Scottish Medicines Consortium (SMC)

Human eye
#AMD #Monoclonal antibodies #Ophthalmology #Outlook Therapeutics #Scottish Medicines Consortium (SMC)

Bevacizumab gamma gets Scottish OK for wet AMD

The Scottish Medicines Consortium (SMC) has approved Lytenava (bevacizumab gamma) for the treatment of wet age-related macular degeneration (wet AMD).   It is the first licensed ophthalmic formulation of bevacizumab for use in treating wet AMD in adults in the EU and the UK and has an initial 10 years of… Read More

#News #Regulatory

Scotland flag
#Chemotherapy #Hearing Loss #NHS Scotland #Norgine #Scottish Medicines Consortium (SMC)

SMC okays Pedmarqsi to prevent cisplatin-induced hearing loss

Pedmarqsi (sodium thiosulfate solution for infusion) has become the first treatment to be made available within NHS Scotland for the prevention of ototoxicity (hearing loss) induced by cisplatin chemotherapy in patients up to 18 years of age with localised, non-metastatic, solid tumours.  The decision follows that of the National Institute… Read More

#News #Regulatory

Breast cancer
#AstraZeneca #Breast cancer #Cancer research #NHS Scotland #Scottish Medicines Consortium (SMC)

SMC accepts AstraZeneca’s breast cancer treatment

AstraZeneca’s Lynparza (olaparib) has been accepted for use within NHS Scotland by the Scottish Medicines Consortium (SMC) to treat adults with HER2-negative, locally advanced or metastatic breast cancer with germline BRCA1 or BRCA2 mutations after chemotherapy. Breast cancer prevalence In Scotland, nearly 5,000 people are diagnosed with breast cancer each… Read More

#Cancer Research #News

Scotland flag
#Oncology #Phase III trial #Regeneron Pharmaceuticals #Scottish Medicines Consortium (SMC)

Scotland approval for cervical cancer therapy

The Scottish Medicines Consortium (SMC) has accepted Libtayo (cemiplimab) for use on the National Health Service (NHS) as a second-line monotherapy for adults with recurrent or metastatic cervical cancer.  It is approved in patients who have disease progression on or after platinum-based chemotherapy, irrespective of PD-L1 expression level or tumour… Read More

#News #Regulatory

#European Commission #FDA #Regulatory #Scottish Medicines Consortium (SMC)

New DDW Highlights podcast: 27 August 2024

The latest episode of the DDW Highlights podcast is now available to listen to below. DDW’s Megan Thomas narrates five key stories of the week to keep DDW subscribers up-to-date on the latest industry updates. It’s been a busy week for medical regulatory agencies, with a number of key… Read More

#News

#European Commission #FDA #Regulatory #Scottish Medicines Consortium (SMC)

New DDW Highlights vodcast: 27 August 2024

Every week, DDW’s Megan Thomas narrates five key stories of the week to keep DDW subscribers up-to-date on the latest industry updates in the DDW Highlights podcast. It is now also available in a concise vodcast format.   It’s been a busy week… Read More

#News

#European Commission #FDA #Regulatory #Scottish Medicines Consortium (SMC)

This week in drug discovery (19-23 August) 

News round-up for 19-23 August by DDW Senior Digital Content Editor Diana Spencer. It’s been a busy week for medical regulatory agencies, with a number of key decisions made on therapies for graft-versus-host-disease, neuroendocrine carcinoma, haemophilia B, lymphoma and non-small cell lung cancer. The top stories:… Read More

#News

Gene therapy for haemophilia
#CSL #Gene therapy #Haemophilia #Scottish Medicines Consortium (SMC)

First gene therapy for haemophilia B accepted in Scotland

The Scottish Medicines Consortium (SMC) has accepted CSL Behring’s Hemgenix (etranacogene dezaparvovec) for use within NHS Scotland on an interim basis, until full marketing authorisation is granted. The single infusion gene therapy is recommended for adults with severe or moderately severe haemophilia B without a history of FIX inhibitors. The… Read More

#News #Regulatory

Stamp of approval
#Chiesi #Dermatology #Plant-based #Rare disease #Scottish Medicines Consortium (SMC)

