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UK RNA Centre of Excellence opens
Centre for Process Innovation (CPI)’s new UK RNA Centre of Excellence combines development with scale up and clinical production in both mRNA manufacture and lipid encapsulation at a single site.
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Drug Development
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Report urges for new Pharma standards on antimicrobials
New recommendations from a report on antibiotic use and development has underlined key actions to help mitigate antimicrobial resistance (AMR) globally.
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New manufacturing facility could drive gold standard in cell therapy
A new manufacturing facility from the Novo Nordisk Foundation will be the first large-scale cell therapy production site in Denmark.
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New manufacturing facilities to enhance bioconjugate industry
Following WuXi Biologics’ proposed spin-off of its subsidiary, WuXi XDC has launched new manufacturing facilities that enable doubled capacity antibody intermediates and bioconjugate drug substances.
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sa-mRNA vaccine facilitates durable COVID-19 immunisation
A novel sa-mRNA vaccine has demonstrated the ability to provide prolonged protection against COVID-19 at lower doses, Phase I/II data shows.
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The benefits of mass spectrometry for expediting biologics to patients
A key element of development for new molecular format biological products is to leverage the appropriate analytical tools to enhance product and process understanding throughout the development lifecycle. Here, Ian Anderson, Mostafa Zarei and Qifeng Zhang at Lonza highlight the benefits of using mass spectrometry technologies to accelerate and de-risk product…
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CAR T therapy exhibits encouraging proficiency in R/R LBCL
The first study assessing Yescarta® as second-line therapy for transplant ineligible relapsed/refractory (R/R) large B-cell lymphoma (LBCL) demonstrated durable remission rate in a Phase II trial.
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First treatment for myelofibrosis with anaemia approved
The US Food and Drug Administration (FDA) has granted approval of a treatment for anaemic patients with a rare blood cancer.
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Advanced therapy collaboration network launched in Scotland
Advanced therapy (ATMP) manufacturers and developers in Scotland are set to be supported through a new collaboration initiative from the Cell and Gene Therapy Catapult (CGT Catapult).
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CHMP’s September 2023 meeting highlights
In its September 2023 meeting, the EMA’s human medicines committee (CHMP) recommended nine medicines for approval and the extension of therapeutic indications for 11 medicines.
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CPHI Pharma Awards 2023 finalists announced
The finalists for CPHI’s Pharma Awards 2023 across twelve categories for innovation, manufacturing, sustainability, best start-up initiative and breakthrough digital technologies have been announced.
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Small molecule drug shows promise in rare disease
In a Phase II trial, the small-molecule drug CBL-514 demonstrated significant reduction in lipoma size and pain improvement in Dercum's disease, a rare disorder.
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Pfizer’s migraine medicine recommended by NICE
The National Institute for Health and Care Excellence (NICE) has published final draft guidance on Pfizer’s Rimegepant, recommending it for the first time as a treatment for acute migraines.
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AstraZeneca partnership to pioneer UK’s first commercial biomethane supply
Part of AstraZeneca's £100 million renewable energy commitment involves a 15-year partnership to establish the UK’s first unsubsidised industrial-scale supply of biomethane, supporting sustainable pharmaceutical manufacturing.
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Achieving scale up success under economic uncertainty
Avoiding risk by studying past challenges and the lessons learned can help biotechs navigate the current uncertain macroeconomic climate, says Brandon Fincher, President of Early Stage Development & Testing at the CDMO Cambrex.
