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EMA recommends Idefirix (imlinfidase) is granted marketing authorisation
The European Medicines Agency (EMA) recommended Idefirix is granted conditional marketing authorisation for highly sensitised patients awaiting kidney transplant.
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Antibodies
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Second of Lilly’s COVID-19 neutralising antibodies begins Phase I trials
The first patient has been dosed in the Chinese Phase I trial of JS016 in healthy people who do not have a COVID-19 diagnosis.
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Lilly launches Phase I trial of investigational COVID-19 antibody treatment
The enterprise announced the initiation of the LY-CoV555 COVID-19 antibody treatment trial at medical centres across the US.
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‘At home’ COVID-19 antibody tests: expert opinions and manufacturer warnings
Abbott has revealed its SARS-CoV-2 antibody test was not designed for at home use despite companies selling them for this purpose. Also, what do experts think about these tests?
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COVID-19 vaccine induces immune response in Phase I trial
The adenovirus type 5 vectored COVID-19 (Ad5-nCoV) vaccine candidate safely induced T cell and antibody responses in 108 adults.
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FDA grants priority review to Biologics License Application for sutimlimab
The FDA has granted priority review of the Biologics License Application for sutimlimab to treat haemolysis in patients with cold agglutinin disease (CAD).
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Under the microscope: Highly potent APIs and toxic payloads
Dr William Sanders discusses trends in the development and manufacture of highly potent active pharmaceutical ingredients (HPAPIs) and toxic payloads for antibody drug conjugates (ADCs).
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SGS’s Centre of Excellence for Biosafety contributes to the fight against coronavirus
Developing new vaccines to fight emerging diseases is an ongoing fight and ensuring they are pure is vital to patients’ health and safety.
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Eli Lilly’s COVID-19 therapies to enter clinical trials
The enterprise announced its drug OLUMIANT® (baricitinib) and an investigational antibody will enter clinical trials in US COVID-19 patients later this month.
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Siltuximab – testing a potential COVID-19 therapy
Interim results from the SISCO study at the Papa Giovanni XXIII Hospital in Italy have demonstrated the promise of siltuximab as a treatment for the symptoms of COVID-19. Lee Morley explains how the drug works and the next steps for its development.
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COVID-19 and big pharma: what are 15 leading companies doing to develop a coronavirus vaccine?
A new report has revealed the vaccine R&D efforts of 15 of the leading pharmaceutical companies to combat the COVID-19 coronavirus.
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Novel microneedle array developed to deliver COVID-19 vaccine to mice
Researchers have created a microneedle array that successfully delivered a COVID-19 vaccine to mice, allowing them to produce antibodies against the virus.
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Study evaluates if siltuximab benefits COVID-19 patients with respiratory complications
The SISCO study will assess if the anti-IL-6 antibody siltuximab can aid patients suffering Acute Respiratory Distress Syndrome as a complication of the COVID-19 coronavirus.
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Clinical programme to evaluate Kevzara® as COVID-19 treatment begins
Led by Sanofi and Regeneron, clinical trials to examine Kevzara (sarilumab) as an effective COVID-19 treatment will begin in the US.
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Drug delivery method leads to sustained HIV antibody production in study
Using AAV-based technology to deliver mAbs in a Phase I trial, researchers report that participants successfully developed antibodies against HIV.
