Early Advice Could Help Companies Maintain EU Conditional Marketing Authorizations
The number of conditional marketing authorization non-renewals could increase.
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The European Medicines Agency has OKd nine new medicines for EU-wide approval, but recommended against renewing the conditional marketing authorization of two drugs.
Germany’s Confidential Pricing Move Could Protect Companies From Potential Trumpian US Reference Pricing
Confidential pricing would give companies more flexibility to negotiate discounts and prevent withdrawals.
In spite of successfully appealing against previous negative guidance, Pfizer has again failed to secure a positive recommendation from England’s health technology appraisal institute for Oxbryta for hemolytic anemia caused by sickle cell disease, and has been asked to provide more evidence.