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EMA joins FDA in wanting more Heplisav data

 
• By Alexandra Shimmings

Dynavax Technologies has had to withdraw its European marketing authorization application for its investigational hepatitis B vaccine Heplisav after all.

Dynavax Technologies has had to withdraw its European marketing authorization application for its investigational hepatitis B vaccine Heplisav after all.

It said the day 180 List of Outstanding Issues provided by the EMA indicated that the current Heplisav safety database was considered too small to rule out a risk of...

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A Short History Of MASH Deals, Culminating In GSK/Boston Pharma

 
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Both high-profile failures and small investments that are yielding success so far characterize the dealmaking in MASH over the past 15 years or so.

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Company surprises investors with Jørgensen's exit but insists its strategy will not change.

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Novo Nordisk Looks To Septerna For Oral Obesity Options

 
• By Mary Jo Laffler

Deal Snapshot: The Danish drugmaker is partnering with GPCR drug discovery expert Septerna to develop multiple small molecules for cardiometabolic targets.

More from Therapy Areas

All Over For iTeos But Applause For Plan To Return Cash Fast

 
• By Kevin Grogan

The company has moved quickly to wind down operations after its anti-TIGIT pact with GSK collapsed.

In Brief: Nicox Extends Cash Runway As Kowa Advances NCX 470 In Japan

 
• By Sushmita Panda

Eye drug is already in Phase III trials elsewhere, with results due in Q3. Nicox could earn up to a further €24.5m in milestones and royalties from Kowa alliance.

GSK’s Bet On Spero’s Oral cUTI Antibiotic Poised To Pay Off With New Phase III Data

 
• By Joseph Haas

Spero and partner GSK have Phase III non-inferiority data to support approval of tebipenem as the first oral antibiotic for complicated urinary tract infections.