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10 US Approval Decisions To Look Out For In Q3

 
• By Alexandra Shimmings

This quarter has already seen a complete response letter for Iterum Therapeutics’ antibiotic sulopenem but a raft of other products are expecting approval decisions from the US Food and Drug Administration in the next three months. With the help of analysts at Biomedtracker, Scrip takes a look at 10 of the more interesting ones.    

PDUFA Date: 5 July

A decision from the US Food and Drug Administration is imminent for AstraZeneca PLC’s anifrolumab for the treatment of systemic lupus erythematosus (SLE). If successful, it would be the...

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Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

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InflaRx Stock Sinks As Vilobelimab Fails Phase III Skin Trial

 
• By Kevin Grogan

A study of the German biotech's intravenous complement factor C5a antibody for pyoderma gangrenosum was stopped for futility.

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Insights from Novotech on Evolving Trends Impacting Global Clinical Development

Quick Listen: Scrip’s Five Must-Know Things

 
• By Ian Haydock

In this week's episode: Novo Nordisk’s CEO forced out; quantifying biopharma’s contribution to the US economy; a history of MASH deals; lift for AstraZeneca’s asthma ambitions; and major Japanese firms see US revenue growth.