MHRA

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 […]

The MHRA has approved Colonis’ Melatonin 1mg/ml Oral Solution for sleep onset insomnia in children and adolescents aged 6-17 years with attention-deficit hyperactivity disorder (ADHD), where sleep hygiene measures have been inadequate. Clinical evidence demonstrates that Melatonin has the potential to decrease sleep latency and increase sleep efficiency in children with ADHD and chronic sleep […]

The MHRA has granted marketing authorisation for Eli Lilly’s baricitinib (Olumiant), the first licensed JAK inhibitor for the treatment of severe alopecia areata in adult patients.   The authorisation was based on BRAVE-AA1 and BRAVE-AA2 studies which both met the primary endpoint of the proportion of patients achieving SALT ≤20 (i.e., 80% or more scalp hair […]

News round-up by DDW Editor Reece Armstrong for 15-19 August. Covid booster approvals, positive results for Malaria vaccines and new CEOs are some of the stories in this week’s news round-up.  MHRA approves Moderna’s bivalent Covid booster   The Medicines and Healthcare products Regulatory Agency (MHRA) has approved an updated version of Moderna’s Covid-19 booster vaccine […]

The Medicines and Healthcare products Regulatory Agency (MHRA) has granted Marketing Authorisation to Novartis UK’s treatment for a specific type of cancer.  The authorisation was granted for Scemblix (asciminib), Novartis UK’s therapy for adults with Philadelphia chromosome-positive chronic myeloid leukaemia (Ph+ CML) in chronic phase (CP) who have previously been treated with two or more tyrosine […]