MHRA

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted a licence extension for dapagliflozin for the treatment of symptomatic chronic heart failure (HF).  The drug is approved in patients with HF and a left ventricular ejection fraction (LVEF) >40%, including HF with mildly reduced ejection fraction (HFmrEF) and preserved ejection fraction (HFpEF).  HF […]

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has approved a CBD/THC combination treatment under its Named Patient programme and other compassionate areas. Medlab’s NanaBis, to be used under NanaDol, a botanical version of NanaBis, has previously shown encouraging Phase I/II data for the treatment of cancer-induced bone pain and could be a potential […]

England will become the first country in Europe to roll out darolutamide (Nubeqa) to patients whose prostate cancer has spread to other parts of the body.  The drug works by blocking androgen receptors in cancer cells, which in turn blocks the effect of testosterone that allows the cancer cells to survive and multiply. Studies show […]

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 news.  Gene therapies have made the headlines over the last week, with treatments for rare AADC deficiency, lung cancer and haemophilia B given […]

News round-up for 21-25 November by DDW Digital Content Editor Diana Spencer  Gene therapies have made the headlines over the last few days, with treatments for rare AADC deficiency, lung cancer and haemophilia B given the go ahead from regulators. This week has also seen the first immunomodulatory treatment for type 1 diabetes approved in the […]

PTC Therapeutics’ Upstaza (eladocagene exuparvovec) has received authorisation from the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK.   Upstaza is the first approved disease-modifying treatment for aromatic L-amino acid decarboxylase (AADC) deficiency. It is also the first marketed gene therapy directly infused into the brain. The MHRA marketing authorisation is for treatment of […]

The UK Medicines & Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Novartis’ Cosentyx (secukinumab) in two types of juvenile idiopathic arthritis (JIA), enthesitis-related arthritis (ERA), and juvenile psoriatic arthritis (JPsA).  The drug is approved alone or in combination with methotrexate (MTX) in patients six years and older whose disease has responded inadequately […]

Complement Therapeutics’ lead asset CTx001, an AAV-based gene therapy for the treatment of geographic atrophy (GA), has been awarded an Innovation Passport by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA).  CTx001 was awarded the Innovation Passport based on three criteria: that the condition addressed is seriously debilitating with a significant patient need; an […]

Global Phase III topline data is expected later this year for a new class of Covid-19 booster vaccine. Vaxxinity has completed enrollment for the trial, co-sponsored by the Coalition for Epidemic Preparedness Innovations (CEPI). Its UB-612 will be evaluated as a heterologous booster vaccine to mRNA, adeno-vectored, and inactivated primary series vaccinations.  “Completing enrollment in a […]

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved a new class of treatment for adults with insufficiently controlled type 2 diabetes.  Marketing authorisation has been granted for Eli Lilly’s tirzepatide (Mounjaro), a once-weekly GIP (glucose-dependent insulinotropic polypeptide) receptor and GLP-1 (glucagon-like peptide-1) as an adjunct to diet and exercise.  Tirzepatide is approved […]