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Market Access & Reimbursement

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Latest From Market Access

Accelerated Assessment Decision ‘Imminent’ For Two Products In EMA’s PRIME Scheme

The sponsors of two products in the European Medicines Agency’s popular PRIME scheme for speeding patient access to drugs for unmet medical needs appear to be close to filing their applications for marketing authorization. Five more products were accepted on the scheme this week.

Europe Drug Review

Rejigging The Benefit-Risk Balance For Advanced Therapies In The EU

The European Medicines Agency’s Committee for Advanced Therapies has revealed its priorities for addressing the challenges manufacturers face in the fast-growing field of advanced therapies.

Research & Development Regulation

Why Most Regenerative Therapy Applications for US RMAT Designation Fail to Make The Grade

“It didn’t take long for folk to start applying,” a US Food and Drug Administration official says of the 17 applications the agency has received so far for designation under its new regenerative medicine advanced therapy (RMAT) program for fostering the development of such products.

Review Pathway Market Access

AbbVie Scores HCV First Under UK’s Early Access Scheme

AbbVie’s investigational hepatitis C treatment has become the latest therapy to get the green light under the UK’s early access to medicines scheme. The scheme enables patients to access the treatment ahead of it receiving an EU marketing authorization.

Market Access Drug Review

Stability At Last For Drug Innovators And Pricing In Australia

The Australian government has promised not to implement any new therapeutic groups under the Pharmaceutical Benefits Scheme for the next five years, nor will it introduce any new pricing reforms without consulting the innovative drug industry first.

Pricing Strategies Market Access

Turkey Spinraza Access Scheme Falls Far Short Of Demand

Turkey has agreed to provide the high-priced spinal muscular atrophy drug Spinraza for free to up to 20 children, but has so far not been able to reach an agreement with the producer to procure the drug at a reduced price or add it to the reimbursement list.

Policy Turkey
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