All Clinical Development articles – Page 22
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NewsFirst CRISPR-based gene-editing therapy authorised
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted a world-first regulatory authorisation to a medicine based on Nobel Prize-winning technology.
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ArticleAdvancing clinical development in haematology oncology
Newly appointed Vice President of Medical Affairs, Europe at BeiGene, Dr Jan-Henrik Terwey, provides exclusive insight on clinical development in the haematology/oncology space, and highlights significant data for its BCL-2 inhibitor, sonrotoclax.
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NewsCHMP recommends new immunotherapy delivery method
If approved, Roche’s Tecentriq subcutaneous (SC) would be the EU’s first injectable PD-(L)1 cancer immunotherapy.
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NewsCould GSK myelofibrosis treatment gain EU-first approval?
If approved, momelotinib will be the first treatment in the EU indicated for myelofibrosis patients with moderate to severe anaemia.
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NewsNovel siRNA therapeutic could lower cardiovascular disease risk
A Phase II trial for the small interfering RNA (siRNA) therapeutic lepodisiran is currently underway, assessing its ability to reduce lipoprotein(a) levels.
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NewsFirst chikungunya vaccine approved
Future regulatory authorisation is expected in Europe, following the US Food and Drug Administration (FDA)’s accelerated approval of IXCHIQ®.
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NewsTargeted therapy for hard-to-treat leukaemia subtype approved in EU
A FLT3 inhibitor that has been shown to significantly improve FLT3-ITD positive acute myeloid leukaemia survival has been authorised in the EU.
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ArticleDeveloping a first-in-class small molecule drug for inflammatory disease
In this exclusive Q&A, Dr Jenna Brager, Executive Vice President of Drug Development for MyMD Pharmaceuticals® explains to EPR why its oral small molecule drug could transform how TNF-α based diseases are treated.
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NewsInnovative insomnia study aims to overcome major clinical trial bottleneck
A new UK trial investigating a standard insomnia treatment is a “significant step forward in patient-centric trial design”.
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NewsGilead reveals positive data for potential first-line adenocarcinoma treatment
The only Fc-silent anti- T-cell immunoreceptor with Ig and ITIM domains (TIGIT) antibody in Phase III for upper GI adenocarcinomas could be the first to market for these cancers.
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NewsAAO 2023: intravitreal treatment shows benefit in geographic atrophy
Results from Iveric Bio’s Phase III trial demonstrated that over a two-year period, IZERVAY™ (avacincaptad pegol intravitreal solution) reduced geographic atrophy (GA) lesion growth as early as six months.
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NewsAntibiotics ‘no longer effective’ for childhood infections, finds study
Australian-led study highlights ‘alarmingly high’ rates of resistance to commonly-prescribed antibiotics in the Asia-Pacific region.
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NewsEuropean approval for third adapted COVID-19 vaccine
The European Commission has authorised the first protein-based adapted vaccine for COVID-19.
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NewsAlfasigma to acquire Jyseleca from Galapagos
Italy-based Alfasigma has agreed to acquire the Jyseleca (filgotinib) business from Belgian biotech Galapagos for €170 million.
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NewsMetformin helps manage weight gain side effect of SGAs
US study shows metformin has ‘modest but significant effect’ in helping to reduce weight gain in youths taking SGA medications to treat bipolar disorder.
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NewsNew Bill could enhance UK clinical trial regulation
According to a report on policy development in the UK, the Future Clinical Trials Bill will mandate transparent trial registration and facilitate quicker regulatory approval.
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NewsUK Clinical Trial Application submitted for amyloid-targeting drug
The Clinical Trial Application sent to the MHRA is for a combination drug with the potential to become a cost-effective treatment against early Alzheimer’s disease.
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ArticleAntibody-drug conjugates: paving the future of oncology clinical development
Dr Mark Rutstein, Senior Vice President, Head of Oncology Clinical Development at Daiichi Sankyo, highlights key data about the company’s antibody-drug conjugate (ADC) being investigated for breast and lung cancer, and shares insight into why ADCs could replace current standards of care in oncology.
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NewsFDA approves new therapy for myelodysplastic syndromes
The first targeted therapy for certain adults with the rare blood cancer myelodysplastic syndromes, has been approved by the US Food and Drug Administration (FDA).
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NewsCPHI selects 2023 Pharma Award winners
Progress, innovation and sustainability across the pharmaceutical supply chain were recognised at the 2023 CPHI Pharma Awards.