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FDA 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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Drug Safety
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BMS 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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First-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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MHRA 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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First 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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FDA 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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CHMP 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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Monoclonal 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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New 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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Enhertu 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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First 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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WHO 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.
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EMA validates first regulatory submission for CRISPR-based medicine
The first regulatory submission for a CRISPR-based therapy has been validated by the European Medicines Agency, to treat sickle cell disease and transfusion-dependent beta thalassemia.
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Largest global clinical site hires all-female key leaders in Europe
Three all-female key leaders in Europe have been hired by Velocity Clinical Research, the largest clinical sites business globally.
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Onivyde® improves survival in Phase III pancreatic cancer trial
Onivyde® (irinotecan liposome injection) treatment regimen significantly improved survival in a Phase III trial compared to nab-paclitaxel plus gemcitabine.
