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GSK eyes FDA label expansion for RSV vaccine Arexvy to include younger patients

Pharmaceutical Technology

Robert Barrie July 14, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook Broader label coverages for Pfizer and Moderna’s vaccines mean they have made in-roads into GSK’s RSV dominant market share. A decision by the FDA is expected in H1 2026. MAXSHOT.PL via Shutterstock.

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JCR Pharma and Alexion partner on JUST-AAV gene therapy platform

Pharmaceutical Technology

JCR values its partnership with Alexion, and we are pleased to build on the collaboration we have developed over the years.” The financial impact of this agreement on JCR’s consolidated results for the fiscal year ending 31 March 2026 has already been included in the current earnings forecast.

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Ultragenyx receives complete response letter for UX111 BLA

Pharmaceutical Technology

The company is confident that these concerns, which pertain to facilities and processes rather than product quality, can be promptly addressed. While the CRL will delay the potential approval of UX111 to 2026, we are working with urgency to respond and resubmit.” Efforts are underway to work with the FDA to resolve them.

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Prasad’s FDA exit may accelerate cell and gene therapy approvals

Pharmaceutical Technology

The future of DMD drug development now hinges on who steps into the role and how the FDA navigates this high-profile therapeutic area.” ” The public playout of DMD treatment developers with the FDA is not only impacting biopharma share prices but also raising concerns about the agency’s internal operations.

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Sarepta Therapeutics to cut 500 jobs amid restructuring

Pharmaceutical Technology

Sarepta Therapeutics is set to cut 500 jobs as part of its restructuring and pipeline prioritisation plan, which is expected to result in annual cash cost savings of $120m in 2026. With its pipeline reprioritisation, the company anticipates delivering $300m in annual non-personnel cost savings from 2026.