All articles by Dominic Tyer (European Pharmaceutical Review) – Page 5
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News
ICH opens consultation on Q3E drug impurities guideline on leachables
Draft publication is set to expand its frameworks for new medicinal products, including cell and gene therapies.
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News
Trump executive order targets US pharma supply chain resilience
Calls for active pharmaceutical ingredient (API) stockpile to cover around 26 ‘critical drugs’.
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AbbVie invests $195m to expand API manufacturing in the US
The pharma company will add to its existing Chicago site, boosting its active pharmaceutical ingredient production capacity.
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NewsPureTech taps ex-Teva CEO to run its new respiratory unit Celea
Sven Dethlefs will be tasked with driving its deupirfenidone programme in idiopathic pulmonary fibrosis.
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NewsBionova Scientific opens pDNA facility in the US
The CDMO’s new site will support its work in cell and gene therapy.
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NewsNovartis scores Phase III wins for two ianalumab indications
Late-stage trials in Sjögren’s disease and primary immune thrombocytopenia met primary endpoints.
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NewsVinay Prasad returns to lead vaccines and cell and gene therapy at the FDA
CBER head makes surprise comeback just weeks after his abrupt resignation.
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News
Lilly to sell off Branchburg site as its US manufacturing plans take shape
The pharma company’s digital innovation efforts also progress with the opening of a new Hyderabad facility.
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NewsFDA to encourage new manufacturing sites with its PreCheck programme
The scheme will provide more support and a streamlined application process to companies constructing new US facilities.
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News
EU Biotech Act public consultation opens for input
The European Commission hopes its planned legislation will enable biotechnology companies to bring products from laboratory to market more quickly.
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News
mRNA vaccine research worth $500m cut by RFK Jr
HHS throws out Pfizer, CSL Seqirus and Sanofi proposals, and will restructure AstraZeneca and Moderna projects.
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NewsSanofi accelerates towards its ‘factory of the future’ vision
New digital initiative will support the pharma company’s manufacturing and supply chain ambitions.
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NewsOfichem acquires Uppsala site from Meribel Pharma Solutions
The deal between the two European CDMOs expands Ofichem’s Nordic biotech footprint and drug substance capabilities.
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Article
Amid FDA turmoil Sarepta’s gene therapy worries begin to ease
But the impact of George Tidmarsh’s CBER appointment after Vinay Prasad’s abrupt resignation remains to be seen.
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