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Market Access & Reimbursement

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Latest From Market Access

US FDA Pushes Back On Proposal For Early Clinical Designations To Support Higher Reimbursement Decisions

Breakthrough, RMAT designations signal clinical potential and are not intended to have reimbursement impact after approval, FDA says. 
Review Pathway Reimbursement

Shire, Microsoft and Eurordis Partner To Improve Diagnosis And Treatments For Rare Disease

An alliance between Shire, Eurordis and Microsoft to speed up diagnosis of rare diseases in children could lead to better access to treatments and the development of new medicines.

Market Access Policy

Praluent’s Price Cut: Testing The Tech Model For Drug Pricing

It may be more accident than design, but Sanofi and Regeneron are applying a tried and true pricing model to Praluent. Just ask tech companies. 
Pricing Strategies Cardiovascular

Regulators In Mexico, Chile And Colombia Take Steps Towards Regulatory Harmonization

Medicines regulators from the Pacific Alliance have taken a step towards greater regional regulatory harmonization in a bid to make registration of medicines faster.

South America Chile

Sofosbuvir Compulsory License Nears In Chile

Generic competition is nearing for hepatitis C medicines formulated with Gilead’s sofosbuvir in Chile, following moves by the health ministry to allow compulsory licensing.

South America Chile

China Talks Up AI, Big Data, Cancer Care But Approval, Coverage Huddles Persist

Leveraging the internet and big data to improve healthcare, regulatory efficiency and cancer treatment are among the priorities singled out by the Chinese Premier at the annual National People's Congress meeting. Some delegates say drug approval and coverage challenges remain, while industry observers point to commercial insurance as a solution to drive the specialty market such as cancer care.

China Policy
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