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Role and Responsibility of Pharmacy Benefit Manager (PBM)

Posted on07 Sep 2021
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Pharmacy benefit manager (PBM) plays important function in pharma Market Access & Pricing (PM&A). For PBM, clients are health plans. PBMs handle some or all of the pharmacy benefit for health plans (formulary design, cost sharing and tiers, pharmacist networks and contracts, price concession negotiation with manufacturers). PBMs may own mail...
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Why Is Pharma Out-Licensing Its Compounds?

Posted on22 Jul 2021
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When you hear the term “in-licensing,” simply think of the word “investor“. In-licensing is the process of creating a contract that allows another firm to provide capital to the development and launch process, thus taking on financial responsibility. This is a very popular licensing process for small bio-pharma start-ups to...
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What is High Potency Active Pharmaceutical Ingredients?

High potency active pharmaceutical ingredients (HPAPIs) are pharmacologically active substances that exhibit biological activity at extremely low concentrations. Generally, high potency active pharmaceutical ingredients works well even in daily therapeutic dose of <10 mg or an occupational exposure limit (OEL) of < 10 μg/m3 at an eight hour time-weighted average....
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What is PDE value of API?

PDE stands for permitted daily exposure. PDE value of API is having prime importance after implementation of European Medicines Agency’s (EMA’s), ‘Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities (EMA/CHMP/CVMP/SWP/169430/2012). The importance of Health Based Exposure...
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