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Market Access & Reimbursement

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Latest From Market Access

Brexit: Number Of Drugs At Risk Of Shortage Cut From 108 to 39

The European Medicines Agency plans to work directly with the marketing authorization holders of products that are still at risk of supply shortages to address the outstanding issues.

Brexit Regulation

Stress Test For WHO’s Quality Certificate Scheme In The Americas

A project being run in the Americas will assess the way that the Certificate of a Pharmaceutical Product is used and whether it meets the needs of countries in the region. The move is part of the revision of the World Health Organization’s quality certification scheme.
Quality Regulation

English Court Queries EMA Primacy & Says Avastin Can Be Used In AMD

The English High Court has rejected attempts by Novartis and Roche to stop clinical commissioning groups from offering Avastin to wet AMD patients in a cost-containment move. In a development that has alarmed pharma firms, the court also questioned the exclusive role of the European Medicines Agency in marketing authorizations, saying that CCGs as well as the health technology assessment body, NICE, have competences in that area, and called on the UK regulator to review its guidance on off-label and unlicensed use.

Reimbursement Regulation

Novo Nordisk CEO Says Group Doubling Medical Supplies in UK Ahead Of Brexit

Novo Nordisk's chief says the Danish company is stockpiling medicines in case of "no deal" hard Brexit

Brexit Business Strategies

Northern Ireland Improves Access To Cancer Drugs Fund Treatments

Measures announced by the Northern Ireland department of health to bring access to cancer treatments in line with other parts of the UK are expected to make the region more attractive for clinical research.
BioPharmaceutical Europe

HHS Secretary Alex Azar Talks Rebate Changes, But Not Eliminating Discounts Altogether

Details on anticipated changes to rebate practices are in demand. HHS Secretary Azar talked about changes that would still allow negotiated discounts at the point of sale during a presentation at the FT Pharma Pricing and Value Summit.

Market Access Pricing Debate
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