All articles by Catherine Eckford (European Pharmaceutical Review) – Page 44
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NewsmRNA researchers awarded 2023 Nobel Prize
The Nobel Prize in Physiology or Medicine 2023 has been awarded to two researchers who were instrumental in helping to curb the COVID-19 pandemic, through their discoveries in mRNA base modifications.
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NewsWill novel antibiotic become front-line for C. difficile?
Based on positive Phase II data, the first-in-class antibiotic candidate ibezapolstat for C. difficile is expected to advance to Phase III trials more quickly.
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NewsFDA approves first-in-class antidepressant
The first antidepressant with a novel mechanism of action that selectively targets the serotonin 1A receptor has been approved for major depressive disorder (MDD) by the US Food and Drug Administration (FDA).
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NewsChemo-free regimen demonstrates efficacy in NSCLC
Topline results from a Phase III study in NSCLC suggest that Rybrevant® and lazertinib could advance treatment beyond tyrosine kinase inhibitor (TKI) monotherapy.
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NewsAI-supported spectroscopy delivers superior pharmaceutical packaging QC
A combination of mid-infrared spectroscopy and artificial intelligence (AI) achieved excellent prediction capability for inline pharmaceutical packaging content verification, a study has shown.
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NewsTakeda ulcerative colitis biologic receives FDA approval
A new route of administration for a biologic to treat ulcerative colitis (UC) has been approved in the US.
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NewsEuropean PFAS restriction could jeopardise pharmaceutical manufacturing
Pharmaceutical manufacturing in Europe is at risk of critical medicine shortages, states the European Federation of Pharmaceutical Industries and Associations (EFPIA), if the widest chemical substance restriction, concerning Per- and Polyfluoroalkyl Substances (PFAS), is put in place.
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OpinionGuaranteeing resilience in vaccine manufacturing
Nicolas Chornet, Senior Vice President of Resilience Operations at Moderna provides insight on how vaccine manufacturers can secure resilience in an environment of rapid technological advancement.
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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.