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

Pharmaceutical Technology

How will RFK Jr’s American dream for vaccines play out? 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.

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

Pharmaceutical Technology

How will RFK Jr’s American dream for vaccines play out? 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. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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Ultragenyx receives complete response letter for UX111 BLA

Pharmaceutical Technology

How will RFK Jr’s American dream for vaccines play out? 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.”

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

Pharmaceutical Technology

Robert Barrie July 30, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook Prasad, an oncologist who was a fierce critic of the Covid-19 vaccine response in the US, was appointed only three months ago. Prasad, an oncologist who was a fierce critic of the Covid-19 vaccine response in the US, was appointed only three months ago.

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Sarepta Therapeutics to cut 500 jobs amid restructuring

Pharmaceutical Technology

How will RFK Jr’s American dream for vaccines play out? 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. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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Moderna’s mRNA RSV vaccine wins expanded FDA approval for younger adults

Pharmaceutical Technology

Robert Barrie June 13, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook mRESVIA is the second approved product in the US for Moderna, along with its Covid-19 vaccine Spikevax. Until now, the vaccine was licensed for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults aged 60 years and older.

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Budget expectation: Bring GST rate on APIs at par with the formulations

Express Pharma

Initiatives such as Ayushmaan Bharat Digital Mission (“ADBDM”), CoWIN (a digital vaccine delivery platform), health registry, and telemedicine, highlight the government’s strong emphasis on digitisation of health in India. Expectation #4 Clarification on product samples and low brand value items – According to CBDT circular no.