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Emphasys on the Block after FDA Panel Rejection

 
• By Tom Salemi

Emphasys Medical, following negative recommendation from an FDA panel, put itself up for sale.

The end is near for Emphasys Medical Inc. At the end of March, the company's ongoing business and assets will be put up for auction, serving as an disappointing end to the company's nine-year effort to get its Zephyr endobronchial valve to market. But although Emphasys likely will be gone, company executives hope the buyer will push forward, putting enough muscle behind the device to get the Food & Drug Administration’s approval.

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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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Moderna Punts On US Vaccine Policy Changes, Will Focus More On Cancer

 
• By Joseph Haas

On its Q1 earnings call, Moderna avoided criticizing policy changes affecting vaccines but de-emphasized its flu/COVID-19 vaccine for under-50 and prioritized cancer programs.

Zepbound Grows, But CVS/Novo Nordisk Deal For Wegovy Casts Shadow

 
• By Alaric DeArment

Lilly executives told the company’s Q1 call they were not surprised at the Wegovy deal, but some analysts said it could cut into prescription growth for Zepbound.

Scrip M&A Podcast: Will FDA Staff Cuts Impact Biopharma Dealmaking?

 
• By Joseph Haas

Attorneys Andrew Goodman and Alan Minsk, as well as Naya CEO Daniel Teper, discussed the ramifications of US FDA staff cuts on M&A activity with Scrip senior writer Joseph Haas.