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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

HHS mRNA Vaccine Wind-Down Has Limited Impact (And One Contract Isn’t Even mRNA)

 
• By Alaric DeArment

The news will have a big impact on pandemic preparedness but less immediate financial impact. Tiba Biotech was even “caught off guard” by its inclusion in the department’s culling of mRNA vaccine projects under BARDA, as its project was neither a vaccine nor mRNA-based.

Gilead’s Yeytuo, Lilly’s Kisunla Headline CHMP Positive Opinions

 
• By Alaric DeArment

Yeytuo will have remaining challenges to PrEP to overcome, while Kisunla’s label reflects dosing titration data from a Phase IIIb study to mitigate ARIA-E.

Memo Therapeutics Plans BK Virus Therapy Phase III Despite Trial Miss

 
• By Manas Mishra

Pointing to data that show a benefit in reducing viral load and the histological signs of the infection, Memo says its drug, potravitug, could become the first therapy to treat BK polyomavirus in kidney transplant recipients.

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.

More from Therapy Areas

Genmab/AbbVie’s Epkinly Likely To See Label Expansion After Phase III Win

 
• By Alaric DeArment

The FDA is expected to rule on the anti-CD20xCD3 bispecific combined with rituximab/lenalidomide in second-line follicular lymphoma in November.

Sanofi’s Sarclisa Wins Another EU Multiple Myeloma Nod In Its Unequal Battle With J&J’s Darzalex

 
• By Sushmita Panda

The French drugmaker's anti-CD38 antibody has racked up another approval in first-line multiple myeloma, but it marks a small victory while the company develops a subcutaneous version to help level the field with J&J’s Darzalex.

Jazz’s Modeyso Approved For Rare Glioma With Expansion Targeted

 
• By Jessica Merrill

The accelerated approval came three months after Jazz completed the acquisition of Modeyso’s developer, Chimerix.