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MiddleBrook launches first Pulsys formulation, Moxatag

 
• By John Davis

MiddleBrook Pharmaceuticals has launched Moxatag, the first once-daily amoxicillin tablet to be marketed in the US, more than a year after it was approved by the FDA.

MiddleBrook Pharmaceuticals has launched Moxatag, the first once-daily amoxicillin tablet to be marketed in the US, more than a year after it was approved by the FDA.

Moxatag is also the first product to use the company's Pulsys drug-release technology.

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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

 
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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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Removal Of REMS For CAR-Ts Could Greatly Expand Their Reach

 
• By Alaric DeArment

The FDA eliminated REMS requirements for approved CAR-T cell therapies that have limited their availability, a move that could enable increased use in the community setting.

Deal Watch: Novartis To Develop Cardiovascular Therapies With ProFound

 
• By Joseph Haas, Sushmita Panda, Jung Won Shin, and Alaric DeArment

Plus deals involving BioCryst/Neopharmed Gentili, Sanofi/Kymera, Abion, Denovo/Chuang Yi, Carisma/OrthoCellix, Otsuka/Harbour Biomed, Aptose/Hanmi, Philochem/RayzeBio, Concentra/Elevation Oncology, and more.

What Incyte Investors Expect From New CEO Bill Meury

 
• By Andrew McConaghie

Fresh from having sold Anthos to Novartis, the new CEO is expected to update the oncology and dermatology-focused firm's strategy.