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CRISPR-based microbial gene therapy delivers promise
A microbial gene therapy can “eliminate antibiotic-resistant E. coli strains in the gut”, according to first-in-human study interim results.
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Therapeutics
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Big Pharma inventory management trends revealed
Rapid growth of Big Pharma manufacturer inventories fail to prevent medicine shortages, a 2022 report has highlighted.
webinar
Strategies for implementing eConsent across the European regulatory landscape
30 May 2023 | By Medable
In this webinar, we dive into the intricacies of implementing electronic informed consent (eConsent) in clinical trials within the complex regulatory landscape of European countries.
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European Commission approves haematology biosimilar
A marketing authorisation for a biosimilar to eculizumab has been granted by the European Commission for paroxysmal nocturnal haemoglobinuria.
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CHMP meeting highlights – May 2023
The Committee for Medicinal Products for Human Use (CHMP) recommended two new medicines for approval in its May meeting, including a neurosteroid for epileptic seizures.
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Overcoming bottlenecks in the advanced therapy supply chain
Professor Dr Martin Bornhäuser of University Hospital Carl Gustav Carus Technische Universität Dresden discusses the cell therapy bottleneck and why advanced therapy tracking systems could offer a solution.
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New recognition routes to fast-track UK medicine access
New recognition routes will facilitate faster and safer access to innovative medicines through seven international partners, according to the UK’s MHRA.
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Life sciences sector to receive £650 million funding
Funding to support the UK's life sciences manufacturing, skills and infrastructure has been announced as part of a £650m growth package.
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Nanoparticle HIV vaccine shows potential in trial
Positive first-in-human trial results have highlighted potential of a nanoparticle vaccine towards broadly neutralising against HIV.
whitepaper
Scientific journal: Planning your first-in-human trial
This issue of The Altascientist provides a thorough review of the first-in-human clinical trial process, including planning and conduct.
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Five proposed biosimilars planned for development in Europe
The extended partnership agreement between Alvotech and Advanz Pharmaceutical includes a biosimilar candidate to Entyvio® (vedolizumab).
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First redosable gene therapy approved
The “landmark approval” of a redosable gene therapy for dystrophic epidermolysis bullosa “ushers in a whole new paradigm to treat genetic diseases".
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European biotechs choosing Switzerland as base, research shows
The trend for European biotech companies to headquarter in Switzerland appears to be continuing, according to research.
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Machine learning can predict outcomes for inkjet printed pharmaceuticals
A paper has shown how machine learning (ML) models predicted the inkjet printing printability of drug formulations with high accuracy.
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Benefits of blockchain in limiting counterfeit drug distribution
Smart contracts on blockchain could help prevent distribution of counterfeit drugs in the pharmaceutical supply chain, a review shows.
