“We want an agreement, and we clearly state that companies are willing to commit to binding mandatory obligations to share, whether it's with the WHO, GAVI UNICEF or UNITAID, for rollout to those with the highest medical needs, provided the system is workable.” – International Federation of Pharmaceutical Manufacturers and Associations’ outgoing director general Thomas Cueni on the WHO pandemic treaty. Find out more: 'Don’t Compromise The Pharma Innovation System,' Says Outgoing IFPMA Head Thomas-Cueni
Quotable: Top Experts On Policy Hot Topics
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
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Cell and gene therapy manufacturers must consider the practicalities of their product within the context of a health care system before it comes onto the market to be successful, experts from Novartis, AstraZeneca and England’s National Health Service say.
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A global collaborative inspections pilot reduced the number of individual inspections for participating manufacturing facilities, demonstrating that multiple regulatory authorities can carry out joint inspections using a mix of on-site and remote approaches.
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The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
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The Australian Therapeutic Goods Administration proposed a narrower indication that Eisai rejected.
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The European Medicines Agency has recommended five drugs for EU-wide approval , including Averoa’s Xoanacyl for concomitant hyperphosphatemia. Two companies have withdrawn their marketing authorization applications.
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Eli Lilly’ will request a re-examination after the European Medicines Agency declined to recommend its Alzheimer’s disease drug Kisunla for EU approval.
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Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.