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Webinar: Advantages bringing early phase trials to North America
Watch Altasciences’ on-demand webinar to learn the key advantages and differences of conducting early phase clinical trials in North America.
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Drug Development
news
Lymphoma maintenance therapy delivers promise in CTCL
One of the largest clinical trials in cutaneous T-cell lymphoma (CTCL) to date could change current clinical practice, new data shows.
article
Considerations for safety data migration methods
Pharmacovigilance regulation in the EU and beyond has continued to grow and become more stringent over the last decade. In this article, ICON’s Graeme Bones explains how to handle the different types of data migration methods and how companies can select the optimum approach to ensure data integrity is maintained.
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First multiple sclerosis biosimilar approved in Europe
Sandoz’s monoclonal antibody Tyruko® has been approved for all indications of reference medicine, as the first biosimilar to treat relapsing forms of multiple sclerosis (MS) in Europe.
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Anti-PD-1 antibody gains EU approval for oesophageal cancer
Approval of BeiGene’s TEVIMBRA® (tislelizumab) in EU follows an agreement with Novartis to regain global rights of the antibody treatment.
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NICE recommends Eli Lilly ulcerative colitis biologic
The first IL-23p19 targeted biologic recommended by the National Institute for Health and Care Excellence (NICE) for moderately to severely active ulcerative colitis (UC) in adults in Great Britain is based on Phase III evidence of sustained clinical remission.
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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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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…
news
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.
news
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).
