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AlloVir Gains Third RMAT Designation For Antiviral T Cell Therapy

Could Help Prevent Infection In 40,000 Patients

 
• By Andrew McConaghie

Gaining the special regulatory status in a prophylactic setting for posoleucel is the most significant yet for the T cell therapy developer.

Cell Separator
A cell separator collects stem cells for use in an allogenic hematopoietic stem cell transplant. • Source: Alamy

Allovir has been lifted after posoleucel, its lead off-the-shelf (allogeneic) T-cell therapy to treat and prevent viral diseases, was awarded a third Regenerative Medicine Advanced Therapy (RMAT) designation to potentially speed up approval in the US.

Shares in the US biotech rose 18% after the firm reported that the US Food and Drug Administration granted the...

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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

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.

Verona’s COPD Launch Success Sealed Merck Buyout Interest

 
• By Andrew McConaghie

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Sumitomo Parkinson’s Filing A Pivotal Moment For Japan’s iPSC Ambitions

 
• By Lisa Takagi

Sumitomo Pharma's iPSC therapy for Parkinson's has been filed for approval in Japan after showing safety and efficacy in a Phase I/II trial and may become one of the first such therapies to reach the market in the country, which has invested heavily in the modality.