Science News
Discover the news and inspiring materials from the world of biotechnology.
Recombinant coagulation factor with extended half-life prevents bleeding in children with severe hemophilia A
A genetically engineered factor VIII concentrate with an extended half-life, almost completely prevented spontaneous bleeding among children suffering from hemophilia A. Unlike older FVIII preparations that require infusions every 2 or 3 days, the new drug can be administered once per week.
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Antibody-drug conjugates continue their victory march
The victory march of antibody-drug conjugates continues unabated. In two recent trials, benlatamab mafodotin was found to delay the progression of pre-treated or relapsed multiple myeloma outperforming the standard therapy.
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COVID-19 vaccines for 2024/25 season will target JN.1 variant
WHO and EMA published a recommendation to update the composition of COVID-19 vaccines for 2024/25 season to JN.1 variant. In recent months JN.1 has become the most widely circulating variant worldwide. It differs from the XBB variant included in the current season vaccines, causing substantial fall in their effectiveness.
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First-in-class IL-15 superagonist wins FDA approval
The first-ever superagonist of interleukin-15 (IL-15), with a highly unique structure, has just received FDA approval in the treatment of bladder cancer.
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Next step to revise pharmaceutical legislation made by EU parliament
European Parliament adopted a comprehensive pharmaceutical reform package to address drug pricing, accessibility, and safety concerns across the EU. Reform measures include enhancing price transparency, strengthening pharmacovigilance efforts, and streamlining regulatory processes to ensure patient access to safe and affordable medications.
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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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