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UK scientists trial Humira biosimilar for COVID-19 in care homes

pharmaphorum

Adalimumab – sold by AbbVie as Humira as well as in biosimilar form by companies including Novartis’ Sandoz unit, Amgen and Biogen/Samsung joint venture Bioepis – will be used in the phase 2 AVID-CC study to see if it can prevent progression to respiratory failure in people with coronavirus infections.

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CMS Issues Sweeping End-Of Year Rule on Medicare Advantage and Medicare Part D

Putting Patients First Blog

CMS is proposing setting a 20% coinsurance/equivalent copayment limit for behavioral health services, eliminating cost-sharing for opioid treatment program services, and capping inpatient psychiatric service cost sharing to 100% of Medicare Fee-For-Services levels.

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CMS Final Medicaid Drug Rebate Rule Details New Misclassification Penalties and Numerous Other Changes

FDA Law Blog: Biosimilars

physicians services or inpatient hospitals services) and for which Medicaid payment may be made as part of payment for the service “and not as direct reimbursement for the drug.” 1396r-8(k)(3).

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Does the Drug Shortage White Paper Fall Short?

FDA Law Blog: Biosimilars

To address the underlying causes of shortages, the White Paper suggests that the creation (by Congress) of two programs that link inpatient hospital purchasing and payment decisions to supply chain resilience practices would better incentivize investments in mature manufacturing practices.

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Contents

RX Note

. - Drug registration number Medicines (Advertisement & Sale) Act 1956 and Regulations - To learn prohibitions of medicine advertisement and Medicine Advertisement Board Registration of Pharmacists Act 1951 and Regulations - Pharmacy Board Malaysia and legislation aspects of provisional, full and temporary registration Code of Ethics for Pharmacists (..)

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FDA Would Like to Join You in the Sandbox When Developing AI Enabled Devices

FDA Law Blog: Biosimilars

inpatient hospital, out-patient clinic), date range for the data, and location of the data collection sites (e.g., OUS data may introduce bias if the OUS population does not reflect the U.S. population due to differences in demographics, practice of medicine, or standard of care. The DCP may also define the sources of the data (e.g.,