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Takhzyro Among Hopefuls For EU Approval Recommendation

 
• By Maureen Kenny

A handful of companies are expected to find out this week whether their products will be recommended for EU approval. The EMA's drug evaluation committee, the CHMP, is due to give its opinion on marketing authorization on two orphan drugs for use in HAE and myotonia respectively, another biosimilar trastuzumab, and a flu vaccine.

Question
What will the CHMP decide this month? • Source: Shutterstock

Just a couple of months after securing US approval for its new treatment for the prevention of hereditary angioedema (HAE) attacks, Shire is due to find out this week whether lanadelumab (Takhzyro) is likely to be approved in the EU.

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French Bill Could Improve Clinical Research, But Further Action Is Required

 
• By Francesca Bruce

France’s simplification bill is a “first step” to improving the country’s clinical research environment, but more could be done to drive decentralized trials and simplify processes, says Leem, the French pharmaceutical industry association.

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New Carbon Monitoring Initiative Could Help Future Proof Clinical Research

 
• By Francesca Bruce

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More from Geography

EU Regulators Push For Better Support For Sponsors On Using Animal Study Alternatives

 
• By Eliza Slawther

The European Medicines Agency’s innovation network has recommended how the EU’s regulatory framework could be updated to support drug developers in using new approach methodologies, which are drug testing methods that reduce or replace animal studies.

New US FDA Roadmap Moves Closer To Animal Testing Alternatives

 
• By Bridget Silverman

New plan to encourage alternatives to animal testing seeks interagency cooperation to meet more aggressive targets for transformational change than the US FDA’s long-standing program.

HHS’ Kennedy Warns US FDA Staff Against ‘Agency Capture’ By Industry, Special Interests

 
• By Sue Sutter

HHS Secretary Robert F. Kennedy Jr. urged FDA staff to resist the “deep state” and “crony capitalism,” and focus on improving the health of America’s children. “You're not here to take orders,” he said and urged FDA staff to speak up if they see wrongdoing.