'Right to Try' Has White House Support: Add-On To PDUFA Looks Tough To Stop

The 'Right to Try' movement is gaining momentum at the federal level with support from both the Trump Administration and Republicans in Congress to enact legislation that would direct FDA not to interfere with existing state laws and allow terminally ill patients to access unapproved treatments.

Mike Pense

The “Right to Try” movement now has the explicit backing of the White House and enactment of legislation to prevent FDA from interfering with state laws in that area may now be inevitable.

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Trump Tariffs: Indian Pharma Dodges Bullet, But Sword May Remain

 
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Trump announced a 26% reciprocal tariff on India, but a country-agnostic exemption of pharmaceuticals implies that the interests of Indian firms are protected for now. What is Indian pharma’s business exposure and what is domestic industry saying?

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.

US FDA Commissioner Nominee Recruiting More Hill Staff Ahead Of User Fee Reauthorization

 

Republican congressional staffers could bring a wealth of experience and strong contacts with key legislators to the FDA ahead of the next user fee reauthorization process. But will Health and Human Services Department leadership interfere?

EU HTA Regulation: Companies Can Talk To National Authorities As ‘Substitute’ For EU-Level Advice

 

Not all companies will be able to access joint scientific consultations under the EU Health Technology Assessment Regulation, but success is still possible for those that engage with national agencies early on, says EUCOPE’s Alexander Natz.

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Early Randomization Among Advice On How To Meet Both EMA & HTA Needs

 

Newly published insights from a series of European Medicines Agency workshops can guide drug developers in designing development plans that meet the needs of both regulators and health technology assessment bodies.

AI Could Be Used ‘In The Deliberation’ Of HTA Reviews In England, Says NICE

 

England’s health technology assessment institute, NICE, is looking to “reimagine” its evaluation process with the help of AI, rather than just using this technology to speed up its existing processes.

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.