All articles by CE – Page 50
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NewsDMT-SSRI combination shows potential for depression
A Phase Ib study evaluating selective serotonin reuptake inhibitors (SSRIs) interaction with SPL026, native N, N-dimethyltryptamine (DMT) in major depressive disorder (MDD) has revealed positive data.
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NewsLymphoma 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.
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NewsFirst 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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NewsAchieving pharmaceutical drug traceability compliance
A paper has highlighted a technology system for achieving drug traceability compliance and help prevent production of counterfeit drugs.
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NewsRadioligand therapy demonstrates novel first line benefit
Novartis’ radioligand therapy (RLT) is the first to demonstrate clinically meaningful benefit in a first line setting.
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NewsAnti-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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NewsAseptic packaging market to value $35bn by 2033
Factors contributing to the growth of the aseptic packaging market include a rising demand for biologics and vaccines and greater focus on sustainability, a report states.
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NewsNICE 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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NewsUK 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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NewsMHRA authorises novel pre-filled pen injector
Adtralza®(tralokinumab) has been granted a UK marketing authorisation by the Medicines and Healthcare Products Regulatory Agency (MHRA) to treat atopic dermatitis, halving the number of injections required.
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NewsReport 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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NewsNew 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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ArticleGene therapy: a radical pharmaceutical revolution
Karen Pinachyan, Head of Medical Affairs Europe at CSL Behring provides an overview of past and present gene therapy development, plus the progress of clinical trials and key challenges in the sector.
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NewsNew 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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Newssa-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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NewsEuropean Commission approves long-acting HIV drug option
The first long-acting injectable PrEP option proven superior to daily oral FTC/TDF in reducing HIV acquisition, has been approved in the European Union (EU).
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NewsCAR 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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NewsFirst 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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NewsAdvanced 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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NewsCHMP’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.