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Teva and Cobalt challenge key US patents for Sepracor's Lunesta

 
• By Nancy Faigen

Sepracor has received notice that Teva Pharmaceutical Industries and Cobalt Laboratories have filed ANDAs for generic versions of the sleep agent Lunesta (eszopiclone) tablets, which gained US regulatory clearance in December 2004.

Sepracor has received notice that Teva Pharmaceutical Industries and Cobalt Laboratories have filed ANDAs for generic versions of the sleep agent Lunesta (eszopiclone) tablets, which gained US regulatory clearance in December 2004.

Both ANDAs contain paragraph IV certifications alleging that one or more of Sepracor's patents listed in the FDA's Orange Book...

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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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Merck & Co. Remains In The BD Game After Verona Takeout

 
• By Jessica Merrill

CEO Rob Davis said the company is in pursuit of more deals as it looks to close the revenue gap looming from the loss of Keytruda in 2028.

Asia Deal Watch: JXR And Alexion Build Upon Existing Gene Therapy Alliances

 
• By Joseph Haas, Lisa Takagi, Sushmita Panda, and Anju Ghangurde

Plus deals involving TandemAI/Perpetual Medicines, Biocytogen/BeOne, Chugai/Gero, CStone/Istituto Gentili, Alembic/Utility, Brii/Joincare, HanchorBio/Henlius, Rakuten/Cyntec and more.

Ultragenyx and Mereo Still Confident Despite Setrusumab Slip Up

 
• By Kevin Grogan

The osteogenesis imperfecta drug stumbled in a second interim analysis.