Two rare disease therapies approved in Scotland

The Scottish Medicines Consortium (SMC) has published final advice on two rare disease therapies. Elfabrio (pegunigalsidase alfa), a novel enzyme replacement therapy (ERT), has been approved as a treatment option for Fabry disease in adults. Also, birch bark extract gel has been approved as a treatment option for junctional and… Read More

#News #Regulatory

Scotland
#Lymphoma #Marketing approval authorisation #NHS Scotland #Scottish Medicines Consortium (SMC) #Ulcerative colitis (UC) #Weight loss

Scottish Medicines Consortium advises on six new drugs

The Scottish Medicines Consortium (SMC), which advises on newly licensed medicines for use by NHS Scotland, has published advice on six medicines. 1. Tirzepatide (Mounjaro) was accepted for weight management in adults and is to be used alongside diet and exercise to help people lose weight. It was also given… Read More

#News #Regulatory

Endometrial biopsy
#GSK #Oncology #Scottish Medicines Consortium (SMC) #Women's health

GSK’s endometrial cancer therapy approved in Scotland

The Scottish Medicines Consortium (SMC) has accepted GSK’s dostarlimab as a treatment for adult patients with endometrial cancer when used in combination with platinum-containing chemotherapy. Specifically, dostarlimab will be used for patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer and who are candidates for… Read More

#News #Regulatory

Scotland
#Biologics #Dermatology #Novartis #Scottish Medicines Consortium (SMC)

New biologic approved in Scotland for hidradenitis suppurativa

Novartis’ Cosentyx (secukinumab) is now available in Scotland, following positive advice from the Scottish Medicines Consortium (SMC). It is licensed for adults with active moderate to severe hidradenitis suppurativa (HS) (acne inversa) who have responded inadequately to conventional systemic HS therapy. The advice applies for use in adult patients with… Read More

#News #Regulatory

Scotland
#Gilead Sciences #hepatitis #Immunology / Virology & Vaccines #Marketing approval authorisation #Scottish Medicines Consortium (SMC)

Scottish regulator approves first chronic hepatitis delta virus drug

The Scottish Medicines Consortium (SMC) has become the first UK health authority to permit routine NHS use of Gilead Sciences’ Hepcludex (bulevirtide) for the treatment of chronic hepatitis delta virus (HDV) infection. The drug has been accepted for the treatment of chronic HDV infection in adult patients with evidence of… Read More

#News #Regulatory

Non-small cell lung cancer
#Biomarkers #Lung cancer #Merck #Oncology #Phase II trial #Precision medicine #Regulatory #Scottish Medicines Consortium (SMC)

SMC approves targeted treatment for lung cancer

Following a resubmission from manufacturer Merck, the Scottish Medicines Consortium (SMC) has now approved Tepmetko (tepotinib) for use on the NHS in Scotland.   It is recommended for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harbouring mesenchymal-epithelial transition factor gene (MET) exon 14 (METex14) skipping alterations.  … Read More

#News #Regulatory

NHS Scotland A&E department
#AstraZeneca #Hyperkalaemia #Lokelma #NHS Scotland #Scottish Medicines Consortium (SMC)

Lokelma now available in emergency setting in Scotland

The Scottish Medicines Consortium (SMC) has updated its advice for AstraZeneca’s Lokelma (sodium zirconium cyclosilicate [SZC]) for adult patients with hyperkalaemia in Scotland.   Patients can now access SZC in the emergency care setting for the treatment of acute, life-threatening hyperkalaemia alongside standard care.  SZC is already used within NHS Scotland… Read More

#News #Regulatory

Dialysis machine
#Chronic kidney disease (CKD) #Scottish Medicines Consortium (SMC)

New treatment option for Scottish kidney transplant patients

The Scottish Medicines Consortium (SMC) has ruled Idefirix (imlifidase) clinically and cost-effective in highly sensitised adult patients prior to kidney transplant from a deceased donor.  The recommendation, which follows a positive ruling by the National Institute of Health and Care Excellence (NICE), marks an important milestone as highly sensitised patients… Read More

#News #Regulatory