STAT

OCTOBER 23, 2024

Food and Drug Administration to bar compounding pharmacies from making copies of its blockbuster weight loss drug semaglutide, arguing that the medication is too complex for the pharmacies to safely make , STAT reports. Novo has repeatedly argued that compounded products are risky, stressing that they are not approved by the FDA.

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Compounding Compounding Pharmacies Biosimilars Documentation 255

Express Pharma

JUNE 5, 2023

billion in 2031 across the 8MM, registering a compound annual growth rate (CAGR) of 1.9 Jakafi’s landmark approval in 2011 galvanised intensive drug development efforts by providing a strong positive investment signal for this market, as Jakafi is a blockbuster agent. billion in 2021 to $2.89

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Drug Development Biosimilars Compounding 97

European Pharmaceutical Review

JULY 4, 2024

4,6 Five patent issues that European biosimilar developers should consider before entering the US market Quality control of the botanical drug substances was one of the critical factors that led to barricades during the development of Veregen and Mytesi. 13 Currently, over 350 herbal remedies have been granted a THR licence. 2012/1916).

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Drug Development Biosimilars Documentation Labelling 103

FDA Law Blog: Biosimilars

DECEMBER 3, 2023

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”). Kirschenbaum — The Inflation Reduction Act (IRA) significantly changed the Part D benefit.

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Labelling Drug Pricing Compounding Payment Processing 105