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Eagle takes sporadic flight on US Ryanodex nod

 
• By Donna Young

The FDA granted Eagle Pharmaceuticals approval to market its orphan drug Ryanodex (dantrolene sodium) as a treatment for malignant hyperthermia (MH), an inherited and potentially fatal disorder triggered by certain anesthesia agents in genetically susceptible people.

The FDA granted Eagle Pharmaceuticals approval to market its orphan drug Ryanodex (dantrolene sodium) as a treatment for malignant hyperthermia (MH), an inherited and potentially fatal disorder triggered by certain anesthesia agents in genetically susceptible people.

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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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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.

Could There Be A Cure For Cardiometabolic Disease? Novo Nordisk Foundation Wants To Help Academics Find Out

 
• By Andrew McConaghie

The not-for-profit’s senior vice president Martin Ridderstråle explains how it is expanding grants for basic research to improve "human and planetary" health.

GSK Talks Up Nucala COPD Hospitalization Data In Challenge To Dupixent

 
• By Kevin Grogan

As the PDUFA date for the UK major’s IL-5 inhibitor draws close.