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FDA approve GSK’s Jemperli for patients with dMMR solid tumours
GSK receives FDA accelerated approval for Jemperli for adults with mismatch repair-deficient (dMMR) recurrent or advanced solid tumours.
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Antibodies
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Lebrikizumab displays 75 percent skin clearance in dermatitis patients
Lebrikizumab achieved at least 75 percent skin clearance in more than half of patients with atopic dermatitis (AD), shows Phase III study.
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Advances in technology and manufacturing to promote plant-produced therapeutics uptake
Experts suggest investing in plant-based manufacturing systems could reduce costs and help scale up therapeutic protein manufacturing.
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ebook: Waiving intellectual property rights for COVID-19-related interventions and technologies: a comprehensive guide
This ebook explores the intellectual property rights waiver for COVID-19 treatments, vaccines, diagnostics and technologies, its potential ramifications for the drug development industry and potential solutions for overcoming COVID-19 vaccination inequalities.
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Monoclonal antibody prevents malaria in small NIH trial
One dose of a monoclonal antibody developed at the US National Institutes of Health (NIH) prevented malaria for up to nine months.
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Cell line development services market to value $2.4 billion by 2030
New report suggests the cell line development services market will witness a 14.3 percent CAGR between 2021 and 2030.
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Chikungunya vaccine effective in 98.5 percent of participants
Valneva’s single-shot chikungunya vaccine induced neutralising antibody titers in 98.5 percent of participants in a Phase III study.
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Saphnelo approved to treat systemic lupus erythematosus
AstraZeneca’s Saphnelo (anifrolumab-fnia) has been approved in the US for patients with moderate to severe systemic lupus erythematosus.
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NICE approves cost-comparison fast-track appraisal pilot
A new approach to the cost-comparison fast-track appraisal process is being piloted this summer for the review of low-risk appraisals.
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FDA approves emergency use of REGEN-COVTM for COVID-19 prevention
The FDA have authorised REGEN-COV monoclonal antibody therapy for emergency use as prevention for COVID-19 in certain patients.
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Bayer appoints Head of Research and Early Development for Oncology
Bayer have announced that Professor Dominik Ruettinger will be its new Head of Research and Early Development for Oncology, effective 1 October 2021.
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IL-6 antagonists reduce risk of death in hospitalised COVID-19 patients, finds analysis
WHO recommends IL-6 antagonists plus corticosteroids for hospitalised COVID-19 patients based on their ability to reduce risk of death and the need for mechanical ventilation.
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GSK to collaborate on development of antibodies for neurodegeneration
GSK will support the development of Alector’s immuno-neurology monoclonal antibodies for Parkinson’s disease, frontotemporal dementia and Alzheimer’s.
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EU approves Opdivo plus Yervoy for colorectal cancer
The European Commission approved Opdivo (nivolumab) plus Yervoy (ipilimumab) for certain metastatic colorectal cancers after a trial found the combination meaningfully improved response rates.
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Germany still second largest producer of EU-approved active biopharmaceutical substances, finds report
A new medical biotechnology report shows Germany’s biopharmaceutical industry is thriving with recombinant antibodies being a key focus area.
