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EMA 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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Regulation & Legislation
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Enzyme replacement therapy for alpha-mannosidosis gets FDA approval
The first and only enzyme replacement therapy approved for alpha-mannosidosis in the US has been cleared for adult and paediatric patients.
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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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Forxiga approved in EU for chronic heart failure
Forxiga (dapagliflozin) has been approved in the EU for chronic heart failure across the full spectrum of left ventricular ejection fraction.
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Five potential EU regulatory changes impacting the life sciences industry in 2023
Elizabeth Anne Wright, Head of the EU regulatory life sciences team at law firm Cooley, and associates Jessica Koffel and Edward Turtle look ahead at EU regulatory milestones for the life sciences sector in 2023. Five key areas of potential change include: clinical trials, medical devices, pharmaceutical legislation, class actions…
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ABPI warns against revenue clawback rate rises
The Association of the British Pharmaceutical Industry (ABPI) has urged immediate government action is needed against the planned UK statutory revenue clawback rate rise for branded medicines.
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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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Whitepaper: Rapid adoption of medication adherence and smart packages – key factors driving interest and consideration
Read this whitepaper to understand the power of digital technologies in advancing medication adherence during clinical trials.
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Clinical Trials Information System mandatory in EU
Use of the Clinical Trials Information System is now mandatory for new clinical trial applications in the EU, says the European Medicines Agency.
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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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Citrate-free HCF of adalimumab biosimilar gets positive opinion
A positive opinion has been adopted by the CHMP for a citrate-free high concentration formulation of its biosimilar Hyrimoz® (adalimumab).
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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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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.
