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Antibiotics Pipeline Is Lively, But Sponsors Are Fragile

 
• By Bridget Silverman

Regulatory uncertainty could imperil the crop of emerging companies making a go of it in the incentive-laden US anti-infective space.

Ski gates
Navigating the regulatory environment for antibiotics is a challenge • Source: Shutterstock

The global response to the antimicrobial resistance crisis has seen success using incentives to attract new specialty companies into the scientifically difficult and commercially unattractive infectious disease space, but now the young crop of sponsors with late-stage candidates must overcome a challenging regulatory environment in the US – and not all can be expected to succeed.

FDA has issued more than 100 designations to more than 60 product candidates under the Qualified Infectious Disease Product (QIDP)...

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More from Anti-infective

Moderna’s Spikevax Wins Pediatric Approval, But With Narrower Label

 
• By Alaric DeArment

The approval for young children, consistent with the FDA’s new COVID-19 vaccine policy, restricts Spikevax to those with conditions putting them at higher risk.

Four Chinese Firms Snag Global First-In-Class Approvals In China

 
• By Dexter Jie Yan

Four Chinese companies have won approvals in China, the first anywhere, for novel drugs for diffuse large B-cell lymphoma, certain types of non-small cell lung cancer and influenza A.

In Brief: BioVersys And Shionogi Align In Non-Tuberculous Mycobacteria R&D

 
• By Joseph Haas

Deal Snapshot: Having recently raised an $89m IPO, BioVersys is partnering on and optioning rights to a preclinical NTM development program with Shionogi.

Moderna Posts Phase III Efficacy Data For Flu Vaccine

 
• By Joseph Haas

With positive relative efficacy data for its mRNA seasonal flu shot, Moderna hopes to file mRNA-1010 for US approval and refile a COVID-19/flu combo shot that it withdrew in May.

More from Therapy Areas

Phase III Success For AstraZeneca’s $5bn Hypertension Hope Baxdrostat

 
• By Andrew McConaghie

Rivals Mineralys could be first to file but AstraZeneca is banking on its cardiovascular market know-how to lead the emerging class.

Leo Lands Another Big Pharma Pact With Boehringer Spevigo Deal

 
• By Kevin Grogan

Paying €90m upfront for rights to generalized pustular psoriasis drug.

Capricor Gets Complete Response For DMD Cell Therapy

 
• By Joseph Haas

Seven weeks before its action date, Capricor got an FDA complete response for cell therapy deramiocel in DMD-related cardiomyopathy. It has a Phase III study nearing readout, though.