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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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Biologics
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2022 WHO Biosimilar Guideline improves access, IGBA says
Under the revised 2022 WHO Biosimilars Guideline, IGBA says regulatory authorities can confidently revaluate biosimilar access requirements.
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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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EMA human medicines committee (CHMP) highlights, November 2022
The Committee for Medicinal Products for Human Use (CHMP)’s November meeting consisted of approval recommendations for four medicines, including a biosimilar for osteoporosis and a new COVID-19 vaccine.
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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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Swedish innovation agency invests in new ATMP QC method
A new project funded by Swedish innovation agency Vinnova, will help develop an AI-based quality control method for ATMP manufacturing.
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First patients given lab-grown blood cell transfusion
The second-ever patient has been transfused with lab-grown red blood cells in a clinical trial, promising an effective treatment for patients.
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Alternative immunotherapies improve relapsed myeloma survival
Alternative CAR-T and cell therapies increased relapsed multiple myeloma patient survival by 18 months after failed CAR-T, a study found.
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Breakthrough Therapy Designation for Pfizer bispecific antibody
A bispecific antibody for multiple myeloma gets Breakthrough Therapy Designation based on 61 percent overall response trial data.
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Psilocybin improves depression symptoms, study shows
According to a new study, 25mg of psilocybin alongside psychological support, greatly reduces symptoms in participants with treatment-resistant depression.
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First virtual clinical trial examines two promising Alzheimer’s drugs
A first-of-its-kind simulated clinical trial has modelled long-term health outcomes for two key Alzheimer’s drugs to determine optimal treatments.
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Live from CPhI: ‘Gut microbiome therapy to be approved in the next two years’
The promise of microbiome-based therapeutics is rapidly progressing towards real world applications as treatment of recurrent Clostridium difficile using faecal microbiota transplant edges towards a BLA.
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Case study: Reduce plate counting costs and delays
Learn how a US influenza vaccine manufacturer concerned with intermittent positive plate counts used rapid microbial monitoring to save time and money.
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EMA validates AbbVie lymphoma bispecific antibody application
AbbVie's marketing application for epcoritamab in adults with relapsed/refractory diffuse large B-cell lymphoma has been validated by the European Medicines Agency.
