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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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Clinical Trials
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Roche to gain rights to novel antibody for IBD
Roche is set to gain rights to develop, manufacture and commercialise a novel antibody treatment with first-in-class and best-in-disease potential for inflammatory bowel disease (IBD), under a new acquisition agreement.
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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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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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Targeting tumours with novel radiopharmaceuticals
In this exclusive Q&A, Dr Jack Hoppin, CEO, and Dr John Babich, Chief Scientific Officer of Ratio Therapeutics share their perspective on the evolving radiopharmaceutical landscape and why radiopharmaceutical therapeutics have significant potential in oncology.
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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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Novo Nordisk agrees $1.3bn hypertension acquisition
Novo Nordisk has set its sights on acquiring a medicine with best-in-class potential for hypertension from KBP Biosciences.
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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.
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Technical bulletin: Streamline your drug development pathway from preclinic to FIH/POC
No matter the industry, collaborations between multiple parties throughout a project pipeline can prove challenging.
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Research predicts 2029 small molecule oncology market leaders
With over $7 billion sales predicted by 2029, AstraZeneca’s Tagrisso is set to lead the lung cancer small molecule treatment market, according to GlobalData.
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Key developments in pharmaceutical manufacturing – September 2023
This article outlines the recent progress of several major new manufacturing facilities that will be central in supporting the production of innovative therapies in Europe.
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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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MHRA regulation overhaul: new scheme for lowest-risk UK clinical trials
The Medicines and Healthcare products Regulatory Agency (MHRA) states its new scheme enables a more streamlined approach to processing Clinical Trial Authorisations (CTAs) for initial applications in late-stage clinical trials.
