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OxyContin wins 'abuse-deterrent' label, but FDA bans older generic forms

 
• By Donna Young

Three years after the FDA OK'd Purdue Pharma's reformulated version of its controlled-release oxycodone drug, OxyContin, the company won the coveted "abuse-deterrent" language in the medicine’s labeling.

Three years after the FDA OK'd Purdue Pharma's reformulated version of its controlled-release oxycodone drug, OxyContin, the company won the coveted "abuse-deterrent" language in the medicine’s labeling.

"This is the first time we have approved such language in opioid drug labeling, and we made this determination after carefully reviewing the available science," said Dr Douglas Throckmorton, deputy...

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Final Chance To Have Your Say: Take Scrip's Reader Survey This Week

 
• By Eleanor Malone

Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By Eleanor Malone

Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in the coverage topics, content format or the method in which you receive and access Scrip, or if you love it how it is, now is the time to have your voice heard.

Galapagos Expands Point-Of-Care CAR-T Study To The US

 
• By Andrew McConaghie

CEO Paul Stoffels said gaining US clearance for an IND for its novel CAR-T product was demanding, but now opens up a pathway towards a pivotal study starting in 2025.

Analysts Split On Eisai’s Chances Of Changing EU Regulator’s Mind On Leqembi

 
• By Andrew McConaghie

A final rejection of Leqembi could also spell the same fate for Lilly’s rival drug but public outcry and demand for Alzheimer’s therapies might force the regulator’s hand

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In Brief: Neurocrine Details New Data For Schizophrenia Drug Moving To Phase III

 
• By Sushmita Panda

Neurocrine reports new details of positive Phase II results in schizophrenia and a favorable safety and cardiovascular profile for its first-in-class oral M4 agonist, now moving to Phase III trials.

Astellas Gets CLDN.18.2-Targeted ADC From China’s Evopoint

 
• By Joseph Haas

Astellas will pay $130m up front for near-global rights to a Phase I/II antibody-drug conjugate that will add to its portfolio of CLDN.18.2-targeted drugs, including Vyloy.

Merck & Co./Daiichi Pull Patritumab Deruxtecan BLA On Disappointing OS

 
• By Jessica Merrill

Patritumab deruxtecan is the lead antibody drug conjugate in a $22bn deal signed between the two partners, with the decision marking a disappointing setback