‘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…
AbbVie’s Migraine Drug Scores Another Phase III Win
Kicking off this year’s American Academy of Neurology annual meeting on Friday morning, AbbVie shared more positive results for its migraine drug, Qulipta (atogepant). Originally approved in 2021 for the preventative treatment of episodic migraine headaches, AbbVie has continued to…
FDA approves allogeneic stem cell transplant therapy
The first allogeneic stem cell transplant therapy to be approved based on Phase III study results has been granted by the US Food and Drug Administration (FDA). Omisirge® (omidubicel-onlv), now US Food and Drug Administration (FDA) approved, is the…
FDA approves first new B-cell lymphoma treatment in 20 years
A first-line B-cell lymphoma treatment shown to reduce the risk of disease progression or relapse by 27 percent has been approved by the FDA. The US Food and Drug Administration (FDA) has approved Polivy® (polatuzumab vedotin-piiq) in combination with Rituxan®…
Vertex/CRISPR file first gene-editing therapy with FDA
Vertex Pharma and CRISPR Therapeutics have become the first companies to file for FDA approval of a therapy based on gene-editing technology. The two partners have submitted a marketing application exagamglogene autotemcel (exa-cel, formerly CTX001) for blood disorders sickle cell…
Novo Nordisk, Aspect sign $2.6bn diabetes cell therapy deal
Novo Nordisk has put $75 million down on the table to partner Canadian biotech Aspect Biosystems’ cell-based therapies for diabetes and obesity. The upfront payment is backed by up to $650 million in milestones for each product that arises from…
