MHRA

The Medicines and Healthcare products Regulatory Agency (MHRA) has authorised the world’s first gene therapy for sickle-cell disease (SCD) and transfusion-dependent β-thalassemia (TDT). Casgevy (exagamglogene autotemcel, or exa-cel) is the first medicine to be licensed that uses gene editing tool CRISPR, for which its inventors were awarded the Nobel Prize in 2020. The treatment from […]

The US Food and Drug Administration has approved Zepbound (tirzepatide) injection for chronic weight management alongside a reduced calorie diet and increased physical activity. It is approved in adults with obesity (body mass index of 30 kilograms per square meter (kg/m2) or greater) or overweight (body mass index of 27kg/m2 or greater) with at least […]

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has authorised a new indication for anastrozole, to prevent breast cancer in post-menopausal women at moderate or high risk of developing the disease. The hormone treatment was already authorised for use in the treatment of breast cancer in post-menopausal women and has been used off-label for […]

The UK regulator has approved a new treatment for non-small cell lung cancer (NSCLC) in adults that has a mutation and produces a rare protein called KRAS G12C. The Medicines and Healthcare products Regulatory Agency (MHRA) has authorised Krazati (adagrasib) to treat patients whose disease is advanced or has spread to other parts of the […]

UK regulatory authorities have approved the first trial of a gene therapy for young children with Hunter syndrome. The UK Medicines and Healthcare Products Regulatory Agency (MHRA), Research Ethics Committee (REC), and Health Research Authority (HRA) have all approved the clinical trial application that was submitted by The University of Manchester in August 2022. In […]

The MHRA has granted conditional marketing authorisation for Tepkinly (epcoritamab) as a bispecific treatment for adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. The conditional marketing authorisation for Great Britain is based on the single-arm Phase I/II EPCORE NHL-1 trial data, which demonstrated a 62% […]

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has revealed plans to reduce the time taken to approve the lowest-risk clinical trials by more than 50%. According to the plans, initial applications for the lowest-risk Phase III and IV trials will be processed by the MHRA within 14 days instead of the statutory 30 […]

Leucid Bio has been granted clinical trial authorisation by the UK Medicines and Healthcare products Regulatory Agency (MHRA) to initiate a Phase I/II clinical trial evaluating autologous NKG2D-targeted CAR-T cell therapy, LEU011, in patients with relapsed or refractory solid tumours. The open-label, single patient cohort ascending dose design aims to rapidly identify the maximum tolerated […]

Approval has been granted by the Medicines and Healthcare products Regulatory Agency (MHRA) for an adapted Pfizer/BioNTech Covid-19 vaccine that targets the Omicron XBB 1.5 subvariant. The new version of Comirnaty was found to meet the UK regulator’s standards of safety, quality and effectiveness and has been approved for use in individuals from six months […]

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted Aleta Biotherapeutics a clinical trial authorisation (CTA) to evaluate biologic ALETA-001 in a Phase I/II clinical trial in patients with B-cell malignancies who are relapsed/refractory to CD19 CAR-T cell therapy. The company’s collaboration partner, Cancer Research UK’s Centre for Drug Development, has sponsored and […]

Bimervax from HIPRA Human Health has been authorised in the UK after meeting the Medicines & Healthcare products Regulatory Agency’s (MHRA) required safety, quality and effectiveness standards. It becomes the ninth Covid-19 vaccine to be authorised by the UK’s independent medicines regulator. Bimervax combines a part of the SARS-CoV-2 virus spike protein with an adjuvant. […]

On 31 January 2020, the United Kingdom (UK) withdrew from the European Union (EU). Alongside a number of repercussions, the most impactful to the drug discovery sector arguably relates to regulatory affairs on account of adjusting from the European Medicines Agency (EMA) to the Medicines and Healthcare products Regulatory Agency (MHRA). DDW’s Megan Thomas evaluates […]

On 31 January 2020, the United Kingdom (UK) withdrew from the European Union (EU). Alongside a number of repercussions, the most impactful to the drug discovery sector arguably relates to regulatory affairs on account of adjusting from the European Medicines Agency (EMA) to the Medicines and Healthcare products Regulatory Agency (MHRA). DDW’s Megan Thomas evaluates […]

On 31 January 2020, the United Kingdom (UK) withdrew from the European Union (EU). Alongside a number of repercussions, the most impactful to the drug discovery sector arguably relates to regulatory affairs on account of adjusting from the European Medicines Agency (EMA) to the Medicines and Healthcare products Regulatory Agency (MHRA). This is the second […]

Following the death of a cancer patient after they were given an unlicensed drug, Diana Spencer unpacks the practice of prescribing unlicensed and off-label medicines. This month, a cancer patient died and three others were hospitalised in the UK after they were administered an unlicensed version of the chemotherapy drug cabazitaxel. In a statement, the […]

A cancer patient died and three others were hospitalised in the UK after they were administered an unlicensed version of chemotherapy cabazitaxel. According to The Guardian, which reported on the incident, the problem was caused by an issue at private healthcare company Sciensus’ medicines manufacturing unit. In a statement, Sciensus said that it was an […]