Markets & Regulations

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FDA decision on Pfizer’s maternal RSV vaccine expected by August

By Rachel Arthur

The US Food and Drug Administration (FDA) has accepted Pfizer’s Biologics License Application (BLA) for its maternal RSV vaccine under priority review. If approved, the vaccine will become the first RSV vaccine for pregnant women to protect against RSV...

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EU approves first gene therapy for hemophilia B

By Jonathan Smith

Three months after receiving the US green light, CSL’s candidate Hemgenix has become the first gene therapy to gain EU approval for the treatment of hemophilia B.

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Finch halts biotherapeutic trial and axes 95 per cent of its staff

By Liza Laws

Finch Therapeutics announced its shock decision to discontinue the PRISM4 Phase 3 trial of CP101 in recurrent C. difficile infection (CDI) yesterday (Jan 25) saying instead it will focus on ‘realizing the value of its intellectual property estate and...

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Lonza: Robust industry fundamentals are supportive of growth

By Jane Byrne

Despite an uncertain macroeconomic environment, Lonza says its ‘resilient’ business model and sustained market demand delivered a strong financial performance in 2022, in line with the Swizterland based CDMO’s outlook.

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Needle-free future: Tackling vaccine delivery challenges

By Jane Byrne

Biotech company, Vaxxas, has secured a partnership agreement with the Coalition for Epidemic Preparedness Innovations (CEPI) to advance the development of its needle-free vaccine-patch delivery technology for mRNA vaccines.

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Lumen Bio: ‘We face 2023 with tremendous optimism’

By Jane Byrne

Lumen Bioscience has been highlighting recent progress made on its clinical and regulatory journey while also announcing several funding milestones supporting the development of its therapeutics to prevent serious diarrheal diseases.

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