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Basilea's Ceftobiprole On TARGET, Needs Positive Second Study For US

 
• By John Davis

The first pivotal Phase III study required for US approval of Basilea’s ceftobiprole has reported positive topline results; a second study is expected to read out in 2021.  

Staphylococcus aureus
Staphylococcus aureus, a target for ceftobiprole • Source: Shutterstock

The US market, particularly for MRSA therapies, is pivotal for the overall commercial success of new antibiotics, and the Swiss biotech, Basilea Pharmaceutica Ltd., needs good results from both ongoing Phase III studies of its rapid-acting broad-spectrum intravenous cephalasporin, ceftobiprole, to launch in that market, an event penciled in for 2022.

Ceftobiprole is already marketed in the EU and other ex-US markets by licensees and distributors, as Zevtera, and has just achieved positive top-line results in the Phase III TARGET study...

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Summit’s Ivonescimab Shows Significance On PFS, But Not Overall Survival

 
• By Joseph Haas

In a study intended to show similar benefit in western patients, PD-1/VEGF-targeting ivonescimab met a progression-free survival endpoint, but missed on OS.

Sanofi Bid For Second COPD Approval Hurt By Mixed Itepekimab Data

 
• By Kevin Grogan

One Phase III trial hits but a second study misses by a mile.

In Brief: Neurocrine Details New Data For Schizophrenia Drug Moving To Phase III

 
• By Sushmita Panda

Neurocrine reports new details of positive Phase II results in schizophrenia and a favorable safety and cardiovascular profile for its first-in-class oral M4 agonist, now moving to Phase III trials.

Merck & Co./Daiichi Pull Patritumab Deruxtecan BLA On Disappointing OS

 
• By Jessica Merrill

Patritumab deruxtecan is the lead antibody drug conjugate in a $22bn deal signed between the two partners, with the decision marking a disappointing setback

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Senti’s Computer-Logic Inspired Cell Therapy Shows Early Promise

 
• By Andrew McConaghie

The biotech believes its logic-gated cell therapies can get round the need for ‘clean targets’ which limit CAR-Ts and ADCs.

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.