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EC approves CAR T-Cell therapy for B-cell lymphoma
Yescarta approved by EC for the treatment of large B-Cell lypmphoma and high grade B-cell lymphoma.
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Drug Safety
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CHMP recommends dengue vaccine for children
Takeda’s novel dengue vaccine has received positive opinion from the EMA’s human medicines committee (CHMP), demonstrating the vaccine is safe for patients from four years old.
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CHMP recommends Pluvicto® for treating advanced prostate cancer
CHMP issues positive opinion on Pluvicto®, paving the way for it to become the first European-approved radioligand therapy for metastatic prostate cancer patients.
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Enterin and Parkinson’s UK to partner on dementia study
A new Phase II trial will study the drug ENT-01 for Parkinson’s Disease (PD)-associated dementia at sites in the UK and US.
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Could first anti-tau therapy be approved for Alzheimer’s?
The oral medication Hydromethylthionine mesylate (HMTM) is the first anti-tau disease-modifying therapy to offer sustained cognitive improvement in Alzheimer’s.
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First FDA pregnancy-approved Pertussis vaccine to protect newborns
The FDA has approved Boostrix, the first vaccine for pregnant women in their third trimester, to stop whooping cough (Pertussis) in infants below two months.
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NICE recommends first oral S1P receptor modulator for ulcerative colitis
NICE has recommended the drug Zeposia® (ozanimod) for moderate to severe cases of ulcerative colitis.
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Cystic fibrosis phage therapy trial commences
The National Institute of Allergy and Infectious Diseases (NIAID)-supported clinical trial will assess whether the bacteriophage therapy WRAIR-PAM-CF1 safely reduces the quantity of Pseudomonas aeruginos bacteria in fibrocystic lungs.
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Diagnostic approval facilitates more cancer patients treatment
The US FDA has approved Roche’s companion diagnostic test which identifies low HER2 expression in metastatic breast cancer, increasing pool of patients eligible for treatment with antibody drug conjugate Enhertu.
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Quantifying proteins en masse using coulometric mass spectrometry
Coulometric mass spectrometry (CMS) fully quantities proteins without using traditional lab sample testing standards, promising faster vaccine and drug advancement.
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Nitrogen dioxide for sterilisation of protein-filled polymer-based syringes
Nitrogen dioxide (NO2) gas found not to ingress and cause protein degradation when sterilising polymer-based prefilled syringes (P-PFSs), according to study.
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Serplulimab increases survival in small cell lung cancer patients
Hansizhuang (serplulimab), the world's first anti-PD-1 monoclonal antibody (mAb) treatment for extensive-stage small cell lung cancer (ES-SCLC), enhanced survival rates compared to chemotherapy, and is projected to be the leading immunotherapy for the disease in the next five years.
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CAR-T therapy safe for relapsed or refractory T-cell malignancies, finds study
A Phase I trial revealed that Bioheng Biotech’s chimeric antigen receptor (CAR) T-cell therapy drug RD13-01 was safe for use and that it could reduce malignant tumours.
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Injection could help postpartum depression, says study
Data demonstrated that a one-time injection of the drug BRII-296 is safe and effective for most patients with postpartum depression (PPD).
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Lecanemab diminishes mental deterioration in early Alzheimer’s
Phase III trial confirmed Eisai’s lecanemab significantly decreased cognitive decline in patients with mild Alzheimer’s disease.
