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UK 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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Drug Safety
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Antibody-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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FDA 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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siRNA drug delivery across the blood-brain barrier in Alzheimer’s
Carrie Taylor, Director of Research & Development at BOC Sciences examines the key pathologies in Alzheimer’s and highlights several promising siRNA drug delivery systems that offer potential in helping to overcome the neurodegenerative disease.
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ESMO 2023: Janssen reveals data for intravesical delivery system
Phase IIb study results show evidence of sustained, durable complete responses beyond one year with an intravesical gemcitabine delivery system for a high-risk bladder cancer.
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Could Eli Lilly deliver first-line atopic dermatitis treatment?
Strong evidence of long-term efficacy of the IL-13 inhibitor lebrikizumab for atopic dermatitis has been demonstrated in Eli Lilly’s two-year extension trial.
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Counterfeit diabetes pens identified in EU and UK
Following shortages of the diabetes medicine Ozempic (semaglutide), the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) have confirmed cases of falsely labelled pre-filled pens at UK and EU wholesalers.
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EACS 2023: Gilead shares real-world evidence for Biktarvy®
Efficiency of Gilead Science’s long-term HIV treatment option with a high barrier to resistance has been further demonstrated in real-world data based on three-year study follow up.
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Regulatory-first for gene editing therapy
The world’s first investigational in vivo CRISPR-based gene editing therapy cleared for late-stage clinical development is expected to enter Phase III in late 2023.
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First-in-class phosphate absorption inhibitor approved by FDA
A first-in-class treatment with a differentiated mechanism of action has been approved to reduce serum phosphorus in chronic kidney disease (CKD) in individuals for which phosphate binders are not suitable.
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Sanofi treatment could slow type 1 diabetes progression
New Sanofi Phase III trial data adds to evidence of the treatment potential for the first disease modifying therapy in type 1 diabetes.
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NICE recommends Roche biologic for lymphoma
Glofitamab is the first treatment to be recommended by the National Institute for Health and Care Excellence (NICE) at the same time as it is approved for advanced lymphoma in the UK.
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Follicular lymphoma BTK inhibitor recommended by CHMP
Following the CHMP’s recommendation of a follicular lymphoma combination treatment, if approved, BRUKINSA will be the first BTK inhibitor to be authorised for follicular lymphoma.
webinar
Navigating challenges in HPAPI development and manufacturing
12 October 2023 | By Thermo Fisher Scientific (Patheon)
HPAPIs now account for more than half of clinical small molecule NCE drugs. Learn from our experts how to overcome the most common challenges in HPAPI handling.
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ECNP 2023: new esketamine NS safety data for depression
New safety data for a Phase IIIb study in treatment-resistant depression (TRD), revealed at ECNC 2023, showed that esketamine NS significantly increased the proportion of patients achieving remission compared to quetiapine XR.
