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Reining In “March In”: NIH Rejects Xtandi Petition

 
• By Ramsey Baghdadi

The National Institutes of Health is rejecting calls to exercise “march in” rights on patents for a cancer drug, declaring its view that the authority is narrowly focused on shortages – not pricing.

The National Institutes of Health’s decision to reject a petition asking the agency to use “march-in rights” on the patent for Astellas Pharma Inc./Medivation Inc.’s prostate cancer drug Xtandi (enzalutamide) without even holding a hearing takes one wild card approach to attacking drug prices off the table – at least until the end of the Obama Administration.

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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.

GLP-1 Drug Coverage Growing For Obesity In Medicaid, But Only For Diabetes In Medicare

 
• By Cathy Kelly

Coverage data from the two programs suggest Medicare beneficiaries may be more disappointed than Medicaid enrollees by the Trump Administration’s decision not to mandate the programs cover obesity drugs.

New Medicare Negotiation Program ‘Iterations’ Inevitable, Former CMS Official Blum Says

 
• By Cathy Kelly

Jonathan Blum, who was principal deputy administrator during the Biden Administration, explained the agency’s approach to setting up the price negotiation program and said changes likely will be implemented by the Trump Administration.

New Medicines Pricing Proposals Would Mean More Uncertainty For Spanish Supply Chains

 
• By Francesca Bruce

Proposals to reform Spain’s reference pricing system are out of whack with the national pharmaceutical strategy published in December, six industry associations have warned.

More from Pink Sheet

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.