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Discover the news and inspiring materials from the world of biotechnology.

Antibody drug conjugate for multiple myeloma.

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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JN.1 variant of SARS-CoV-2 virus.

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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Immunotherapy IL-15 agonist

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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Reform of EU pharmaceutical legislation ahead.

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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Lixisenatide effective in Parkinson's disease

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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Denosumab biosimilar for osteoporosis treatment.

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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Vaccine and syringe injection for prevention, immunization and treatment of coronavirus infection (COVID-19, nCoV 2019)

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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