Science News
Discover the news and inspiring materials from the world of biotechnology.
A biologic drug for diabetes effective in early Parkinson’s disease
Lixisenatide, a popular biologic for type 2 diabetes, was found to delay the progression of Parkinson’s disease in a Phase II clinical trial. However, larger studies are needed to confirm this finding and secure regulatory approval.
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First denosumab biosimilar approved by FDA
Sandoz has just won the race for the first FDA-approved biosimilar to denosumab. Approval spans all indications of the reference product.
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New RSV vaccines linked to rare neurological disorder
Preliminary data from the post-licensure studies of novel RSV vaccines point to an increased risk of Guillain-Barre syndrome (GBS), a serious neurological disorder. However, their vast benefits continue to outweigh the small risks.
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EMA considers dropping efficacy studies for certain biosimilars
EMA released a new concept paper which proposes waiving the clinical efficacy studies if biosimilar candidate demonstrates high similarity to the reference product at analytical level.
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Effectiveness of 2023-24 season COVID vaccines: First estimates are in
First studies estimating the effectiveness of updated COVID-19 vaccines have been published. Effectiveness against hospitalization was calculated at 70.7%-76.1% and against symptomatic SARS-CoV-2 infection at 54%.
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Monoclonal antibody targeting CD3 receptor preserves insulin secretion in early type 1 diabetes
Teplizumab, an anti-CD3 monoclonal antibody, was found to preserve the function of pancreatic β cells in newly diagnosed type 1 diabetes mellitus. Earlier, the drug has received FDA approval in the prevention of type 1 diabetes in high-risk individuals.
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Beacon Select System™ opens new technological chapter in Mabion
We are thrilled to announce that Mabion S.A. has recently acquired the cutting-edge Beacon Select™ System for cell line development (CLD).
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EMA and FDA investigating cancer signal for CAR-T therapies
EMA and FDA have started a safety review of CAR-T therapies following the notification of 23 cases of T-cell malignancies. The investigation involves all registered CAR-T products, which are used for treating relapsed and treatment-resistant hematologic malignancies.
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