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While You Were Out: News In Brief

 
• By Joseph Haas, Emily Hayes, Mandy Jackson, and Mary Jo Laffler

Updates from the holiday season include a Phase III failure for Pfizer's MRSA vaccine, AbbVie's submission of upadacitinib for rheumatoid arthritis and several year-end US approvals and FDA actions. 

Picture showing group of friends having fun with sparklers - Image

Braeburn Pharmaceuticals Inc. said on Dec. 23 that the US FDA approved its buprenorphine depot injection Brixadi for patients undergoing treatment for moderate to severe opioid use disorder (OUD), but it was a tentative approval that delays the launch and yields additional competitive ground to Indivior PLC's Sublocade (buprenorphine extended-release).

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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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GSK Chief Optimistic About BD Despite Volatile Environment

 
• By Kevin Grogan

Emma Walmsley tells Scrip that the "biotech market is under a certain degree of pressure," so reasonably priced deals are available.

Quotables: Pharma Leaders On The Month’s Hot Topics

 
• By Anabel Costa-Ferreira

The highlights of recent comments and insights from industry executives on the key issues covered in Scrip.

In Brief: AbbVie’s Rinvoq Secures US Approval For Giant Cell Arteritis

 
• By Sushmita Panda

JAK inhibitor gains ninth indication in US after a strong performance in the first quarter.