Pharma's Preferred Patent Reforms May Be Too Expensive

Sen. Schumer supports exempting Rx industry from inter partes review, but tells BIO conference that legislators must find $1.2 billion to enact it; calls for industry code of conduct on pricing.

Sen. Charles Schumer, D-NY, is in favor of exempting biopharma companies from the Patent and Trademark Office's inter partes review proceedings. However, he said industry may have to be content with modifying the process if legislators are unable to find $1.2bn in pharma-related cost savings.

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Pharma Exhales, Dodges Financial Blow With Tariff Exemption

 

Industry lobbing for pharmaceuticals to be exempt from President Trump’s sweeping US tariffs appears to have paid off.

Dramatic HHS Layoffs A Response To ‘Existential Crisis,’ Kennedy Advisor Argues

 
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Calley Means defended reductions in force at the Health and Human Services Department that shocked and outraged federal workers and stakeholders.

Makary Pledges To Uphold Gold Standard Science, But First Address Confuses Some US FDA Staff

 

Some employees were not impressed with FDA Commissioner Martin Makary's first speech to the agency staff, saying he did not seem to understand the agency's mission.

Are Bigger Ad Policy Changes Coming After US FDA’s Drug Promotion Office Hit Hard By Layoffs?

 
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The loss of policy analyst, legal, project manager and social scientist positions has experts wondering if the Trump Administration is eyeing a broader effort to limit DTC advertising. The OPDP layoffs are expected to result in delayed reviews of promotional pieces.

More from North America

Will They Or Won’t They? Tariff Questions Loom For Drugmakers

 

Pharma executives and investors are waiting with bated breath to find out if President Trump will include drugs in a new round of tariffs to be announced on 2 April.

CDRH Staff Cuts Focus On Administrative Workers, Spare Reviewers

 

One CDRH employee said the cuts already are having a major effect on morale.

Updated: US Likely To Lose Its First Approver Advantage After FDA Layoffs

Mass FDA layoffs on 1 April were designed to spare product reviewers, but still touched many who are critical to the application review process or drug development, which could mean fewer treatments are brought to the US market first.