The FDA has approved BioMarin’s Roctavian (valoctogene roxaparvovec) for adults with severe haemophilia A. Currently, around half of the patients who have the most severe form of haemophilia A undergo intravenous Factor VIII (FVIII) infusions two to three times per…
FDA grants Priority Review of Astellas’ zolbetuximab BLA
Astellas Pharma Inc has announced that the US Food and Drug Administration (FDA) has accepted and granted Priority Review of its zolbetuximab Biologics License Application (BLA). If approved, the first-in-class investigational Claudin 18.2 (CLDN18.2)-targeted monoclonal antibody would be the first…
AI-based heart disease tool wins Future NHS Award
A digital tool developed by researchers in the NHS that is being used to speed up the diagnosis of heart disease has won this year’s Future NHS Award, which recognises outstanding contributions from the health service workforce. The artificial intelligence-powered…
FDA approves first progression-slowing Alzheimer’s drug
Yesterday the US Food and Drug Administration granted full approval to Eisai and Biogen’s Leqembi (lecanemab-irmb), making it the first approved Alzheimer’s treatment clinically shown to slow disease progression and cognitive and functional decline. Though these benefits are modest –…
Boehringer and Zealand step into obesity market with positive Phase II data
Boehringer and Zealand released Phase II data with the investigational drug survodutide, while Novo Nordisk presented new Ozempic data. At the American Diabetes Association’s 83rd Scientific Sessions, Boehringer Ingelheim and Novo Nordisk took another step in the obesity arena with…
First ‘tooth regrowth’ drug to enter human clinical trials in 2024
‘Tooth regrowth’ drug, if successful, can aid people to grow a new set of teeth who lack them due to a congenital condition called Anodontia In a breakthrough, a team of Japanese scientists has developed a drug that can regenerate…
First AI-generated small molecule drug enters Phase II trial
Insilico Medicine’s novel AI-generated small molecule inhibitor drug represents a new milestone in pharmaceutical drug development. The world’s first AI-generated anti-fibrotic small molecule inhibitor drug has been administered to the first human patients. Phase II clinical trials in the US…
Australia first to prescribe MDMA and psilocybin for depression, PTSD
On 1st July, Australia became the first country to allow psychiatrists to prescribe MDMA, also known as ecstasy, for PTSD. Psilocybin, the psychoactive ingredient in hallucinogenic (or ‘magic’) mushrooms, can also be given to those with treatment resistant depression (TRD).…
Study shows psilocybin offers cost-effective solution for major depression
Psilocybin, a psychedelic compound found in certain mushrooms, could offer a more cost-effective treatment option for major depressive disorder than current methods, according to research from Clerkenwell Health and the University of Greenwich. Findings from the study, titled ‘Cost-effectiveness of psilocybin-assisted therapy…
FDA grants Priority Review of Astellas’ zolbetuximab BLA
Astellas Pharma Inc has announced that the US Food and Drug Administration (FDA) has accepted and granted Priority Review of its zolbetuximab Biologics License Application (BLA). If approved, the first-in-class investigational Claudin 18.2 (CLDN18.2)-targeted monoclonal antibody would be the first…
