All Pharmacovigilance and safety oversight articles – Page 31
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NewsFDA approves first treatment for geographic atrophy
The first-ever treatment for geographic atrophy has been approved by the US Food and Drug Administration (FDA).
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NewsEC approves first gene therapy for haemophilia B
The first gene therapy for haemophilia B has been given conditional marketing authorisation in Europe by the European Commission.
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NewsEMA releases human medicines highlights 2022 report
Medicines which represented significant progress in their therapeutic areas have been listed in the European Medicines Agency's Human Medicines Highlights 2022 report.
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NewsFusion to acquire radiologand therapy for prostate cancer
An investigational new drug application for an ongoing Phase II trial of an alpha-emitting radiopharmaceutical will be acquired by Fusion Pharmaceuticals.
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NewsNeoadjuvant nivolumab improves long-term survival for lung cancer
Analysis of a Phase II trial for non-small cell lung cancer has suggested neoadjuvant nivolumab improved five-year recurrence-free survival compared with historical outcomes.
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ArticleKey developments: mRNA vaccines and therapeutics
EPR summarises results from key mRNA vaccine trials, highlighting the future potential of these innovative therapeutics.
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NewsCAR T-cell therapy offers substantial remission rates in trial
In a Phase III study, a CAR T-cell therapy more than tripled progression-free survival compared with standard care for triple-class exposed multiple myeloma.
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NewsNovel two-chamber setup could predict HPAPI dustiness
A two-chamber setup (TCS) for containment investigations could predict the dustiness of HPAPIs in a sealed system at different flow conditions.
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NewsFDA gives first RMAT designation to a cardiac gene therapy
A regenerative medicine advanced therapy (RMAT) designation has been given to a gene therapy for Danon disease by the US Food and Drug Administration (FDA).
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NewsBMS in-licensed PKC theta inhibitor enters clinical trials
A potentially first-in-class PKC theta inhibitor, in development for immunology and inflammation indications, has entered first-in-human trials in the US.
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NewsFirst-in-class therapy shows potential for chronic fibrosis
A novel, first-in-class oral therapy showed meaningful improvement in over half of scleroderma patients in a Phase II trial for serious inflammatory and fibrotic diseases.
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NewsMHRA approves first oral advanced therapy for Crohn’s disease
The MHRA has approved the first marketing authorisation globally for the use of RINVOQ®▼ (upadacitinib) in Crohn's disease.
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NewsFirst medicine approved in EU for eosinophilic esophagitis
Dupixent® has been approved by European Commission as the first and only targeted medicine indicated for eosinophilic esophagitis.
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NewsFDA approves first BTK inhibitor for lymphoma
The first BTK inhibitor of any kind approved for mantle cell lymphoma treated with a covalent BTK inhibitor, has been granted FDA approval.
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NewsCHMP meeting highlights – January 2023
Four new medicines were recommended for approval at the Committee for Medicinal Products for Human Use (CHMP)’s January meeting, with positive opinions given to two type 2 diabetes drugs.
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NewsMonoclonal antibody could prevent malaria, study shows
Based on recent research, a "potential game changer” approach could offer a practical way to use monoclonal antibody therapies for malaria in Africa.
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NewsNew UK point of care manufacturing regulatory framework
A first-of-its-kind regulatory framework for point of care manufacturing of innovative medicines is set to be introduced in the UK, ensuring these products are as safe as conventional medicines.
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NewsEnhertu approved in EU for HER2-low breast cancer
The European Commission has approved Enhertu in the EU as the first HER2-directed therapy for patients with HER2-low metastatic breast cancer.
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NewsFirst CAR T-cell therapy recommended on NHS
NICE’s recommendation of Yescarta® means it is the first time patients will be able to access CAR T-cell therapy long-term on the NHS.
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NewsWHO urges supply chain to take action on contaminated medicines
Key stakeholders in the medicine supply chain have been urged by the World Health Organization to take immediate action against recent cases of contaminated medicines.