MHRA

CSL’s Hemgenix (etranacogene dezaparvovec) has been authorised as the first gene therapy for adults with severe and moderately severe haemophilia B (congenital Factor IX (FIX) deficiency) in Great Britain. It has been granted a marketing authorisation for patients without a history of FIX inhibitors by the UK Medicines and Healthcare products Regulatory Agency (MHRA). The […]

iOnctura, a clinical stage biotechnology company developing breakthrough therapies for patients suffering with cancer, has been awarded the innovative medicine designation, the Innovation Passport, for roginolisib, for the treatment of metastatic uveal melanoma by the Medicines & Healthcare products Regulatory Agency (MHRA).  Roginolisib is a first-in-class, non-ATP-competitive, allosteric modulator of PI3Kd which prevents tumour proliferation […]

A series of new measures will be introduced by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to make it faster and easier to gain approval and run clinical trials in the UK. These changes represent the biggest overhaul in UK clinical trials regulation in over 20 years and are designed to make the […]

There was some good news for the UK life sciences sector in the government’s Spring Budget, but did it go far enough? DDW’s Diana Spencer takes a look at the industry’s reaction. There wasn’t much to write home about in the UK government’s Spring Budget, described by Bloomberg UK’s Marcus Ashworth as a “minimalist masterclass”. […]

The Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation to AstraZeneca for Imfinzi (durvalumab) in combination with gemcitabine and cisplatin in Great Britain for use as a first-line treatment of adults with locally advanced, unresectable or metastatic biliary tract cancer (BTC).1 This authorisation by the MHRA has been issued under Project Orbis, […]

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Takeda’s vaccine candidate Qdenga for active immunisation against dengue infection from four years of age.  Dengue is the fastest spreading mosquito-borne virus and was recognised by the World Health Organization (WHO) in 2019 as one of the top ten threats to […]

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 […]