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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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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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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Antisense therapy fails to delay the progression of Huntignton’s disease
A trial of investigational antisense therapy for Huntington’s disease, tominersen, has been halted early for lack of efficacy and possibly harm with more frequent dosing. However, the quest for effective therapy of Huntington’s disease is still ongoing and the developer of tominersen decided to continue research, this time enrolling younger patients with early disease.
Learn moreBispecific antibodies: success story continues
A great number of clinical studies confirmed high efficacy and safety of bispecific antibodies in the treatment of various cancers. Breaking results from another three, evaluating amivantamab, blinatumomab and tarlatamab, continue their success story.
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