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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.

The sale may be seen as a failure on the part of company management, but president and chief executive officer...

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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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Finance Watch: Sarepta’s Debt Woes Grow With Elevidys Shipment Pause

 
• By Mandy Jackson

Public Company Edition: Sarepta restructured after stopping shipments of its Elevidys for some patients to ease future debt pressures, but now it has stopped shipments to all patients. Also, Madrigal secured up to $500m in new debt, Cogent closed a $230m offering and other financings.

Avalyn Raises $100m Series D To Advance Inhaled Pulmonary Fibrosis Candidates

 
• By Joseph Haas

Looking to improve on the efficacy and safety of Roche’s Esbriet and BI’s Ofev, Avalyn has inhalable formulations of those drugs in Phase IIb and Phase I, respectively.

AstraZeneca Pledges Big Investment In US Manufacturing Amid Tariff Threats

 
• By Alaric DeArment and Sarah Karlin-Smith

The drugmaker plans to build a large manufacturing center in Virginia as the centerpiece of an effort to invest $50bn in the US by 2030.