“We have to have an open and honest discussion about whether the guard rails are really appropriate for a country like Germany, because we’ve seen innovative products opting out from Germany and this is not the way to go.” – EUCOPE’s Alexander Natz discusses a new German law and flaws in the country’s pricing system. Find out more: New German Research Law Fails To Stop Companies From Opting Out Of The Market
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.
More from International
• By
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.
• By
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.
• By
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
• By
The Australian Therapeutic Goods Administration proposed a narrower indication that Eisai rejected.
More from Pink Sheet
• By
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.
• By
Novartis is planning to file EU and US marketing applications for an intrathecal formulation of its spinal muscular atrophy gene therapy, Zolgensma, in H1 2025.
• By
A new annual report from China's CDE shows a rise in overall product approvals but a fall in the transition rate for conditional to full approvals, possibly signalling more stringent requirements.