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EMA Recommends Six New Medicines for Approval

The European Medicines Agency's CHMP has recommended six new medicines for marketing authorisation and nine for extension of therapeutic indications. These recommendations cover treatments for various conditions including menopausal symptoms, liver disease, a rare genetic disorder, influenza, and graft-versus-host disease.

EMA Recommends Kygevvi for Rare TK2d Disease Treatment

The European Medicines Agency (EMA) has recommended granting a marketing authorisation for Kygevvi, a new treatment for the rare genetic disease thymidine kinase 2 deficiency (TK2d). This recommendation is based on clinical study data showing improvement in motor function for pediatric patients.

EMA Recommends Withdrawal of Levamisole Medicines

The European Medicines Agency (EMA) recommends the withdrawal of marketing authorisations for medicines containing levamisole due to the serious side effect of leukoencephalopathy. This recommendation follows an EU-wide review concluding that the benefits of these medicines no longer outweigh their risks for treating parasitic worm infections.

Levamisole withdrawn from EU market due to leukoencephalopathy risk

The EMA's PRAC has recommended the withdrawal of marketing authorisations for all medicines containing levamisole from the EU market. This decision is due to the confirmed risk of leukoencephalopathy, a serious brain side effect, where the benefits of the medicine no longer outweigh the risks for treating parasitic worm infections.

CVMP Opinions and Guidelines Update

The EMA's Committee for Veterinary Medicinal Products (CVMP) adopted positive opinions for several variations to existing veterinary medicinal products and discussed pharmacovigilance signals. These updates primarily involve product information changes based on signal management processes.

MHRA Raids Illegal Weight Loss Medicine Facility

The MHRA has raided two facilities suspected of manufacturing and selling illegal weight loss medicines, seizing nearly 2,000 doses and manufacturing equipment. This action is part of an ongoing investigation into a criminal network and aims to protect the public from dangerous, unregulated products.

MHRA Approves Imlunestrant Tosylate for Breast Cancer

The MHRA has approved imlunestrant tosylate (Inluriyo), a new treatment for adult patients with a specific type of advanced or metastatic breast cancer. This approval provides a new therapeutic option for patients who have not responded to prior hormonal treatment.

MHRA Alert: Fake Mounjaro (tirzepatide) KwikPens

The MHRA has issued a notice regarding fake Mounjaro (tirzepatide) 15mg KwikPens dispensed by The Private Pharmacy Clinic in Birmingham. Patients with affected pens are advised to stop use immediately and report to the MHRA. The manufacturer reported five faulty pens.

MHRA Class 2 Medicines Recall: KidNaps Melatonin Oral Solution

The MHRA has issued a Class 2 medicines recall for all batches of KidNaps Melatonin 1mg in 1ml Oral Solution due to out-of-specification stability results. Sterling Pharmaceuticals Ltd and Veriton Pharma Ltd are conducting the recall at the wholesaler and pharmacy level.

MHRA Licenses Brensocatib for Non-Cystic Fibrosis Bronchiectasis

The MHRA has granted a marketing authorisation for brensocatib (Brinsupri), the first medicine specifically designed to treat non-cystic fibrosis bronchiectasis (NCFB) in patients aged 12 years and older. This marks a significant advancement in treatment options for NCFB patients in the UK.