The positive opinion has been issued via the MHRA’s early access the medicine (EAMS) scheme
News
NICE to develop guideline for rare blood clots associated with COVID-19 vaccination
Condition is ‘extremely’ rare, with only 14.2 cases occurring per million doses of the COVID-19 vaccine
NHS invests £20m to fast-track measures for quick cancer diagnosis
Funding will go towards a number of measures aimed at speeding up cancer diagnosis and treatment
Bayer’s Kerendia approved in the US to slow CKD in type 2 diabetes patients
The approval is based on data from the Phase III FIDELIO-DKD renal outcomes study
AZ scores final clearance for Alexion acquisition in the UK
UK approval of the acquisition comes just a week after the merger scored clearance in the EU
Quidel gains CE mark for combined COVID-19, flu and RSV diagnostic test
Company’s molecular testing platform and first assay panel can now be marketed in the EU
Aetion and Cegedim expand real-world data partnership
In 2020, the two partners announced an initial collaboration to integrate Cegedim’s ‘THIN’ European real-world data into Aetion’s evidence platform
Tecentriq, Kesimpta lead latest SMC decisions
SMC was unable to accept Pfizer’s Vyndaqel for use in patients with transthyretin amyloidosis
New hope for long COVID blood tests after antibody discovery
Researchers discover presence of ‘autoantibodies’ in people with persistent COVID-19 symptoms
Galapagos’ filgotinib leads to rapid symptom improvement for ulcerative colitis patients
Data also suggested filgotinib 200mg reduced and eliminated corticosteroid use compared to placebo
Almost 50,000 extra doctors needed in England, says BMA
BMA research finds the number of doctors per 1,000 people in England is 25 years behind comparable EU nations
PHE study finds COVID-19 vaccines ‘highly effective’ in at-risk groups
Vaccine effectiveness against symptomatic disease in at-risk groups is approximately 60% after one dose of either the AZ or Pfizer/BioNTech vaccines
NICE ‘no’ for Orchard Therapeutics’ gene therapy Libmeldy
NICE concluded the cost-effectiveness estimates for Libmeldy are unlikely to be within the range that it would consider an effective use of NHS resources
Valneva’s chikungunya virus vaccine granted breakthrough designation
Currently, no preventative vaccines or effective treatments are available for the chikungunya virus
Expanded access for Zolgensma following final NICE guidance
NHS bodies in Wales and Northern Ireland are now expected to consider providing access to SMA gene therapy
