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FDA lifts partial clinical hold on Arrowhead drug

 
• By Lisa LaMotta

Arrowhead Research got a bit of good news on 13 April when the FDA cleared a partial clinical hold for the firm's chronic hepatitis B infection drug ARC-520, allowing Arrowhead to go ahead with a planned Phase IIb study for the drug.

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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

More from Scrip

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.