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Could acoziborole eliminate sleeping sickness in Africa?
Acoziborole showed significant success in clinical studies, suggesting it could simplify treatment and help eradicate sleeping sickness.
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Drug Safety
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First paediatric EC approval of HIV drug
The European Commission has granted the first paediatric marketing authorisation for Gilead's low-dose Biktarvy® HIV tablet.
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NEJM publishes lecanemab Alzheimer’s study results
Full study results of Eisai’s Phase III Alzheimer's study suggest lecanemab could slow disease progression.
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First adaptive clinical trial for flu
A £2.9 million trial, the first adaptive platform trial studying flu treatments, could reduce serious illness in patients.
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Nasal spray could help prevent depression relapse
SPRAVATO® nasal spray helped treatment-resistant depression patients remain remission and relapse free in a Phase III trial.
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First patient dosed with novel RNA modifying enzyme inhibitor
A Phase I trial for solid tumours has begun to assess STC-15, the first RNA methyltransferase modifying enzyme inhibitor.
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EC approves Libtayo® for metastatic cervical cancer
The European Commission has approved Libtayo® for cervical cancer and disease progression while on or after platinum-based chemotherapy, due to positive Phase III trial results.
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NICE recommends combo therapy for gastroesophageal cancer
Nivolumab together with chemotherapy has been recommended in NICE final draft guidance for treatment of gastroesophageal cancer.
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FDA approves first gene therapy for Haemophilia B
Hemgenix, the first gene therapy for adults with Haemophilia B has been approved by the US Food and Drug Administration (FDA).
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First clinical trial to test novel heart attack drug
The first clinical trial for new heart attack drug glenzocimab, will evaluate its ability to reduce heart damage following a heart attack.
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FDA priority review for AbbVie lymphoma bispecific antibody
The FDA has accepted priority review of epcoritamab for adults with relapsed/refractory large B-cell lymphoma, which could be the first subcutaneous bispecific antibody for large B-cell lymphoma.
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Therapeutic-first for cold agglutinin disease haemolytic anaemia
The European Commission has approved Enjaymo®, the first-and-only approved therapeutic for haemolytic anaemia in adults with cold agglutinin disease.
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FDA approves first drug to delay type 1 diabetes
The US Food and Drug Administration (FDA) has approved Tzield, the first drug that can help delay the onset of stage 3 type 1 diabetes in patients over eight years old with stage 2 type 1 diabetes.
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MHRA approves first gene therapy for infusion into the brain
Upstaza™, approved for UK patients 18 months and over, is the first gene replacement therapy infused directly into the brain for the treatment of AADC deficiency.
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NICE recommends new treatment for EGFR-positive lung cancer
New therapy Mobocertinib, recommended by NICE, helps slow growth of EGFR-positive non-small-cell lung cancer in platinum-based chemo-treated patients.
