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US FDA approves "grandfathered" oxycodone products

 
• By Anju Ghangurde

The US FDA has approved new drug applications (NDAs) for a line of controlled substance products containing oxycodone hydrochloride, said partners Lehigh Valley Technologies (LVT) and Glenmark Generics Inc, a US subsidiary of the Indian firm Glenmark.

The US FDA has approved new drug applications (NDAs) for a line of controlled substance products containing oxycodone hydrochloride, said partners Lehigh Valley Technologies (LVT) and Glenmark Generics Inc, a US subsidiary of the Indian firm Glenmark.

The approval gives LVT and Glenmark manufacturing and distribution rights to the only FDA-approved oxycodone immediate release capsules and oral...

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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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Xenon Nears Phase III Readout For Potential Epilepsy And Depression Blockbuster

 
• By Andrew McConaghie

Leading a field of rival potassium channel modulators, azetukalner will have a pivotal epilepsy readout early next year, with Phase III trials in depression and biopolar disorder also underway.

Stock Watch: Sanofi And Merck Temper Big Pharma Q2 Earnings Cheer

 
• By Andy Smith

The investor enthusiasm that greeted initial second-quarter pharma earnings announcements was dampened by the results from Sanofi and Merck & Co. Sanofi was particularly punished by investors despite overall growth, while Merck’s revenue fall was probably baked into expectations.

Japan Results Roundup: Reduced Forex Impact, Uncertain US Tariff Outlook

 
• By Lisa Takagi

Most major Japanese firms report generally positive fiscal first quarter results, led by mainstay growth and despite lower currency effects. But the future impact of any US pharma tariffs remains an overhang.