First cell therapy approved for Type 1 diabetes
US Food and Drug Administration (FDA)-approved allogeneic pancreatic islet cell therapy Lantidra could provide another treatment option for Type 1 diabetes.
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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.
Eli Lilly ulcerative colitis antibody drug doubles remission rates
Mirikizumab, the first therapeutic antibody tested for blocking interleukin-23 in ulcerative colitis has demonstrated strong efficacy in two Phase III trials.
UK trial to test psilocin-based drug for major depressive disorder
A first-of-its-kind trial testing a novel psilocin-based drug for major depressive disorder has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA).
Could obicetrapib facilitate sufficient LDL-cholesterol levels?
Data shared at the National Lipid Association (NLA) Scientific Sessions 2023 demonstrated that obicetrapib with ezetimibe reduced low-density lipoprotein cholesterol (LDL-C) while increasing HDL-C, compared with high-intensity statin monotherapy.
HPLC market projected to value $8 million by 2030
Research has shown that the global high-performance liquid chromatography (HPLC) market is being driven by the need for precise analytical tools in drug development and quality control (QC).
Alzheimer’s vaccine granted Fast Track designation
The US FDA has given Fast Track designation to an active immunotherapy vaccine that “specifically targets the most toxic forms of amyloid beta (Abeta)”.
FMF World Congress 2023: Janssen shares new data in HDFN
If approved, nipocalimab would be the first anti-FcRn therapy for EU pregnancies at high risk of haemolytic disease of the foetus and newborn.
Lonza and Vertex to partner to manufacture diabetes cell therapies
The proposed collaboration between Lonza and Vertex Pharmaceuticals will support manufacture of stem cell-derived, fully differentiated insulin-producing islet diabetes cell therapies.
FDA publishes recommendations on psychedelic clinical trial design
New draft guidance published by the US Food and Drug Administration (FDA) is intended to aid clinical study design in psychedelic drug development programmes.
TAK-755 trumps plasma-based therapy, trial shows
Compared to plasma-based therapies, the only recombinant ADAMTS13 protein in development showed strong efficacy in a trial for congenital thrombotic thrombocytopenic purpura (cTTP), Takeda revealed.
How can real-world evidence support regulatory decision making?
Strategies to further accelerate real-world evidence generation to aid EU regulatory decision-making are needed, states a European Medicines Agency (EMA) report.
First RNA CAR-T therapy autoimmunity trial shows potential
A novel RNA CAR-T cell therapy demonstrated long-term clinical benefit for most generalised myasthenia gravis (gMG) patients in a landmark study.
Reducing bioburden testing and sterility testing volumes for gene therapies
A reduced sampling plan was recommended in a Biophorum report for reducing required bioburden and sterility testing volumes for gene therapy batch yield.
Gene therapy approved for Duchenne muscular dystrophy
The first approved gene therapy for certain paediatric Duchenne muscular dystrophy (DMD) patients leads to production of the Elevidys micro-dystrophin protein.
