Luminary Group’s Post

FTC BACKS FDA'S BIOSIMILAR SHIFT The Federal Trade Commission's endorsement of the FDA's plan to remove the switching study requirement for interchangeable biosimilars marks a significant step toward fostering competition and reducing healthcare costs. This change is poised to accelerate the entry of biosimilars into the market, benefiting both companies and patients alike. At Quality Executive Partners, Inc. (QxP®), we understand the impact this regulatory shift will have on the biosimilar landscape. Our expert team is ready to help guide your organization through these changes, ensuring you capitalize on the opportunities they present. Discover how our tailored consulting services can support your biosimilar development in this evolving market. https://lnkd.in/ddxAgMkm #pharma #biopharma #biotech #qualityassurance #biosimilars

Thoughts on this? >> FTC backs FDA plan to remove switching study requirement for interchangeable biosimilars >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #pharmaceutical #healthcare #biotech #productmarketing #pharma

Thoughts on this? >> FTC backs FDA plan to remove switching study requirement for interchangeable biosimilars >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #pharmaceutical #productmarketing #biotech #healthcare #pharma

🔥🔥 HOT TOPIC🔥🔥. Join us for what is to be a great webinar diving into the world of GLP-1s and Biosimilars. #glp1 #biosimilars #webinar #hottopic #employeebenefits #hr #benefits #beintheknow #palmerandcay

If you work in the Human Resources, Employee Wellness or Financial Management capacity of an organization but have no clue what GLP-1s and Biosimilars are(or their costs)you should be registering for this webinar🙂

#RegulatoryUpdate ICH Adopts M13A Guideline on Bioequivalence Testing. The International Council for Harmonisation (ICH) recently adopted its M13A guideline, which aims to harmonize the framework for assessing the bioequivalence (BE) of immediate-release (IR) solid oral dosage forms and assessing BE after post approval changes. The guideline aims to eliminate the need for sponsors to conduct additional BE studies due to divergent regulatory requirements to support marketing authorizations in different jurisdictions. Additionally, the guideline covers BE study designs, including study populations, study designs, the test and comparator products, fasting and fed study conditions, the dose or strength to be studied, and the moieties to be measured. This shall come into effect on January 25th 2025.   Read More: https://lnkd.in/dZZvTzED #RegulatoryHarmonisation

The vanza triple combination as a next-generation successor to Trikafta (elexacaftor/tezacaftor/ivacaftor), a triple combination CFTR modulator therapy that’s widely approved for patients with F508del and other eligible mutations. The vanza triple contains tezacaftor, one of the same modulators used in Trikafta, alongside two novel modulators called vanzacaftor (VX-121) and deutivacaftor (VX-561).

In addition to responding to technological changes and increased demand for drugmakers to become more patient-centric in their development, the biopharma industry is also under more regulatory pressure this year. Learn more about the ‘ins and outs’ of the Inflation Reduction Act and new EU regulations and how collaborating with an experienced partner can help you prepare for a tsunami of regulations. https://ow.ly/R9t750SBykj

A new study published by JAMA, Yale Engineering’s Julie Zimmerman and Hanno Erythropel, together with Yale researchers across campus, have revealed troubling discrepancies in e-cigarette products marketed with nicotine analogs. Tobacco companies are now using these analogs to potentially bypass FDA regulations. The study found significant mismatches between labeled and actual nicotine analog levels, with some products containing artificial sweeteners and synthetic agents not previously identified in vaping products. This raises serious concerns about health risks and regulatory oversight. 🔗 Click to read the full JAMA article here: https://loom.ly/AIlD0To #ChemicalEngineering #EnvironmentalEngineering #NicotineResearch #TobaccoRegulation #PublicHealth #YaleEngineering #VapingRisks

If you want a better understanding of the new drug prices for 2024, this article does a good job explaining what is causing the differences and how that might impact the consumer. https://lnkd.in/g-NcVmNd