Decision is based on results from the Phase II DESTINY-Breast01 trial
News
NICE’s five-year strategy sets a ‘positive vision for the future’
Pharma and diagnostic sectors respond to organisation’s latest guideline recommendations
NICE unveils new strategy to improve patient access to innovative treatments
Five-year strategy will seek to transform key elements of organisation’s approach to latest treatments
Phico Therapeutics gains £13.1m grant to advance antibacterial therapy
SASPject PT3.9 is designed for the treatment of hospital infections caused by Pseudomonas aeruginosa
New advice on COVID-19 vaccination for pregnant women in UK
JCVI advises pregnant women in the UK be offered COVID-19 vaccination at the same time as the rest of the population
TG Therapeutics’ ublituximab tops Sanofi’s Aubagio in MS trial
Ublituximab significantly reduced the annualised relapse rate in patients with relapsing forms of multiple sclerosis
EC approves new Sarclisa indication
Sarclisa has been approved in combination with a standard of care regimen for relapsed multiple myeloma
New subcutaneous formulation of Tysabri approved in UK
Multiple sclerosis treatment can now be administered subcutaneously or intravenously
EMA begins review of GSK/Vir’s COVID-19 antibody
The review will include an interim analysis of efficacy and safety data from the Phase III COMET-ICE trial
Roche’s SMA treatment Evrysdi demonstrates continued improvements in infants
Drug continuously improved motor function and survival in babies after 24 months of treatment
NICE recommends Alexion’s PNH treatment Ultomiris
C5 complement inhibitor approved to treat PNH in adult patients with haemolysis
Alchemab completes £60m Series A funding to advance novel antibody platform
The funding will be used to advance Alchemab’s novel platform to identify disease-modifying antibody therapeutics
Magic mushroom compound psilocybin shows ‘promise’ in depression
Researchers from Imperial College London say compound is at least as effective as a leading antidepressant in a therapeutic setting
Amylyx Pharma plans to file ALS therapy with the EMA this year
The previously-reported CENTAUR study of AMX0035 in 137 participants with ALS met its primary endpoint of slowing ALS progression
GSK decides to halt mid-stage feladilimab studies
British drugmaker has discontinued treatment with investigational drug in two cancer trials
