EU Pharma Revision Of Hospital Exemptions For ATMPs 'Is Unsatisfactory'
The EU legislative overhaul falls short on dealing with the issue of hospital exemptions for advanced therapies, says the Alliance For Regenerative Medicine.
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The forthcoming overhaul of the EU pharma legislation should not include an expansion of the hospital exemption provision for advanced therapies, warn industry and regulators.
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.