects for Novo Nordisk’s blockbuster diabetes and weight-loss drug semaglutide in Brazil have been dealt a major blow after a federal court denied a request by the Danish firm for two patent extensions. Ozempic has been approved for diabetes in Brazil since 2018, joined by Rybelsus in 2020 and Wegovy in January this year.

Diabetes 59

Diabetes Labelling 59

Pharmaceutical Technology

JANUARY 10, 2023

Type 2 diabetes (T2D) is a crowded and competitive landscape with multiple “me-too,” generic and biosimilar drugs entering the market, with market growth primarily driven by an increasing prevalent population across nine major markets (9MM: US, France, Germany, Italy, Spain, UK, Japan, China, and India).

Biosimilars 52

Biosimilars Labelling Diabetes Compounding 52

Safe Biologics

APRIL 10, 2023

Significantly for the INN group, a 2020 WHO report identified inconsistent nomenclature as a remaining challenge as it is clear that naming and labelling are both very important for pharmacovigilance and prescribing. This year’s theme was “Improving Patient Care.”

Biosimilars 130

Biosimilars Drug Pricing Diabetes Labelling 130