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Viruses

New HIV drug formulation could transform paediatric administration

4 August 2023 | By Catherine Eckford (European Pharmaceutical Review)

The first fixed dose combination (FDC) formulation containing dolutegravir that is suitable for certain paediatric HIV patients globally, has been deemed safe and effective by US researchers.

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MHRA authorises new COVID-19 vaccine

2 August 2023 | By Catherine Eckford (European Pharmaceutical Review)

The new COVID-19 vaccine authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) contains an adjuvant and is indicated to be given to patients over 16 years.

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First continuous mRNA manufacturing platform to be developed

17 July 2023 | By Catherine Eckford (European Pharmaceutical Review)

Design of the world’s first continuous mRNA manufacturing platform, an $82 million, three-year, FDA-funded project aims to help accelerate development of mRNA technologies.

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Chikungunya vaccine demonstrates 99 percent immune response

13 June 2023 | By Catherine Eckford (European Pharmaceutical Review)

If approved, VLA1553 could become the first licensed chikungunya vaccine available to address this unmet medical need.

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Big Pharma inventory management trends revealed

31 May 2023 | By Catherine Eckford (European Pharmaceutical Review)

Rapid growth of Big Pharma manufacturer inventories fail to prevent medicine shortages, a 2022 report has highlighted.

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Nanoparticle HIV vaccine shows potential in trial

25 May 2023 | By Catherine Eckford (European Pharmaceutical Review)

Positive first-in-human trial results have highlighted potential of a nanoparticle vaccine towards broadly neutralising against HIV.

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Intratumoural viral delivery improves glioblastoma survival

17 May 2023 | By Catherine Eckford (European Pharmaceutical Review)

“Injecting a virus into a patient’s brain tumour” combined with immunotherapy improved glioblastoma survival outcomes in a clinical trial.

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Recent developments in stem cell therapies

16 May 2023 | By Catherine Eckford (European Pharmaceutical Review)

EPR explores recent developments in stem cell therapies across several hard-to-treat diseases and how technology is transforming ATMP manufacture.

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RWE shows efficacy of nirsevimab for infant RSV

15 May 2023 | By Catherine Eckford (European Pharmaceutical Review)

New real-world data “adds to the evidence that use of long-acting monoclonal antibody [nirsevimab] may prevent moderate to severe respiratory syncytial virus disease” in infants after single dose.

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Antibody response varies for Big Pharma COVID vaccines

9 May 2023 | By Catherine Eckford (European Pharmaceutical Review)

Pfizer, Moderna and Johnson & Johnson COVID-19 vaccines produced varied neutralising antibody levels when assessed for short- and long-term response, says study.

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First RSV vaccine approved for older adults

4 May 2023 | By Catherine Eckford (European Pharmaceutical Review)

The US Food and Drug Administration (FDA) has approved the first-ever vaccine for respiratory syncytial virus (RSV) in adults over 60 years old.

article

Realising the potential of AAV gene therapies

27 April 2023 | By Dr Rajiv Vaidya (Andelyn Biosciences)

In this article, Dr Rajiv Vaidya, Head of Manufacturing Science & Technology at Andelyn Biosciences, explores strategies for improving the scalability and cost‑effectiveness of AAV production while maintaining regulatory compliance.

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Moderna’s mRNA vaccine manufacturing centre begins construction

26 April 2023 | By Catherine Eckford (European Pharmaceutical Review)

Moderna achieves another milestone in its UK government partnership, with the start of construction of its mRNA vaccine manufacturing centre.

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CHMP meeting highlights – March 2023

3 April 2023 | By Catherine Eckford (European Pharmaceutical Review)

In the European Medicines Agency's March human medicines committee meeting, nine new medicines were recommended, including one for multiple sclerosis.

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SMC accepts treatment for chronic hepatitis delta virus

14 March 2023 | By Catherine Eckford (European Pharmaceutical Review)

Bulevirtide has been accepted by the Scottish Medicines Consortium to treat chronic hepatitis delta virus (HDV) infection in adults.

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