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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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Clinical Trials
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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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Advanced Biodesign starts first-in-human clinical trial targeting AML
After receiving an approval from France's National Agency for Medicinal Safety and Health Products (ANSM), Advanced BioDesign announced the enrolment of the first patient in its first-in-human clinical trial in acute myeloid leukaemia.
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Edible sensor delivers real-time antiretroviral dosage data
HIV patients received real-time antiretroviral dosage data from an innovative edible sensor in a clinical trial.
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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.
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Could Astellas antibody be first-line treatment for gastric cancer?
Monoclonal antibody Zolbetuximab plus mFOLFOX6 achieved significant progression-free survival in a Phase III trial for advanced gastric and gastroesophageal junction cancers.
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First implantable pump kills brain cancer using chemo
The first implantable pump system bypassed the blood-brain barrier to deliver chemotherapy to brain cancer patients in a Phase I study.
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First-in-class oral antibiotic improves tuberculosis
GSK’s low dose, daily oral antitubercular agent improved drug-susceptible pulmonary tuberculosis after 14 days, giving it potential as a simpler treatment option.
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Early efficacy of arthritis therapy predicts long-term benefits
Tremfya® trial analysis showing early skin and enthesitis response for active psoriatic arthritis could indicate long-term clinical response including disease remission.
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First oral treatment approved for post-transplant refractory cytomegalovirus
The EC has authorised the first UL97 protein kinase inhibitor for adults with post-transplant refractory cytomegalovirus infection.
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Heart failure: clinical trials update 2022
EPR rounds up results from several key clinical trials on therapies for hypertension and heart failure presented at the American Heart Association’s Scientific Sessions 2022.
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Oligonucleotide therapy helps to prevent chronic hepatitis B
Bepirovirsen, an antisense oligonucleotide therapy aided in long-term prevention of chronic hepatitis B in patients on and not on nucleoside/nucleotide analogues in a Phase II trial.
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First needle-free COVID-19 vaccine patch
If successful in further clinical trials an innovative, cost-effective COVID-19 vaccine patch could be available as early as 2025.
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Empagliflozin reduces risk of chronic kidney disease progression
A major trial evaluating Boehringer Ingelheim’s Jardiance®, showed it reduced the risk of cardiovascular death and chronic kidney disease progression by 28 percent.
