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African Countries Adopt Treaty To Set Up New Medicines Agency

African health ministers have agreed on a treaty to set up a new pan-African agency to coordinate regional drug regulatory harmonization initiatives and pool limited regulatory expertise.

Regulation Middle East and Africa

Greater Acceptance Of Extrapolation & Switching Boosts Biosimilars But Barriers Remain, Says Sandoz Exec

The biosimilars market is being boosted as physicians become more accepting of biosimilar switching and more willing to prescribe biosimilars on the basis of extrapolation of indications,. However, barriers – including misinformation – remain, as Carol Lynch, president of Sandoz US and chair of the biosimilar medicines group at Medicines for Europe, tells the Pink Sheet.


Biosimilars Europe

Price Cuts On MS Drugs Lead UK's NICE To Reverse Earlier Rejection

Avonex, Copaxone, Extavia and Rebif have all been recommended for use on England's National Health Service after their prices were reduced to improve their cost-effectiveness. However, Betaferon remains too expensive to be given a positive recommendation, according to the health technology assessment body, NICE.
Health Technology Assessment United Kingdom

Keep Us In The Loop: EMA Clarifies Expectations Following PRIME Kick-Off Meetings

New guidance from the European Medicines Agency explains how sponsors that have drugs in its priority medicines scheme should interact with its experts and committees.

Market Access Europe

Why Four In Five Applications For PRIME Still Fail Two Years On: EMA Clarifies Expectations

The European Medicines Agency’s priority medicines scheme, PRIME, attracts a lot of applications, but most of them fail. The agency has explained why and has updated it guidance documents for applicants.

Market Access Europe

EMA’s PRIME Is Driving Innovation, But Too Early To Tell If Drugs Will Reach Patients Faster

With just three marketing applications filed, the European Medicines Agency says it is too soon to say whether PRIME, its priority medicines scheme, is meeting its objective. The agency is satisfied, though, that the scheme has started to drive innovation.

Market Access Research & Development
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