All Therapeutics articles – Page 47
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NewsEMA validates MAA for novel telomerase inhibitor
Following European validation of its Marketing Authorisation Application (MAA), imetelstat has potential to become a standard of care in lower risk myelodysplastic syndromes (MDS), according to Geron’s CEO.
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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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ArticleCPHI Barcelona 2023 - Event preview
CPHI Barcelona takes place in October 2023, covering a wide range of topics from next generation biomanufacturing and formulation to sustainability.
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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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Whitepaper
ebook: Accelerate the development of your biologics
Altasciences’ Proactive Drug Development can accelerate the development of biologics by up to 40%, from lead identification to clinical POC.
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Video
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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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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ArticleConsiderations 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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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.